Functional Assessment Of Cancer Therapy-Breast Research Articles

NCOG-24. CHARACTERIZING NEUROTOXICITY ASSOCIATED WITH SYSTEMIC CHEMOTHERAPY IN PATIENTS WITH BREAST CANCER USING DOMAIN-SPECIFIC INTRA-INDIVIDUAL NEUROCOGNITIVE VARIABILITY

Abstract BACKGROUND Systemic chemotherapy is associated with neurotoxicity and neurocognitive functioning (NCF) changes. Intra-individual neurocognitive variability (IIV) is an index of NCF spread/dispersion across neuropsychological tests and can be elevated in patients with breast cancer (BC) after systemic chemotherapy. This study investigated longitudinal IIV changes within NCF domains after chemotherapy to determine whether: (1) IIV for NCF domains are more sensitive to changes than traditional mean-based metrics, and (2) whether changes in domain-specific IIV are associated with changes in mood disturbance or quality of life (QOL). METHODS Prior to and during/shortly after chemotherapy, 37 women with BC were administered a standardized NCF battery including tests within domains of attention/speed of information processing (A/SoP), learning/memory (L/M), and executive functions (EF). Within each domain, the coefficient of variation (CoV) was computed using the standard deviation of normatively-adjusted T-scores while adjusting for intra-individual mean. Patients were assessed for QOL using Functional Assessment of Cancer Therapy-Breast and mood using the STAI and BDI. RESULTS Paired samples t-tests revealed that mean NCF performances declined for L/M (t[36])=-4.44,p<.001,Hedge’s g=.70) and improved for A/SoP (t[36]=3.21,p=.003,g=.29), while CoV increased/worsened for L/M (t[36]=3.82,p<.001,g=.76) but did not change for A/SoP (t[36]=-0.05,p=.959,g=.01). There was no change in EF mean or CoV (ps >.10). No domain mean or IIV change was associated with mood changes (ps>.10). Mean NCF changes were not associated with QOL (ps >.10). Increased/worsened L/M CoV was associated with improved FACT-Breast scale QOL (ρ=.40,p=.020). CONCLUSIONS Both mean- and IIV-based NCF worsened for learning/memory. Discrepancies between mean and IIV change for attention/speed of information processing may be due to differential susceptibility to practice effects. Unexpected associations between learning/memory IIV changes and QOL require further investigation. Future studies are needed to examine NCF dispersion changes across treatment status and in other cancer populations.

Kinect-Based Mixed Reality Exercise Program Improves Physical Function and Quality of Life in Breast Cancer Survivors: A Randomized Clinical Trial.

Exercise is an effective non-pharmacological approach for alleviating treatment-related adverse effects and enhancing physical fitness in breast cancer survivors. A Kinect-based mixed reality device (KMR), with real-time feedback and user data collection, is an innovative exercise intervention for breast cancer survivors. This study aimed to investigate the effect of KMR exercise program on quality of life (QOL) and physical function in breast cancer survivors. Seventy-seven participants were randomly assigned to either the KMR exercise group or home stretching group with an 8-week intervention. Physical function (shoulder range of motion [ROM], body composition, aerobic capacity, and hand grip strength) was evaluated before and after the intervention period. Participants completed questionnaires such as the Disabilities of the Arm, Shoulder, and Hand (DASH), Functional Assessment of Cancer Therapy-Breast, and International Physical Activity Questionnaire (IPAQ) to assess upper extremity disabilities, QOL, and physical activity levels. Significant group-by-time interaction was found for flexion of the operated arm (154.3±12.5 to 165.8±11.2), and the non-operated arm (158.2±13.8 to 166.5±12.2), abduction of the non-operated arm (154.8±31.6 to 161.1±28.1), and adduction of the operated arm (46.5±9.1 to 52.6±7.2). Significant improvements were also observed in DASH (46.8±9.1 to 40.8±9.3) and IPAQ (1136.3±612.8 to 1287±664.1). The KMR exercise program effectively improved the physical function, alleviated edema, reduced upper extremity disability, and enhanced the QOL in breast cancer survivors. Coupled with significant group-by-time interactions for various outcomes, the results emphasize the potential benefits of incorporating the KMR exercise program to improve the QOL in breast cancer survivors.

Hypofractionated vs Conventionally Fractionated Postmastectomy Radiation After Implant-Based Reconstruction

Postmastectomy radiation therapy (PMRT) improves local-regional disease control and patient survival. Hypofractionation (HF) regimens have comparable efficacy and complication rates with improved quality of life compared with conventional fractionation (CF) schedules. However, the use of HF after mastectomy in patients undergoing breast reconstruction has not been prospectively examined. To compare HF and CF PMRT outcomes after implant-based reconstruction. This randomized clinical trial assessed patients 18 years or older undergoing mastectomy and immediate expander or implant reconstruction for breast cancer (Tis, TX, or T1-3) and unilateral PMRT from March 8, 2018, to November 3, 2021 (median [range] follow-up, 40.4 [15.4-63.0] months), at 16 US cancer centers or hospitals. Analyses were conducted between September and December 2023. Patients were randomized 1:1 to HF or CF PMRT. Chest wall doses were 4256 cGy for 16 fractions for HF and 5000 cGy for 25 fractions for CF. Chest wall toxic effects were defined as a grade 3 or higher adverse event. The primary outcome was the change in physical well-being (PWB) domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool at 6 months after starting PMRT, controlling for age. Secondary outcomes included toxic effects and cancer recurrence. Of 400 women (201 in the CF arm and 199 in the HF arm; median [range] age, 47 [23-79] years), 330 patients had PWB scores at baseline and at 6 months. There was no difference in the change in PWB between the study arms (estimate, 0.13; 95% CI, -0.86 to 1.11; P = .80), but there was a significant interaction between age group and study arm (P = .03 for interaction). Patients younger than 45 years had higher 6-month absolute PWB scores if treated with HF rather than CF regimens (23.6 [95% CI, 22.7-24.6] vs 22.0 [95% CI, 20.7-23.3]; P = .047) and reported being less bothered by adverse effects (mean [SD], 3.0 [0.9] in the HF arm and 2.6 [1.2] in the CF arm; P = .02) or nausea (mean [SD], 3.8 [0.4] in the HF arm and 3.6 [0.8] in the CF arm; P = .04). In the as-treated cohort, there were 23 distant (11 in the HF arm and 12 in the CF arm) and 2 local-regional (1 in the HF arm and 1 in the CF arm) recurrences. Chest wall toxic effects occurred in 39 patients (20 in the HF arm and 19 in the CF arm) at a median (IQR) of 7.2 (1.8-12.9) months. Fractionation was not associated with chest wall toxic effects on multivariate analysis (HF arm: hazard ratio, 1.02; 95% CI, 0.52-2.00; P = .95). Fewer patients undergoing HF vs CF regimens had a treatment break (5 [2.7%] vs 15 [7.7%]; P = .03) or required unpaid time off from work (17 [8.5%] vs 34 [16.9%]; P = .02). In this randomized clinical trial, the HF regimen did not significantly improve change in PWB compared with the CF regimen. These data add to the increasing experience with HF PMRT in patients with implant-based reconstruction. ClinicalTrials.gov Identifier: NCT03422003.

Emotional and functional well-being in long-term breast cancer survivorship.

Emotional and functional well-being (EWB and FWB) are important components of mental health and quality of life. This study aims to evaluate long-term EWB and FWB in breast cancer (BC) survivors. The Carolina Breast Cancer Study Phase 3 oversampled Black and younger (< 50years in age) women so that they each represent approximately 50% of the study population and assessed participants' EWB and FWB with the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 5- (baseline), 25-, and 84-months post diagnosis. Multinomial logit models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between demographic and clinical characteristics and well-being change relative to baseline. Among 2,781 participants with BC, average EWB and FWB improved with time since diagnosis. Persistent FWB decrements were associated with Black race [OR 1.4 (95% CI 1.2-1.7) and 1.3 (95% CI 1.1-1.6), at 25-months and 84-months respectively], older age [OR 1.4 (95% CI 1.1-1.7) and 1.5 (95% CI 1.2-1.8), respectively], no chemotherapy, and recurrence [OR 2.9 (95% CI 1.8-4.8) and 3.1 (95% CI 2.1-4.6), respectively]. EWB decrements were associated with advanced stage and recurrence. Decrements in combined (FWB+EWB) well-being were associated with recurrence at both follow-up survey timepoints [ORs 4.7 (95% CI 2.7-8.0) and 4.3 (95% CI 2.8-6.6), respectively]. Long-term well-being varies by demographics and clinical features, with Black women and women with aggressive disease at greatest risk of long-term decrements.

A protocol for a multidisciplinary early intervention during chemotherapy to improve dietary management behavior in breast cancer patients: a two-arm, single-center randomized controlled trial

BackgroundAdverse reactions are prone to occur in the early stage of chemotherapy and can negatively affect the dietary intake and nutritional status of breast cancer (BC) patients. Consequently, they need to participate in health self-management and lifestyle promotion programs. Early multidisciplinary interventions aim to enhance dietary management behavior and quality of life in chemotherapy-treated BC patients.MethodsThis single-blinded, single-center, randomized controlled trial will include 88 females who have not yet started the early or middle stage of the chemotherapy cycle. A random number table will be used randomly assign females to the intervention group or usual group at a 1:1 ratio. The intervention elements are based on the theoretical guidance of the Integrated Theory of Health Behavior Change (ITHBC). A multidisciplinary team (MDT) comprising oncologists, dietitians, nurses, traditional Chinese medicine (TCM) practitioners, and psychologists will provide the intervention. Intervention sessions will be conducted once a week for 8 weeks, beginning in the early or middle stage of the chemotherapy cycle and continuing through admission and a home-based interval chemotherapy period. The intervention includes face-to-face discussions, online meetings, WeChat messaging, and telephone calls. The themes target adverse reactions, dietary information and habits, self-care self-efficacy, treatment self-regulation, dietary supplement and TCM use, social support, weight management, and outcome expectations. The primary outcome is dietary management behavior measured by the Dietary Management Behavior Questionnaire (DMBQ). Secondary outcomes are self-care self-efficacy assessed by the Strategies Used by People to Promote Health (SUPPH); quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B); and body mass index (BMI) measured by an electronic meter. All participants will be assessed at baseline and immediately, 1 month, 3 months, 6 months, and 12 months after the intervention.DiscussionEarly dietary intervention is needed, as diet is one of the most common health self-management behaviors influenced by chemotherapy. Early multidisciplinary interventions may provide a foundation for dietary self-management and improve nutritional status in the survival period.Trial registrationThis intervention protocol was registered with the Chinese Clinical Trials Registry (ChiCTR2300076503, October 10, 2023).

Exercise and recovery after surgery in patients with breast cancer: An analysis of the literature

This review explores the impact of exercise on post-surgical recovery in breast cancer patients. Breast cancer, the most prevalent cancer globally, necessitates treatments beyond conventional modalities such as surgery, chemotherapy, radiotherapy, and immunotherapy. While exercise as an adjuvant therapeutic tool is not novel, it is generally accepted for improving cancer outcomes. Yet, it is not included in current treatment guidelines. This study reviews literature using the FACT-B (Functional Assessment of Cancer Therapy – Breast) tool to evaluate quality of life in breast cancer patients undergoing exercise interventions post-surgery. Despite mixed results, with some studies showing significant improvements and others indicating no notable benefits, the general consensus suggests potential advantages of integrating structured exercise programs into recovery protocols. Standardizing the use of quality of life measures like FACT-B could enhance future research and clinical practices, leading to more effective patient care strategies.

Application Value of Music Therapy in Improving the Emotional State and Quality of Life of Hospitalized Patients with Breast Cancer: Retrospective Study.

This study aimed to apply music therapy as a clinical treatment for patients with breast cancer (BC) experiencing mild or moderate depression during hospitalization and observe any improvements in their depression and quality of life. A total of 102 patients who had mild-to-moderate depression, were diagnosed with BC, and were admitted to our hospital from October 2022 to October 2023 were selected as the subjects of a retrospective analysis. According to their participation in short-term music therapy, they were divided into a control group (routine nursing treatment n = 45) and an observation group (routine nursing treatment + music therapy n = 57). Self-rating depression (SDS) scale and functional assessment of cancer therapy-breast (FACT-B) scale Chinese version 4.0 scores and patient satisfaction after treatment were compared between the two groups. After treatment, the SDS scale scores and FACT-B scores of the observation group were significantly better than those of the control group (P < 0.001). The patient satisfaction in the observation group was higher than in the control group (P < 0.05). Music therapy is a highly safe method to improve the depression and quality of life of patients with BC. It also provides a simple and convenient nondrug clinical treatment with broad application prospects.

Personalized and continuous care intervention affects rehabilitation, living quality, and negative emotions of patients with breast cancer

BACKGROUND Breast cancer is among the most common malignancies worldwide. With progress in treatment methods and levels, the overall survival period has been prolonged, and the demand for quality care has increased. AIM To investigate the effect of individualized and continuous care intervention in patients with breast cancer. METHODS Two hundred patients with breast cancer who received systemic therapy at The First Affiliated Hospital of Hebei North University (January 2021 to July 2023) were retrospectively selected as research participants. Among them, 134 received routine care intervention (routing group) and 66 received personalized and continuous care (intervention group). Self-rating anxiety scale (SAS), self-rating depression scale (SDS), and Functional Assessment of Cancer Therapy-Breast (FACT-B) scores, including limb shoulder joint activity, complication rate, and care satisfaction, were compared between both groups after care. RESULTS SAS and SDS scores were lower in the intervention group than in the routing group at one and three months after care. The total FACT-B scores and five dimensions in the intervention group were higher than those in the routing group at three months of care. The range of motion of shoulder anteflexion, posterior extension, abduction, internal rotation, and external rotation in the intervention group was higher than that in the routing group one month after care. The incidence of postoperative complications was 18.18% lower in the intervention group than in the routing group (34.33%; P &lt;0.05). Satisfaction with care was 90.91% higher in the intervention group than in the routing group (78.36%; P &lt;0.05). CONCLUSION Personalized and continuous care can alleviate negative emotions in patients with breast cancer, quicken rehabilitation of limb function, decrease the incidence of complications, and improve living quality and care satisfaction.

Influence of Music Therapy on the Improvement of Perceived Well-Being Indices in Women with Breast Cancer Undergoing Hormonal Treatment

ABSTRACT Background Although there are a growing number of studies investigating the benefits of music therapy interventions with patients diagnosed with cancer, few studies have taken an approach that specifically examines indices of perceived well-being in women with breast cancer. Overcoming these challenges can be an important step in the recovery process. Purpose The purpose of our study was to know the positive influence of responsive music therapy through gong sounds, emitted live, on different areas of well-being of women with breast cancer. Methods Four individual sessions of responsive music therapy with live gong sounds were conducted in which three women (M = 54; SD = 5.57) participated both in the music therapy program and in the completion of the Functional Assessment of Cancer Therapy – Breast (FACT-B) and a semi-structured interview with ad hoc designed questions about perception of qualitative aspects. Results The results showed that the music therapy sessions significantly improved, p = .043 < 0.05, various domains of perceived well-being in women with breast cancer. Discussion This article highlights several key benefits associated with music therapy and various indices of well-being in women with breast cancer, identifies the limitations of the study, and discusses the findings. It is considered necessary to replicate this practice in future studies that include a larger sample and age range over longer follow-up periods. Translation for Health Education Practice The text highlights the importance of considering music therapy as a complementary intervention in comprehensive cancer care programs, which may be relevant to health educators when considering intervention and support approaches for cancer patients. Health education interventions targeting the enhancement of cancer patients’ well-being should incorporate music therapy techniques.

Effects of the "AI-TA" Mobile App With Intelligent Design on Psychological and Related Symptoms of Young Survivors of Breast Cancer: Randomized Controlled Trial.

Young women often face substantial psychological challenges in the initial years following cancer diagnosis, leading to a comparatively lower quality of life than older survivors. While mobile apps have emerged as potential interventions, their effectiveness remains inconclusive due to the diversity in intervention types and variation in follow-up periods. Furthermore, there is a particular dearth of evidence regarding the efficacy of these apps' intelligent features in addressing psychological distress with these apps. This study aims to evaluate the effectiveness of a mobile app with intelligent design called "AI-TA" on cancer-related psychological health and ongoing symptoms with a randomized controlled design. Women aged 18 to 45 years diagnosed with breast cancer were randomly assigned to the intervention or control group. The intervention was AI-TA, which included 2-way web-based follow-up every 2 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses employed repeated measurement analysis of variance. The participants' background features, primary outcomes (psychological distress and frequency, self-efficacy, and social support), and secondary outcomes (quality of life) were measured using multiple instruments at 3 time points (baseline, 1-month intervention, and 3-month intervention). A total of 124 participants were randomly allocated to the control group (n=62, 50%) or intervention group (n=62, 50%). In total, 92.7% (115/124) of the participants completed the intervention. Significant improvements in psychological symptoms (Memorial Symptom Assessment Scale-Short Form) were observed in the ITT group from baseline to 1-month intervention relative to the control group (ITT vs control: 1.17 vs 1.23; P<.001), which persisted at 3-month follow-up (ITT vs control: 0.68 vs 0.91; P<.001). Both the ITT and PP groups exhibited greater improvements in self-efficacy (Cancer Behavior Inventory-Brief Version) than the control group at 1-month (ITT vs PP vs control: 82.83 vs 77.12 vs 65.35; P<.001) and 3-month intervention (ITT vs PP vs control: 92.83 vs 89.30 vs 85.65; P<.001). However, the change in social support (Social Support Rating Scale) did not increase significantly until 3-month intervention (ITT vs control: 50.09 vs 45.10; P=.002) (PP vs control: 49.78 vs 45.10; P<.001). All groups also experienced beneficial effects on quality of life (Functional Assessment of Cancer Therapy-Breast), which persisted at 3-month follow-up (P<.001). The intelligent mobile app AI-TA incorporating intelligent design shows promise for reducing psychological and cancer-related symptoms among young survivors of breast cancer. Chinese Clinical Trial Registry ChiCTR2200058823; https://www.chictr.org.cn/showproj.html?proj=151195.

An evidence-based breathing exercise intervention for chronic pain management in breast cancer survivors: A phase II randomized controlled trial

ObjectiveExplore the preliminary effects of a breathing exercise (BE) intervention on chronic pain among breast cancer survivors. MethodsThis two-parallel-arm, open-label pilot randomized controlled trial recruited 72 breast cancer survivors who were randomly allocated to either the control or intervention group (n = 36 each). Both groups received usual care and a pain information booklet, while the intervention group received 4 weeks of additional BE. The primary clinical outcome was measured using the Brief Pain Inventory (BPI), with secondary clinical outcomes measured by the Hospital Anxiety and Depression Scale (HADS), Quality of Life Patient/Cancer Survivor Version in Chinese (QOLCSV-C), and Functional Assessment of Cancer Therapy- Breast (FACT-B) immediately post-intervention and at 4-week follow-up. Both adjusted and unadjusted Generalized Estimating Equation models were utilized to assess the BE's potential effects, with safety assessed through participant self-report. ResultsSixty-eight participants completed the study. Statistical significance was observed in BPI in both adjusted and unadjusted models at post-intervention and follow-up (p < 0.05). BE demonstrated positive effects on anxiety, depression and quality of life improvement across all measures and timepoints in both adjusted and unadjusted models (p < 0.05). The effect sizes were smaller in the adjusted model. Three mild transient discomforts were reported associated with BE practice including dizziness, tiredness and yawning, without requirement of medical treatment. No severe adverse events occurred. ConclusionThis BE intervention appears effective in alleviating chronic pain, anxiety and depression, and improving quality of life for breast cancer survivors. Fully powered large-scale studies are required to confirm its effects.

Assessing the effectiveness of high frequency repetitive transcranial magnetic stimulation for post-mastectomy pain in breast cancer patients: A randomized controlled trial.

Post-mastectomy pain Syndrome (PMPS), characterized by chronic neuropathic pain stemming from intercostobrachial nerve lesions, presents a formidable clinical challenge. With the incidence of breast cancer surging, effective interventions for PMPS are urgently needed. To address this, we conducted this double-blind, placebo-controlled, randomized clinical trial to study the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) therapy over the motor cortex on pain, quality of life and thermal sensitivity in PMPS patients. We delivered 15 rTMS sessions over three weeks in a cohort of 34 PMPS patients. These patients were allocated randomly to either rTMS therapy or sham therapy groups. Pain assessments, utilizing the Visual Analogue Scale (VAS) and Short Form McGill Pain Questionnaire (SF-MPQ), alongside quality-of-life evaluations through the Functional Assessment of Cancer Therapy-Breast (FACT-B), were recorded before and after the 15 sessions. Additionally, we assessed thermal sensitivity using Quantitative Sensory Testing (QST). Our findings demonstrate the superior efficacy of rTMS therapy (over sham therapy) in reducing VAS and SF-MPQ scores (p < 0.0001), improving physical (p = 0.037), emotional (p = 0.033), and functional well-being (p = 0.020) components of quality of life, as quantified by FACT-B. Our investigation also unveiled marked enhancements in thermal sensitivity within the rTMS therapy group, with statistically significant improvements in cold detection threshold (p = 0.0001), warm detection threshold (p = 0.0033), cold pain threshold (p = 0.0078), and hot pain tolerance threshold (p = 0.0078). The study underscores the profound positive impact of rTMS therapy on pain, quality of life, and thermal sensitivity in patients havingPMPS, opening new avenues for pain management strategies.

A randomized trial of the impact of symptom monitoring using an electronic patient-reported outcome app on health-related quality of life in postmenopausal breast cancer patients receiving adjuvant endocrine therapy.

Electronic patient-reported outcomes (ePRO) monitoring is a useful communication tool for cancer patients and healthcare providers. In this study, we examined the impact of symptom monitoring using an ePRO app on quality of life (QoL) in postmenopausal breast cancer patients receiving adjuvant endocrine therapy. The free app "Welby My Carte ONC" was used in the study. Patients with breast cancer starting adjuvant endocrine therapy were randomly assigned in a 1:1 ratio to ePRO monitoring (ONC) and control groups. The ONC group reported five symptoms extracted from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) (insomnia, joint pain, headache, anxiety, and hot flashes) weekly for 3months through the app. Reported symptoms were shared with medical personnel. When serious symptoms were reported, these personnel ascertained the patient's health status and provided advice over the phone. The primary endpoint was QoL measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 3months from enrollment. Differences between groups were tested using analysis of covariance. The study included 125 subjects with mean age of 64years in the ONC group (n = 61) and 63years in the control group (n = 64). In the ONC group, the response rate to PRO-CTCAE was about 70% or higher until week 10. The item missing rate was 0. The ONC group reported more symptoms related to joint pain and insomnia. The difference in FACT-B total score between the groups was -1.55 (95% confidence interval: -5.91, 2.81), indicating no significant difference. Symptom monitoring using ePRO early after initiation of adjuvant endocrine therapy after surgery did not improve QoL of breast cancer patients.

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Abstract PO2-11-07: Early Integration of Exercise into Breast Cancer Care: The MSK Healthy Living Program

Abstract Background: In patients with early-stage breast cancer, quality of life (QoL) worsens within 3-6 months following diagnosis. Physical activity (PA) can mitigate the adverse effects of treatment and improve QoL, and low PA level is associated with cancer recurrence and mortality. However, PA interventions are not included in standard cancer care. Early intervention to increase PA levels may improve QoL during active cancer therapy. The Healthy Living Program (HLP) at Memorial Sloan Kettering Cancer Center (MSK) is a lifestyle and survivorship program that engages early-stage breast cancer patients at the time of diagnosis using lifestyle risk stratification and matched referrals. We investigated whether early exercise intervention through the MSK HLP impacts QoL within the first months after cancer diagnosis. Methods: At the time of diagnosis, patients complete a lifestyle questionnaire (LQ), which is a composite of validated instruments, including the Godin Leisure Time Exercise Questionnaire (GLTEQ). Patients not meeting PA guidelines per the GLTEQ are offered a referral to an exercise physiologist (EP). The EP creates an individualized, home-based exercise program using the FITT Principle (Frequency, Intensity, Time, and Type). Patients meet with the EP every 4 weeks for 16 weeks; if exercise recommendations continue to be unmet, the program is extended. The Functional Assessment of Cancer Therapy-Breast (FACT-B) and 36-Item Short Form Survey Instrument (SF-36) were completed at baseline and the 16-week follow-up. Results: 252 patients enrolled between April 2020 – February 2023, of whom 92 volunteered to complete the QoL assessments. Median age was 53 years [range 23-84]; 12/252 (13.0%) of patients had ductal carcinoma in situ, 60/252 (65.2%) had Stage 1 disease, 17/252 (18.5%) had Stage 2 disease, and 3/252 (3.1%) had Stage 3 disease. 29/252 (31.5%) received chemotherapy, 62/252 (67.4%) received radiation, and 79/252 (85.9%) received hormone therapy. The mean baseline FACT scores were FACT-B: 116, FACT-G: 87, and FACT-B Trial Outcome Index (TOI): 73. At the 16-week follow-up, all QOL scores remained stable from baseline (means FACT-B: 118, FACT-G: 89, and TOI: 75). Improvements were observed among the subscales of the SF-36 from baseline to follow-up. The largest improvements were observed in physical and emotional role function scores, with 22% and 13% improvements from baseline to follow-up, respectively. Conclusions: A clinically implemented exercise intervention embedded in standard of care prevented decreases in QoL and improved physical and emotional functioning during the initial course of adjuvant breast cancer therapy. These findings support early implementation of lifestyle modification after a breast cancer diagnosis. Citation Format: Kylie Rowed, Sherry Shen, Andrea Smith, Bridget Kelly, Rocco Magnoli, Stacie Corcoran, Melissa Emerzian, Cynthia Cruz, Erica Salehi, Cara Anselmo, Mark Robson, Neil Iyengar. Early Integration of Exercise into Breast Cancer Care: The MSK Healthy Living Program [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-11-07.

Abstract PS02-09: Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial

Abstract Background: Follow-up after breast cancer with regular specialist-led visits has failed to prove superiority over other strategies in terms of recurrence detection and survival, but it is still a cornerstone in breast cancer follow-up in many healthcare systems. Follow-up provided by the general practitioner or a specialist nurse has been reported more cost-effective and non-inferior in terms of patient-reported health-related quality of life (HRQoL) and in meeting the needs of breast cancer survivors. However, no follow-up strategies have demonstrated indisputable superiority over other strategies. Methods: In this randomized controlled trial (MyHealth), patients who recently completed surgery, and chemo-/radiotherapy if indicated, for stage I–II breast cancer were randomly assigned to intervention or control follow-up at Zealand University Hospital, Denmark. The nurse-led intervention comprised three to five individual self-management sessions during the first six months, and regular reporting of symptoms with nurse navigation to relevant healthcare services during three years of follow-up. The control comprised outpatient visits with oncologist every six months for three years. The primary outcome was breast cancer-specific HRQoL measured by the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) summary score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) two years after randomization. Secondary outcomes were fear of recurrence, anxiety, depression, and healthcare utilization. Results: From January 2017 to January 2019, 503 patients were randomly assigned to intervention (n=251) or control (n=252) follow-up. At two years, patients in the intervention group reported a significantly higher HRQoL (mean 75·69 (SD 12·27)) than patients in the control group (mean 71·26 (SD 14·08)), a mean difference of 5·05 (95% CI; 3·30–6·79), which is considered clinically relevant. The intervention group also reported significantly less fear of recurrence, anxiety, and depression as shown in Table 1. Furthermore, patients in the intervention group had fewer physician consultations but more nurse contacts, and an unchanged diagnostic imaging pattern as shown in Table 2. The effect on all outcomes was stable through three years of follow up. Conclusions: The MyHealth study suggests a new strategy for follow-up after early breast cancer providing significant improvements in HRQoL, fear of recurrence, anxiety, and depression without inflicting extra expenses to the healthcare system. (Funded by the Danish Cancer Society, Region Zealand and Copenhagen University Hospital; Clinicaltrials.gov number; NCT02949167.) Table 1: Outcome findings by study group at baseline, 6, 12, 24, and 36 months Data are mean (SD) unless otherwise stated. The effect estimates are based on the mixed model assuming no difference between groups at baseline. The QoL and fear of recurrence variables are continuous, and the estimates describe the mean difference in score between patients in the two groups. For anxiety and depression, data were zero-inflated. These estimates describe the exponential coefficients of anxiety and depression scores in the intervention group compared to the control group. Cohen’s d is a measure of effect size, and interpreted as small for Cohen’s d = 0·2, medium for Cohen’s d = 0·5, and large for Cohen’s d = 0·8 Table 2: Number of contacts and diagnostic imaging examinations during the first three years of follow-up by study group Data are numbers and mean (SD) per patient during the first three years of follow-up. 1 Most telephone consultations were scheduled as outpatient visits according to the protocol, but changed to telephone consultations due to the COVID-19 pandemic Citation Format: Lena Saltbæk, Pernille Bidstrup, Randi Karlsen, Beverley Høeg, Trine Horsboel, Federica Belmonte, Elisabeth Andersen, Vibeke Zoffmann, Anne Friberg, Mads Svendsen, Helle Christensen, Vesna Glavicic, Dorte Nielsen, Susanne Dalton, Christoffer Johansen. Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-09.

Abstract PO3-11-03: A Randomized Controlled Trial to Assess the Benefit of Art &amp; Music Therapy on Quality of Life in Patient with Breast Cancer

Abstract Introduction: Quality of life (QoL) in oncology captures the well-being of a patient and is considered a significant outcome criterion. Breast cancer (BC) is the most diagnosed cancer in women, however, standardizing integrative therapies to alleviate the burden of cancer and improve QoL is still an unmet need. Art and music therapy might mitigate psychological and emotional distress. We sought to evaluate their efficacy compared to control among patients with BC during or after active therapy. Methods: Seventy-six treated patients with Stages I-III BC were randomly assigned to art, music therapy, or routine oncology care standard of care arm (SOC) for 3 months and received two sessions per month by a licensed therapist (including in-person/virtual and group sessions). The primary outcome was an improvement in QoL measured by the Functional Assessment of Cancer Therapy–Breast (FACT-B) questionnaire and secondary outcomes included: cognitive function measured by Functional Assessment of Cancer Therapy–Cognition (FACT-Cog), response to a 4-component Cleveland Clinic Visual Analog Scale (CCVAS), indicators of anxiety and depression assessed by the Generalized Anxiety Disorder-7 item (GAD-7) and Patient Health Questionnaire-9 item (PHQ-9). All questionnaires were assessed at baseline, 30, 90, and 180 days. Statistical considerations included stratified randomization, and a mean difference in 15 points between either of the interventions. SOC arm was considered relevant at the 3-month mark. Mean improvement within groups was performed using paired t-tests whereas independent t-tests were used to evaluate mean improvement between interventions (1 or 2 vs. SOC arm). All analyses were performed using SPSS version 26 (IBM, Armonk, NY). Results: Forty-five participants completed the study to date and were included in the interim analysis. Median age was 58 (57-59), white race (51.1%), patients on active treatment (45%), art therapy group (n=16), music therapy (n=15) and standard of care (n=14). Significant improvement was noted in the art therapy arm at 3 months in FACT-B physical well-being (p=0.04), functional well-being (p=0.008) domains as well as GAD-7 (p=0.003), PHQ-9 (p=0.04) and FACT-Cog section “impact on quality of life” (p=0.03). At 6 months, the art therapy arm demonstrated lower scores in the CCVAS questionnaire total score, emotional distress (p=0.01) and anxiety (p=0.004) scales. Music therapy participants reported a significant improvement only in GAD-7 index(p=0.04) at 3 and 6 months compared to SOC. No significant difference was found between art and music therapy arms. Conclusion: Art therapy patients exhibited significant improvement in overall QoL (including anxiety, depression, improvement in cognitive function) and 4-scale CCVAS (emotional distress, anxiety, depression, and pain). Music therapy improved anxiety scores (GAD-7). Art and music therapy should be considered in the care of patients to manage cancer associated distress and improve their quality of life. Table 1. Comparison of test changes from 3 months to baseline within groups Table 2. Comparison of test changes from 6 months to baseline within groups Citation Format: Maria Herran, Mohamed Mohanna, Saad Sabbagh, Barbara Dominguez, Kaylee Sarna, Rachel Upton-Rice, Angie Burdine, Zeina Nahleh. A Randomized Controlled Trial to Assess the Benefit of Art &amp; Music Therapy on Quality of Life in Patient with Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-11-03.

The impact of fear of cancer recurrence on the quality of life of breast cancer patients: A longitudinal study of the mediation effect of cortisol and hope

ObjectiveThis longitudinal study sought to explore the impact of cortisol and hope levels on Fear of Cancer Recurrence (FCR) and Quality of Life (QOL) in a cohort of 552 breast cancer patients from three centers in Wuhan City. MethodA longitudinal study involving 552 breast cancer patients from three centers in Wuhan City utilized Chinese versions of the Fear of Progression Questionnaire-Short Form (FoP-Q-SF), the Herth Hope Index (HHI), and the Functional Assessment of Cancer Therapy-Breast (FACT-B) scale. Cortisol levels were measured thrice daily, and data was collected longitudinally three times. Data analysis was conducted using SPSS 26.0 and Mplus 8.3, employing a longitudinal path model constructed via the cross-lagged method. ResultsThe results showed there were significant correlations between FCR, cortisol levels, and QOL at different time points. A significant mediating model was found with outcomes related to hope levels. Specifically, FCR predicted a decrease in hope levels (β = −0.163, p < 0.001), which in turn led to a decrease in overall QOL (β = −0.078, p < 0.001), with a mediation effect accounting for 10.34%. Although there were correlations between FCR, cortisol levels, and QOL at different time points, further analysis revealed that cortisol levels did not exhibit a mediating effect between the two (95% confidence interval: −0.002 to 0.001). ConclusionThis study demonstrated there were significant correlations among FCR, QOL, and hope levels. Considering hope as a crucial mediator between FCR and QOL, potential intervention strategies for optimizing the QOL of breast cancer patients are proposed.

Perceived control, self-management efficacy, and quality of life in patients treated with radiation therapy for breast cancer: a longitudinal study.

This longitudinal study aims to examine the present state of perceived control, self-management efficacy, and overall quality of life (QoL) in patients with breast cancer undergoing radiotherapy, and gain insight into the dynamic trends and factors that influence the quality of life experienced by patients during the course of radiotherapy. Participants completed the Cancer Experience and Efficacy Scale (CEES), Strategies Used by People to Promote Health (SUPPH), and Functional Assessment of Cancer Therapy- Breast (FACT-B). The data was analyzed using the software SPSS26.0. Repeated measures analysis of variance (ANOVA) and mixed-effects linear models were used to analyze trends in perceived control, self-management efficacy, and QoL at three-time points, as well as factors affecting QoL during radiotherapy. Perceived control and self-management efficacy were associated with QoL over the course of the radiotherapy. Self-management efficacy (β = 0.30, P < 0.001), presence of chemotherapy (β = 18.33, P = 0.024), and duration of illness (β = 2.25, P = 0.028) had a positive effect on the change in QoL, while time (β = - 2.95, P < 0.001), cancer experience (β = - 0.46, P < 0.001), and type of medical insurance (β = - 2.77, P = 0.021) had the negative effect on the change in QoL. The QoL, perceived control, and self-efficacy of patients with breast cancer show dynamic changes during radiotherapy. The higher the self-efficacy, the better the QoL, and the worse the QoL when the sense of disease control is poor. At the same time, more attention should be paid to the QoL of breast cancer radiotherapy patients with a long course of the disease, receiving chemotherapy, and different medical payment methods.

Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial.

Follow-up after breast cancer with regular visits has failed to detect recurrences, be cost-effective, and address patient needs. MyHealth is a phase III randomized controlled trial (ClinicalTrials.gov identifier: NCT02949167). Patients, who recently completed primary treatment for stage I-II breast cancer, were randomly assigned in variable block sizes and stratified by age and human epidermal growth factor receptor 2 status to intervention or control follow-up. The nurse-led intervention comprised three to five individual self-management sessions, regular reporting of symptoms, and navigation to health care services. The control follow-up comprised regular outpatient visits with the physician. The primary outcome was breast cancer-specific quality of life (QoL) measured by the Trial Outcome Index-Physical/Functional/Breast summary score of the Functional Assessment of Cancer Therapy-Breast 2 years after random assignment. Secondary outcomes were fear of recurrence, anxiety, depression, and health care utilization. Analyses were intention-to-treat and P values were two-sided with 95% confidence level set at 0.005 because of multiple comparisons. Among 1,101 eligible patients, 875 were invited and 503 were randomly assigned to control (n = 252) or intervention (n = 251) follow-up. At 2 years, patients in the intervention group reported a significantly and clinically relevant higher QoL (mean, 75.69 [standard deviation [SD], 12.27]) than patients in the control group (71.26 [SD, 14.08]), with a mean difference of 5.05 (95% CI, 3.30 to 6.79; P < .001). The intervention group reported significantly less fear of recurrence, anxiety, and depression; they had fewer physician consultations but more nurse contacts and an unchanged diagnostic imaging pattern. The effect on all outcomes was stable through a 3-year follow-up. The MyHealth study suggested a new strategy for follow-up after early breast cancer as it provided significant improvements in QoL.