Symptom Interference Research Articles

Oncofertility to Evidence-Based Practice: Changes in Fertility Intention and Symptom Burden in Reproductive-Age Women With Breast Cancer.

Infertility is negatively related to the quality of life in reproductive-age women with breast cancer. The nurses who care for these patients lack a comprehensive understanding of the changes in fertility intention that patients undergo from the time of cancer diagnosis, throughout treatment, and after treatment. A fertility intention assessment is the first step in discerning the patient's ideas toward future pregnancy. This study examined the changes in fertility intention and symptom burden in reproductive-age women with breast cancer before, during, and after treatment. We also explored predictors of fertility intention among the women. The study was guided by the theory of planned behavior. A longitudinal and observational study was conducted with 151 women with breast cancer who were treated at a teaching hospital in Taipei. The participants were interviewed using a structured questionnaire before, during, and after chemotherapy from July 2016 to March 2018. Fertility intention was assessed using the Fertility Intention Scale. The M.D. Anderson Symptom Inventory-Taiwanese version was used to measure the symptom burden. The generalized linear mixed model was used for multivariate analysis. Patients had significantly lower scores for fertility intention after treatment than before treatment. The study patients had substantially worse symptom burden during treatment than before or after treatment. Symptom burden scores, especially for symptom interference, correlated significantly with fertility intention. A higher Fertility Intention Scale score was significantly associated with younger age. Fertility intention decreased over time in women with breast cancer. Understanding fertility intention and controlling symptom burden throughout the course of treatment and beyond might help nurses provide better care for preserving fertility and maintaining fertility options for these women with breast cancer.

Cognitive behavior therapy for menopausal symptoms (CBT-Meno): a randomized controlled trial.

To evaluate the effectiveness of cognitive behavioral therapy for menopausal symptoms (CBT-Meno) compared with a waitlist condition (no active intervention). A randomized controlled trial was conducted with 71 perimenopausal or postmenopausal women who were seeking treatment for menopausal symptoms. Blind assessments were conducted at baseline, 12 weeks postbaseline, and 3 months post-treatment. An intention-to-treat analysis was conducted. CBT-Meno sessions included psychoeducation, and cognitive and behavioral strategies for vasomotor and depressive symptoms, anxiety, sleep difficulties, and sexual concerns. Primary outcomes were scores on the Hot Flash Related Daily Interference Scale (HFRDIS) and Beck Depression Inventory (BDI-II). Secondary outcomes were scores assessing vasomotor and sexual concerns on the Greene Climacteric Scale (GCS-vm, GCS-sex), the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Pittsburgh Sleep Quality Index (PSQI), and the Female Sexual Function Index (FSFI). There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS; P < 0.001, ηP = 0.21) and "bothersomeness" (GCS-vm; P = 0.04, ηP = 0.06), depressive symptoms (BDI-II; P = 0.001, ηP = 0.15), sleep difficulties (PSQI; P = 0.001, ηP = 0.17), and sexual concerns (GCS-sex; P = 0.03, ηP = 0.07). These results were found even when controlling for menopausal staging and medication use. Gains were maintained at 3 months post-treatment. CBT-Meno was particularly effective in improving self-reported vasomotor symptoms, depressive symptoms, sleep difficulties, and sexual concerns. Although future studies will be needed to confirm the impact of CBT-Meno on anxiety symptoms, these results suggest that this protocol is effective in targeting commonly reported menopausal symptoms. : Video Summary: Supplemental Digiatl Content 1, http://links.lww.com/MENO/A416.

Patient-reported outcomes (PROs) in IMmotion150: Atezolizumab (atezo) alone or with bevacizumab (bev) versus sunitinib (sun) in first-line metastatic renal cell carcinoma (mRCC).

4515 Background: The phase 2 IMmotion150 study showed improved PFS with atezo + bev vs sun in patients (pts) whose tumors were PD-L1+ and corroborated the activity of atezo monotherapy in previously untreated mRCC. This study offers an opportunity to evaluate PROs with immunotherapy and VEGF-directed therapy alone and in combination. Methods: Pts randomized to atezo 1200 mg IV q3w alone or with bev 15 mg/kg IV q3w, or sun 50 mg po qd for 4 wk on/2 wk off completed the MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) q3w of each 6-wk cycle until progression (RECIST 1.1). Time to deterioration (TTD; first ≥ 2-point score increase over baseline [BL]) and change from BL (effect size [ES] ≥ 0.2 suggests a clinically important difference vs sun) in MDASI symptom severity and interference and BFI fatigue severity and interference scores are reported for all-comers. Results: Completion rates were &gt; 90% at BL and ≥ 80% at most visits across arms. BL PRO scores indicating mild symptoms and interference were similar across arms. Delayed TTD of symptom severity and interference with daily life was seen with atezo vs sun and atezo + bev vs sun and was longest with atezo alone (Table). Pts reported milder symptoms and less interference during the first 6 cycles with atezo vs sun: ES mean (range) was 0.36 (0.07-0.68) for core symptom severity and 0.36 (0.04-0.83) for symptom interference. The 5 worst pt-reported symptoms during tx (dry mouth, fatigue, rash, drowsiness, lack of appetite) were all in the sun arm; all 16 symptoms measured were milder with atezo vs sun. Conclusions: PROs suggest that atezo alone or with bev maintained daily function with minimal symptom interference vs sun. Clinical activity, safety and PRO data for atezo support its investigation in adjuvant tx of high-risk RCC pts (IMmotion010; NCT03024996). Clinical trial information: NCT01984242. [Table: see text]

Oncology Associated Symptoms and Individualized strategies (OASIS): Precision symptoms management for rural patients with advanced cancer.

e23155 Background: Rural cancer patients have limited access to symptom management specialists. OASIS is an 8-week, web-based intervention addressing this access gap by providing the right symptom management to the right patients at the right time. This feasibility study seeks to describe recruitment and retention patterns and evaluate symptom severity, distress, and interference at 4, 8, and 12 weeks. Methods: Eligibility included: advanced cancer diagnosis, &gt; 18 years old, and living in small town or rural area. Reasons for non-enrollment and dropout were collected. Descriptive statistics were calculated to evaluate recruitment and retention rates along with symptom severity and interference at each time point. The mean severity and distress scores using the 0-10 NRS of the five symptoms with the highest rating was computed for each time point (i.e., baseline, week 4, and week 8). By averaging the five highest rated symptoms, we evaluated the worst symptoms the individual is experiencing at each data point. Results: Fifty-nine people were approached about the study over 18 months, 38 people signed consents, 12 dropped before completing baseline questionnaires, and 9 completed baseline questionnaires but did not start the intervention. Seventeen people completed baseline questionnaires and started the intervention. The recruitment rate was 66%, the retention rates were 50% and 33% at 4 and 12 weeks.Reasons for drop out included lack of bothersome symptoms, too busy, and generally overwhelmed. Mean age of sample was 62 years and majority men (62.5%). Fatigue (M = 6.4), drowsiness (M = 5.4), numbness/tingling (M = 4.4), and sleep disturbance (M = 4.4) were the most severe symptoms at baseline. Mean symptom severity was M = 3.03 and mean interference was M = 2.53 at baseline. For participants who received the full OASIS-WN intervention, between baseline and week 8, the mean interference rating decreased by 1.6±2.1 points (p = .019), mean severity and distress ratings for the five worst symptoms decreased by 1.72±1.72 (p = .004) and 2.2±2.4 (p = .006), respectively. Conclusions: Symptom severity, distress, and interference improved for participants who received the full intervention. Reasons for early drop out suggest symptom management ought to be provided when the situation is optimal for learning. Future research will evaluate the efficacy of OASIS.

NRG Oncology CC001: A phase III trial of hippocampal avoidance (HA) in addition to whole-brain radiotherapy (WBRT) plus memantine to preserve neurocognitive function (NCF) in patients with brain metastases (BM).

2009 Background: NRG CC001, a phase III trial of WBRT plus memantine (WBRT+M) with or without HA, sought to evaluate the neuro-protective effects of lowering the hippocampal radiation dose. Methods: Patients (pts) with BM were stratified by RPA class and prior radiosurgery/surgery and randomized to WBRT+M or HA-WBRT+M (30Gy/10 fractions). Standardized NCF tests were performed at baseline, 2, 4, 6, and 12 months (mos). The primary endpoint was NCF failure, defined as decline using the reliable change index on Hopkins Verbal Learning Test-Revised, Trail Making Test, or Controlled Oral Word Association. Cumulative incidence estimated NCF failure (death without NCF failure was competing risk); between-arms differences tested using Gray’s test. Deterioration at each collection time point was tested using a chi-square test. Patient-reported symptoms were assessed using the MD Anderson Symptom Inventory Brain Tumor module and analyzed using mixed effects models and t-tests. Results: From 7/2016 to 3/2018, 518 pts were randomized. Median follow-up was 7.9 mos. HA-WBRT+M was associated with lower NCF failure risk (adjusted hazard ratio (HR) = 0.74, p = 0.02) due to lower risk of deterioration in executive function at 4 mos (p = 0.01) and encoding (p = 0.049) and consolidation (p = 0.02) at 6 mos. Age≤61 predicted lower NCF failure risk (HR = 0.60, p = 0.0002); non-significant test for interaction indicated independent effects of HA and age. Patient-reported fatigue (p = 0.036), difficulty speaking (p = 0.049) and problems remembering things (p = 0.013) at 6 mos favored the HA-WBRT+M arm. Imputation models accounting for missing data also favored the HA-WBRT+M arm for patient-reported cognition (p = 0.011) and symptom interference (p = 0.008) at 6 mos. Treatment arms did not differ in toxicity, overall survival, or intracranial progression. Conclusions: HA during WBRT+M for BM better preserves NCF and patient-reported symptoms, while achieving similar intracranial control and survival. Supported by grants UG1CA189867 (NCORP), U10CA180868 (NRG Oncology Operations), DCP from the National Cancer Institute. Clinical trial information: NCT02360215.

Patient-reported outcomes during hospitalization for patients with late discharge after an open surgery for GYN tumors.

e18078 Background: Using patient-reported outcomes (PRO) in perioperative care is increasingly common in patients undergoing major surgery. Few reports relate the patient’s symptomatic status using validated PROs during hospitalization with other outcomes, such as length of stay (LOS). Methods: Patients with GYN tumors scheduled for open surgery at MD Anderson Cancer Center were recruited prospectively. The MD Anderson Symptom Inventory gynecology perioperative care module (MDASI-PeriOp-GYN) was used to assess symptoms daily during hospitalization. Longitudinal analysis compared patient’s PROs between groups who were discharged within and beyond the median LOS. Results: From Feb 2018–Dec 2018, 83 patients were evaluable. The median LOS was 3 days. 70% of patients were discharged within 3 days, and 30% were hospitalized longer (defined as late discharge group, range 4-10 days). The median LOS for the two groups was 5.64 vs. 2.41 days, P &lt; .0001. Compared to patients who were discharged within 3 days, late discharge patients had longer surgical time (310 min vs. 209 min, P &lt; .0001), and greater operative blood loss (668mL vs. 289 mL, P &lt; .001). Additionally, more patients in the late discharge group had a worse performance status (ECOG PS 2-3: 24% vs. 3.5%, P &lt; .05), and higher comorbidity (Charlson comorbidity Index &gt; 1: 92% vs. 69%, P &lt; .05), and more used opioids within 6 month pre-surgery (16% vs. 1.7%, P &lt; .05). For all patients, the 5 worst symptoms during the first 3 hospital days were pain, fatigue, drowsiness, dry mouth, bloating. Late discharge patients reported significant more severe pain, distress, dry mouth, and interference with walking during the first 3 days post-surgery (all P &lt; .05). Conclusions: Despite all patients undergoing standardized perioperative care on an Enhanced Recovery pathway, this study demonstrates how baseline and intraoperative factors are associated with longer LOS and more severe symptom burden, especially pain and interference with walking.

Recovery of symptom burden and functioning for patients with late discharge after an open surgery for GYN tumors.

e18083 Background: The symptom burden and functional recovery of patients after hospital discharge is important to understand in order to provide more patient centered care. This study evaluated longitudinal quantitative patient-reported outcome (PRO) data using a validated PRO symptom and functional interference measure after hospital discharge from open gynecologic surgery. Methods: Patients with GYN tumors scheduled for laparotomy at MD Anderson Cancer Center were recruited prospectively. The MD Anderson Symptom Inventory gynecology perioperative care module (MDASI-PeriOp-GYN) was used to assess symptoms post discharge on Day 3, 7, and weekly up to 6 weeks. Median survival time and log-rank test was used for comparing time to return to no or mild level (≤3 in a 0-10 scale) of symptoms during the post discharge period between groups who discharged within and beyond the median length of stay (LOS) days. Results: From Feb 2018–Dec 2018, 83 patients were evaluable. The median LOS was 3 days. Compared to patients who were discharged within 3 days (70% of sample), 30% patients were discharged after 3 days after surgery (range of 4-10 days). Except distress, all other PROs on MDASI-PeriOp-GYN were not significantly different between the two groups on the day of discharge. However, those late discharged patients had significantly delayed recovery on fatigue (median recovery time &gt; 56 days vs. 17 days), dry mouth (10 days vs. 6 days) (both P&lt; .01), and drowsiness (12 days vs. 6 days, P&lt; .05). The recovery of physical functioning (MDASI general activity interference item) was prolonged among late discharged patients compared to patients who were discharge within 3 days ( &gt; 56 days vs. 30 days, P&lt; .01). Conclusions: Even though all patients were under a standardized Enhanced Recovery Program, about 30% of patients post GYN open surgery were discharged beyond the median LOS. Patients in this group continued to have delayed recovery after hospital discharge as evidenced by persistent fatigue and slower return of physical functioning. Implementation of post-discharge PROs may help identify patients at risk for prolonged recovery and help triage patients to more intensive supportive care.

Atezolizumab (atezo) + bevacizumab (bev) versus sunitinib (sun) in pts with untreated metastatic renal cell carcinoma (mRCC) and sarcomatoid (sarc) histology: IMmotion151 subgroup analysis.

4512 Background: In the Phase 3 IMmotion151 trial, atezo + bev showed improved PFS vs sun in untreated mRCC pts expressing PD-L1. Here we report results of a prespecified subgroup analysis in pts whose tumors have sarc histology, an independent predictor of poor survival. Methods: Pts were randomized to receive atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w or sun 50 mg po qd for 4w on, 2w off. Coprimary endpoints were reported previously (Motzer ASCO GU 2018). Secondary endpoints included INV-PFS and OS in sarc pts and are shown here with INV-ORR, safety, PRO and biomarker data. Results: 142 randomized pts (16%) from IMmotion151 had tumors with any component of sarc histology; mPFS was 8.3 vs 5.3 mo with atezo + bev vs sun and mOS was NR vs 15.0 mo, respectively (see Table for PD-L1+). ORR was 49% vs 14% and CR rate was 10% vs 3% in the atezo + bev vs sun arms. Grade 3-4 AEs occurred in 27 pts (40%) with atezo + bev and 34 (49%) with sun. Using the MDASI scale, sarc pts reported longer median time to deterioration (TTD) of symptom interference with daily activities with atezo + bev vs sun (11.3 vs 4.9 mo). Prevalence of AngiogenesisHigh gene expression (GE) signature subset was lower (34% vs 65%) and T-effectorHigh GE subset was higher (54% vs 40%) in sarc vs non-sarc tumors. PD-L1+ disease was more common in sarc vs non-sarc tumors (63% vs 39%). Conclusions: mRCC pts with sarc histology had longer OS and PFS and a higher ORR/CR rate when treated with atezo + bev vs sun, regardless of PD-L1 status. Biomarker data support a biological correlate for the increased responsiveness to atezo + bev in sarc pts. Clinical trial information: NCT02420821. [Table: see text]

Su1499 – Symptom Prevalence and Interference in End Stage Liver Disease

Su1499 – Symptom Prevalence and Interference in End Stage Liver Disease

Minocycline for symptom reduction during radiation therapy for head and neck cancer: a randomized clinical trial.

Local/systemic symptoms during cancer therapy may be exacerbated by dysregulated inflammation and its downstream toxic effects. Minocycline can suppress proinflammatory cytokine release; therefore, we investigated its potential to reduce patient-reported symptom severity during radiotherapy (RT) for head and neck cancer (HNC). Eligible patients for this blinded, placebo-controlled trial were adults with T0-3, N-any, and M0 HNC receiving single-modality RT. Participants were randomized 1:1 to either minocycline (200mg/day) or placebo during RT. The primary endpoint was the area under the curve (AUC) of 5 prespecified symptoms (pain, fatigue, disturbed sleep, poor appetite, difficulty swallowing/chewing) during RT, assessed with the MD Anderson Symptom Inventory for HNC (MDASI-HN). We analyzed data from 20 evaluable patients per arm. Overall, 75% had oropharyngeal cancer and 78% were male. No grade 3+ adverse events potentially related to study medication were observed. Two minocycline patients required a feeding tube during RT vs 5 placebo patients (P = 0.21). The average daily AUC during RT for the 5 MDASI-HN symptoms was 3.1 (SD = 1.0) for minocycline and 3.7 (SD = 1.7) for placebo (P = 0.16); the 0.37 effect size was less than our 0.70 target. AUC comparisons for several individual symptoms and symptom interference favored minocycline but were not statistically significant. The greatest numerical differences occurred for systemic symptoms, larger toward treatment end, and in early post-RT recovery. Minocycline was feasible, well tolerated, and achieved a positive signal toward reducing patient-reported symptom severity during RT for HNC, particularly for systemic symptoms. This justifies additional study and informs future trial design.

Stigma and Quality of Life in Patients With Advanced Lung Cancer

To identify groups of participants with high and low levels of stigma and to examine the influence of stigma on social support, social constraints, symptom severity, symptom interference, and quality of life (QOL). 62 individuals with lung cancer were identified and recruited from a comprehensive cancer center in the southeastern United States. Participants completed a questionnaire that included demographic information and measures of stigma, symptom severity and interference, social support, social constraints, and QOL. IBM SPSS Statistics TwoStep Cluster Analysis was used to identify high- and low-stigma groups. Independent sample t tests were used to compare differences between the groups. 22 participants had a high level of stigma; they had significantly higher symptom severity on feeling distressed, problems remembering things, and feeling sad, and greater symptom interference related to mood, relations with others, and enjoyment of life. Participants also had significantly higher levels of social support and lower social constraints. Stigma was significantly related to lower levels of QOL. Nurses should be aware that stigma may influence various factors throughout the disease trajectory; they can privately assess individuals with lung cancer for access to social supports, feelings of stigma, and QOL, and make appropriate referrals as needed.

SUN-LB078 Biochemically Controlled Acromegaly Patients on a Stable Dose of Injectable Somatostatin Analogues in Routine Clinical Practice Still Remain Symptomatic: Preliminary Results from Endocrinology Health Care Professionals

Aim To understand how endocrinology health care professionals’ (HCP) perceive their acromegaly patients (pts) treatment outcomes Methods We undertook a two-staged study in which US acromegaly pts on a stable dose of SSAs for the past year completed an online survey. Their treating HCP was interviewed to provide their perception of the individual pt that completed the survey focusing on biochemical control; symptom (sx) control and interference; adverse reactions; general health; and sx interference, treatment satisfaction, bother, and convenience from the Acro-TSQ. (One HCP was a DNP; all others were endocrinologists.) The HCP was requested to have the medical records for that individual pt available during the interview, and completed the questions based on his/her perception of the pt’s outcomes. Preliminary data from the subset of 30 HCPs treating pts that were well-controlled biochemically (IGF-1≤1xULN) of the 39 interviewed were analyzed descriptively. Analyses of concordance between pts and HCPs are reported elsewhere. Results 39 HCPs (mean time in practice = 20 + 12 yrs; 64% in academic setting) were enrolled. Of those, a subset of 30 HCPs (77%) treated pts that were well controlled biochemically. These 30 HCPs reported that pts experienced moderate or severe acromegaly-related sxs, despite being biochemically controlled and receiving a stable dose of SSA. Specifically, HCPs reported that the majority of their pts experienced fatigue/weakness/feeling tired (87%), joint pain (70%), headaches (60%) and soft tissue swelling (43%). Forgetfulness/short-term memory loss/feeling in a daze, referred to as “acro-fog,” was reported by 33% of HCPs. Quite often, the HCP was not able to describe the temporal pattern (constant or at different periods throughout the injection interval) for their pts’ sxs. HCPs reported that only 27% of their pts were symptomatically well controlled. Mean HCPs’ ratings of pts’ general health, on a 0 to 100 scale with 0 = worst and 100 = best health imaginable was 73 + 17 (range = 25-95). When HCPs were asked to provide input on what treatment aspect their pt would like to improve, 50% stated that pts wanted better symptom control. The mean domain score for sx interference with daily life from the Acro-TSQ was 57 + 27, with 0 = most and 100 = least interference. Conclusions This is the first study to assess HCP perceptions of their individual patient’s outcomes. HCPs were aware of the significant sx burden and impact in general health and daily life experienced by their biochemically-controlled pts. The fact that treatment was kept stable, despite having active acromegaly sxs, suggests an unmet need in this population. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

What symptoms are important to patients? Developing a symptom burden measure for women with breast cancer.

The American Cancer Society predicted that 266,120 women would be diagnosed with breast cancer in 2018. Women experience significant symptom burden in response to tumor and treatment-related adverse effects, particularly in advanced disease. Use of valid and reliable patient-reported outcomes (PRO) symptom measures may assist clinicians in systematically monitoring and managing symptoms. The MD Anderson Symptom Inventory (MDASI) is a brief PRO measure of cancer symptom burden; specific symptoms can be added to the core symptoms to produce disease- and treatment-specific modules. The purpose of this study was to describe the patient symptom experience, define the content domain, and generate items for a breast cancer-specific MDASI module for measuring symptom burden in women with breast cancer. Women with breast cancer were qualitatively interviewed about their experiences of disease and treatment. Descriptive exploratory analysis identified symptoms and symptom interference to define the symptom burden of breast cancer. An expert panel rated the relevance of the identified symptoms to patients with breast cancer. A conceptual model of breast cancer symptom burden was developed from interviews with 36 women (mean age of 57.9years, 86.1% had stages I-III, and 52.8% were on chemotherapy and/or radiation therapy) across the breast cancer disease and treatment trajectory. Thirty-six symptoms and 6 interference categories were identified. Symptoms specific to treatment modalities and breast cancer met the criteria for inclusion in the provisional instrument for psychometric testing. We generated an instrument with content validity for measuring symptom burden specific to women with breast cancer.

HSR19-112: Qualitative Development of a Patient-Reported Outcome Measure of Symptom Burden in Breast Cancer

Background: The use of disease-specific patient-reported outcomes (PROs) is critical for facilitating individualized symptom monitoring and improving cancer patient outcomes. The MD Anderson Symptom Inventory (MDASI) is a PRO measure of symptom burden. The purpose of this study was to describe the patient experience and define the content domain for the MDASI module specific to breast cancer (MDASI-Br). Methods: 36 patients with breast cancer across the disease and treatment continuum described their experience in single qualitative interviews. Content analysis was used to define the symptom burden content domain. An expert panel scored the relevance on a 0–4 scale (4 = relevant) of the symptoms identified from the qualitative interviews. Symptoms were selected for inclusion in the MDASI-Br if they met at least 1 of the following criteria: (1) mean relevance rating of ≥3 by the expert panel, (2) described by ≥20% of patients in qualitative interviews, or (3) core MDASI items. Results: Participants had a mean age of 57.9 years, 86.1% had stage I–III, and 52.8% were on active treatment. 36 symptoms were identified, with 14 reported by ≥20% of participants. Symptoms varied among participants based on disease stage and treatment modality. Fatigue and distress were described by most women regardless of treatment, whereas arm swelling was reported only by women who had undergone surgery, and skin changes were reported primarily by women who received radiation therapy. Patients volunteered ways in which symptoms affected daily functioning. 21 symptoms were included in the MDASI-Br for psychometric testing, including 6 breast cancer-specific symptoms: breast changes, hot flashes, constipation, arm swelling, fingernail or toenail changes, and skin changes. Two additional symptoms, vaginal dryness and decrease in sexual interest or activity, were included because they are common to endocrine therapy. Conclusions: Patients with breast cancer experience numerous but distinct symptoms related to disease and treatment that may result in interference with daily activities, relationships, life plans, treatment adherence, and mood. Various treatments result in unique symptom burden. The content domain for a PRO symptom-burden measure of breast cancer encompasses the diversity, severity, and activity interference of common symptoms of breast cancer and its treatment.

Comparison of patient reported symptom burden on an enhanced recovery after surgery (ERAS) care pathway in patients with ovarian cancer undergoing primary vs. interval tumor reductive surgery

ObjectiveTo compare symptom burden and functional recovery in women undergoing primary cytoreductive surgery (PCS) or neoadjuvant chemotherapy (NACT) and interval cytoreductive surgery (ICS) within an enhanced recovery after surgery program (ERAS). MethodsSymptom burden was measured using the MD Anderson Symptom Inventory-Ovarian Cancer, a 27-item validated tool that was administered preoperatively, daily while hospitalized, and weekly for 8 weeks after hospital discharge. Mixed-effect modeling was performed. Results196 patients (71 PCS, 125 ICS) participated. Patients in the PCS group were younger, median age of 59 vs. 63 in ICS group. Median length of stay was 4 days for PCS and 3 days for ICS group. PCS pts had a significantly higher median surgical complexity score (4 vs. 2, p = 0.002), and longer median surgical time (257 min vs. 220 min, p = 0.03). While patients undergoing PCS had significantly different symptom burden profiles prior to surgery compared to those undergoing ICS, there were no significant differences in symptoms in the immediate in-hospital and extended post-hospital discharge period. Irrespective of the timing of surgery in relation to chemotherapy, patients undergoing intermediate or high complexity surgery had more nausea, fatigue, and higher total interference scores compared to patients undergoing low complexity surgery. ConclusionWithin a center with a standardized, systematic method for patient selection for PCS and a standardized ERAS care pathway, there were not significant differences in surgery-related symptoms related to recovery between patients undergoing PCS or ICS. However, patient-reported symptom burden and symptom interference did meaningfully differentiate based on surgical complexity score.

Results of a Randomized Pilot Trial of SHARE: A Self-Management Intervention for Head and Neck Cancer Patients Undergoing Radiotherapy and their Spousal Caregivers

Abstract Head and neck cancer (HNC) patients experience significant physical and psychological morbidity during radiotherapy (XRT) which contributes to treatment interruptions and poor quality of life. Although spouses/partners can help by encouraging patient self-management (e.g., self-care) during XRT, they often experience high psychological distress rates, lack basic healthcare knowledge/skills, and report increased marital conflict regarding patient self-management. This pilot study examined the feasibility and acceptability of a six-session telephone-based intervention called SHARE (Spouses coping with the Head And neck Radiation Experience), which teaches self-management, communication, and coping skills to HNC patients and their spouses. Treatment effects of SHARE relative to usual medical care (UMC) in controlling patient physical symptoms and improving patient/spouse psychological and marital functioning were also examined. METHODS: Thirty patients initiating XRT and their spouses (N = 60 participants; 40% racial/ethnic minorities) were randomized to SHARE or UMC, and pre- and post-intervention assessments were completed. RESULTS: Solid recruitment (70%) and low attrition rates (7%) demonstrated feasibility. Strong program evaluations and homework completion rates (72%) supported acceptability. Significant treatment effects (medium in magnitude) were observed for SHARE relative to UMC with regard to HNC-specific physical symptom burden (Cohen's d = −0.89) and symptom interference (d = −0.86). Medium-to-large effects favoring SHARE were also found for patient and spouse depressive symptoms (d = −0.84) and cancer-specific distress (d = −1.05). CONCLUSION: Findings support the feasibility, acceptability, and preliminary efficacy of SHARE. They also suggest that programs that empower HNC couples with the necessary skills to coordinate care and manage the challenges of XRT together hold great promise for controlling patient physical symptoms and improving both partners' psychological functioning.

Remotely programmed sacral neuromodulation for the treatment of patients with refractory overactive bladder: a prospective randomized controlled trial evaluating the safety and efficacy of a novel sacral neuromodulation device.

The efficacy and safety of a novel remotely programmed BetterStim sacral neuromodulation (SNM) system was evaluated in patients with refractory overactive bladder (OAB) in a prospective, controlled, multicenter trial. A total of 84 patients referred for SNM therapy from October 2015 to January 2018 were studied. Of the patients who qualified for implantation, 37 and 33 were randomly assigned to treatment and control groups, respectively. Patients in the treatment group underwent stimulation upon implantation, while stimulation was delayed in the control group for 3months. Follow-up visits, consisting of voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life were conducted at 1, 3, and 6-month post-implantation. Compared with the control group, subjects in the treatment group exhibited statistically significant improvement in OAB symptoms at 3months. The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3months. At 6months, there were no significant differences in key voiding diary variables between the two groups. Further, this study demonstrated sustained improvement in urinary symptom interference in OAB patients. In addition, nearly all patients expressed great satisfaction with the remote-programming methods. No serious adverse events occurred, and device-related adverse events rate was 12.86%. This clinical study demonstrates subjective and objective success of the BetterStim SNM system. Importantly, our data suggest that remote programming can be safely used as a viable option for the conventional programming with a high degree of patient satisfaction.

Patient-reported outcomes of symptom burden in patients receiving surgical or nonsurgical treatment for low-intermediate risk oropharyngeal squamous cell carcinoma: A comparative analysis of a prospective registry

PurposeTo explore treatment-related changes in symptom burden and quality of life (QOL) in oropharyngeal squamous cell cancer (OPSCC) patients treated surgically and non-surgically. Patients and MethodsEighty-six patients with human papillomavirus–associated OPSCC treated at the Head and Neck Center at The University of Texas MD Anderson Cancer Center were recruited to a prospective registry study between 2014 and 2016 and completed the core, head and neck-specific, and symptom interference sections of the MD Anderson symptom inventory (MDASI) multi-symptom questionnaire and the EQ-5D health status assessment as a measure of QOL at four time points. ResultsLongitudinal improvements from post-treatment nadir were observed across all groups. For patients treated with single modality, symptom interference, but not core and head and neck specific, MDASI scores were significantly better at 6 months in patients treated with surgery than radiation (P = 0.04). For patients treated with multiple modalities, scores for each of the three domains (i.e., core, head and neck -specific, and interference MDASI) were significantly better in the surgical group than the nonsurgical group at treatment completion (P = 0.0003, P = 0.0006 and P = 0.02) and 6 weeks (P = 0.001, P = 0.05 and P = 0.04), but not 6 months (P = 0.11, P = 0.16 and P = 0.040). No significant differences in EQ5D health status were observed between groups at any time point, reflecting similar overall QOL in all groups. ConclusionSymptom burden and QOL improves after treatment in OPSCC survivors over time regardless of whether primary surgical or nonsurgical treatment is used, although acute symptom profiles may differ.

Validation and Application of the Chinese Version of the M. D. Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI-C)

ObjectivesTo validate and use the Chinese Version of the M. D. Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI-C) to assess the symptom burden of Chinese-speaking patients with gastrointestinal cancer. MethodsIn total, 527 patients with postoperative or advanced digestive tract tumors were enrolled in the trial, who had definitive diagnoses and different treatments in our cancer center. MDASI-GI-C was administered to these patients between February and December 2017. The item-scale correlations and internal consistency were evaluated. Construct validity was established by factor analysis. Hierarchical cluster analysis was performed. ResultsCronbach's alpha of the symptom severity and interference subscales was 0.842 and 0.859, respectively. Construct validity revealed a four-factor structure. Known-group validity was established by comparing the MDASI-GI-C scores between patients having different Karnofsky Performance Status scores (≤70 or >70), which were observed to have significant differences. The overall mean subscale scores for the core and interference subscales were 1.63 ± 2.02 and 2.17 ± 2.34, respectively. Fatigue, disturbed sleep, and lack of appetite had the highest scores for most serious symptoms. No significant differences in age, working status, and educational level were found. ConclusionsMDASI-GI-C is a reliable and valid tool for assessing cancer-related symptoms in Chinese-speaking patients with digestive tract tumors, facilitates the understanding of the common symptoms of patients with digestive tract tumors, and enables timely management of these symptoms. Cognitive debriefing demonstrated that the patients found MDASI-GI-C to be an easy-to-use and understandable instrument.

Assessment of baseline symptom burden in treatment-naïve patients with lung cancer: an observational study.

Patients with newly diagnosed lung cancer who have not yet begun treatment may already be experiencing major symptoms produced by their disease. Understanding the symptomatic effects of cancer treatment requires knowledge of pretreatment symptoms (both severity and interference with daily activities). We assessed pretreatment symptom severity, interference, and quality of life (QOL) in treatment-naïve patients with lung cancer and report factors that correlated with symptom severity. This was a retrospective analysis of data collected at initial intake. Symptoms/interference were rated on the MD Anderson Symptom Inventory (MDASI) between 30days prediagnosis and 45days postdiagnosis. We examined symptom severity by disease stage and differences in severity by histology. Linear regression analyses identified significant predictors of severe pain and dyspnea. Of 460 eligible patients, 256 (62%) had adenocarcinoma, 30 (7%) had small cell carcinoma, and 100 (24%) had squamous cell carcinoma; > 30% reported moderate-to-severe (rated ≥ 5, 0-10 scale) pretreatment symptoms. The most-severe were fatigue, disturbed sleep, distress, pain, dyspnea, sadness, and drowsiness. Symptoms affected work, enjoyment of life, and general activity (interference) and physical well-being (QOL) the most. Patients with advanced disease (n = 289, 63%) had more-severe symptoms. Cancer stage was associated with pain severity; both histology and cancer stage were associated with severe dyspnea. One third of lung cancer patients were symptomatic at initial presentation. Quantification of pretreatment symptom burden can inform patient-specific palliative therapy and differentiate disease-related symptoms from treatment-related toxicities. Poorly controlled symptoms could negatively affect treatment adherence and therapeutic outcomes.