A pragmatic evaluation of community-based lymphoedema services for individuals at risk of, or living with, cancer-related lymphoedema

Haemoglobin (Hb) Levels and Quality of Life (Qol) in Patients (Pts) with Symptomatic Chemotherapy-Induced Anaemia (Cia): the Eaqua Study

Improvements in Hematological Parameters and Quality of Life (QOL) with Elritercept (KER-050): Results from an Ongoing Phase 2 Trial in Participants with Lower-Risk (LR) Myelodysplastic Neoplasms (MDS)

Background: The condition known as stress urinary incontinence (SUI) is characterised by the individual experiencing an urge to void themselves during physical activity, sneezing, or coughing. The purpose of this study was to evaluate QoL (quality of life) following transobturator vaginal wall sling treatment for female SUI. Methods: This prospective study was carried out on 40 women scheduled for SUI surgery. All patients were subjected to the following: Complain [Urinary incontinence(UI) severity, and other urinary symptoms to determine the type of UI either urge UI(UUI) SUI or mixed UI(MUI)], voiding dairy, physical examination, Bristol female lower urinary tract symptoms questionnaire sub scores, and ultrasonography with post voiding residual urine volume estimation. Results: The operative time recorded from the start till the end of our procedure ranged from 35 to 60 minute with a Mean ± SD of 47.4±5.63 minute. Score values of the UDI-6 and the IIQ-7 questionnaires, respectively, which reflect a significant improvement in QoL throughout the entire assessed population. Conclusions: Patients who received the transobturator vaginal wall sling reported an improvement in their QOL. A considerable number of women sustained improvements in both incontinence and QOL.

8585 Background: The association between counseling benefit and improved cancer patient survival is controversial. If such an association exists, it requires biological control of tumor growth, with the immune system as the most likely effector arm. It is widely held that for anti-tumor immunity a T helper type 1 (Th1) immune response is more advantageous, by supporting antigen-specific cytotoxicity, than a T helper type 2 (Th2). The purpose of this study was to test potential QOL, neuroendocrine and immune benefits obtained from psychosocial telephone counseling (PTC). Methods: Fifty cervical cancer patients were randomized to PTC or usual care. QOL and biological specimens were collected at baseline (3–15 months post diagnosis), and four months post-enrollment, Time 2. QOL was assessed by the FACT-Cx. Saliva was collected for the evaluation of cortisol and DHEA. Blood was collected for evaluation of selected neuroendocrine and immune parameters. We defined a Th1:Th2 ratio based upon cytokine precursor frequency determined from ELISpot assays for interferon (IFN) gamma and interleukin-(IL-) 5 performed using anti-CD3 and anti-CD28 lymphocyte stimulation. Results: We demonstrated a significant improvement in overall QOL from baseline to Time 2 for PTC participants compared to the control population (absolute difference 8.15, p=0.05). We observed longitudinal changes, up to 15 fold, in the Th1:Th2 ratio. Improvement in QOL was significantly associated with an increased Th1 immune system bias and conversely a decline in QOL with a more pronounced Th2 bias, p= 0.0097 two tailed Fisher’s exact T test and Spearman Correlation Coefficient r= 0.6368 (p= 0.0002, two tailed). Evaluation of association between QOL and the neuroendocrine parameters, salivary cortisol and DHEA, demonstrated the predicted trends, but did not reach statistical significance. Conclusions: PTC can improve QOL for cervical cancer survivors. Importantly, we have shown for the first time that changes in QOL are significantly associated with a shift of immune system Th1:Th2 stance. This provides support for a biobehavioral model, which identifies potential mechanisms by which interventions that lead to improvement in QOL could also result in improved clinical outcomes. No significant financial relationships to disclose.

Background: Financial well-being (FWB) is defined by an individual’s ability to fully meet current and ongoing financial obligations, secure their financial future, and make choices that allow them to enjoy life. High out-of-pocket costs, and lost income following a cancer diagnosis and treatment, are associated with negative financial outcomes for many cancer patients and their families. Unsurprisingly, those who start off with the fewest resources are particularly vulnerable to the financial shock of cancer. What is not known, however, is how FWB changes over time for socioeconomically vulnerable individuals or how changes in FWB following a cancer diagnosis are related to clinical outcomes. Methods: We conducted a cross-sectional survey of stage I-III breast, colorectal, and prostate cancer survivors, age 21-64 years, diagnosed between 2008 and 2016, and identified from the population-based New Mexico Tumor Registry. Participants were asked to recall their financial situation at three time points: 1) in the year prior to cancer diagnosis, 2) in the year post-diagnosis, and 3) at the time of the survey. FWB was ascertained at all three of these time points using the validated Consumer Financial Protection Bureau Financial Well Being Scale (0-100; US Population Average=54) and mental and physical QoL were determined using PROMIS measures. Propensity score weighted multivariable linear regression was used to identify factors associated with changes in FWB over time and to estimate relationships between changes in FWB and mental and physical QoL. Results: A total of 394 cancer survivors completed the survey (response rate 33%; mean age 51y, mean time since diagnosis 6y, 42% Hispanic, 52% ≤ high school degree, 22% Medicaid-insured, 31% income <$30,000, 33% rural). On average, FWB declined by 5 points (95% CI -6.17, -3.85) from the year before (mean 55, sd 14) to the year after (mean 50, sd 17) cancer diagnosis. Between the year post-diagnosis and the time of the survey (mean 53, sd 16), FWB scores increased by 3 points (95% CI 1.92, 3.98). However, cancer survivors with ≤high school degree had a significantly smaller improvement in their FWB than those with higher levels of education (estimate -2.37, 95% CI -4.44, -0.31). Importantly, each 1-point change in FWB from the year post diagnosis to the time of the survey was associated with higher mental (estimate 0.28; 95% CI 0.19-0.37) and physical (coefficient 0.19; 95% CI 0.13-0.25) QoL. Conclusion: Our data suggest that FWB declines in the year following a cancer diagnosis and rebounds thereafter. However, financial recovery is associated with important patient socioeconomic characteristics. Moreover, improvements in FWB between the year post diagnosis and the survey were associated with significant improvements in QoL. Targeted efforts to improve FWB in socioeconomically vulnerable cancer survivors, including those with lower levels of education, may be an effective strategy to reduce socioeconomic disparities in cancer outcomes that warrants further study. Citation Format: Jean A. McDougall, Jessica Anderson, Shoshana Adler Jaffe, Charles L. Wiggins, Angela L. Meisner, Dolores D. Guest, Andrew L. Sussman, V. Shane Pankratz. Financial well-being and quality of life following a cancer diagnosis: A focus on socioeconomic disparities [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr A120.

SKIN CARE MANAGEMENT OF GASTROINTESTINAL FISTULAS

Purpose: The primary aim in cancer treatment is to provide excellent tumor response while maintaining the most acceptable quality of life. The relationship of QoL to tumor response has not yet been well discussed. This study determines the association between the change in the QoL from baseline to one (1) year follow-up and tumor response among patients enrolled in the ASEAN Cost in Oncology (ACTION) study. Methods: Pooled data from the ACTION study was reviewed. Associations between demographics, cancer type, and tumor response were analyzed. Results: Of the qualified profiles (412 / 742), breast cancer (42.2%), colorectal (21.8%), and head neck (10%) are still most common. Of these cases, 126 (30.6%) were metastatic on presentation. Demographic data showed female sex having better tumor response. More importantly, tumor response was significantly associated with improvement in QoL: complete or partial response was associated with improvement in QoL (p = .000) while progressive disease related to worse situations. The general pattern seen above was reflected in female breast cancer cases, colon and rectal cancer, and other malignant neoplasms. Conclusion: Improvement in QoL was significantly associated with better tumor response. This trend was similar for breast cancer, colorectal cancer and other malignancies. The use of universal measures of health like the EQ5D 3L may be used to quantify improvements in QoL with several limitations: 1) cultural differences should be established and 2) limitations in quantifying precise changes in QoL. The utilization of more culturally adept QoL measures may address this problem. Similarly, the use of secondary data may limit the results in this study. Prospective studies specifically addressing the objectives may improve results.

Real-World Patient-Reported and Neurocognitive Outcomes in the Year After Axicabtagene Ciloleucel.

Background/ObjectivesThere is a lack of certainty in dietary prescription for individuals with inflammatory bowel disease (IBD) due to heterogeneity in studies to date. The aim of this study was to investigate the efficacy on disease activity of a modified anti-inflammatory dietary pattern purposely designed to reduce intake of food additives (IBD-MAID), compared to standard care, in adults with IBD.Subject/MethodsAdults with IBD were randomised to IBD-MAID (meals provided) [n = 29] or general healthy eating (GHE) [n = 29] for 8 weeks. Disease activity, faecal calprotectin (FC), C-reactive protein (CRP), symptoms, and quality of life (S&QOL) were assessed using validated tools.ResultsThe IBD-MAID was well tolerated and adhered to (92% adherence). At week 8, there was no statistically significant difference in change from baseline in outcome measures between groups. However, baseline to week 8 analysis indicated: (1) statistically significant improvements in S (p = 0.001) & QOL (p = 0.004), FC (p = 0.007), and Crohn’s disease activity (p = 0.03) but not ulcerative colitis, in individuals following the IBD-MAID and (2) statistically significant improvement in QOL in individuals receiving GHE (p = 0.015). Correlation analysis on change from baseline to week 8 revealed a greater decrease in food additives intake was associated with statistically significant improvements in FC, S & QOL and alignment of anti-inflammatory dietary principles with improvements in QOL.ConclusionThe IBD-MAID was well tolerated. The most novel finding pertains to the correlation between reduced food additives intake and improvements in inflammatory markers, S&QOL. Further research is needed to explore the effects of food additives exposure on IBD course.Trial registration12619001500145

Background:Mesh reinforcement is a cornerstone of modern ventral hernia repair (VHR); yet, complications with synthetic mesh and cost of biologic have created a need for alternative options. Biosynthetic mesh is a resorbable scaffold that theoretically leverages the benefits and minimizes deficiencies of existing mesh types. This study evaluates 2-year outcomes following poly-4-hydroxybutyrate (P4HB) mesh reinforcement for complex VHR.Methods:A retrospective review of all consecutive VHR with P4HB (n = 70) was conducted from 2015 to 2018 by a single surgeon. Clinical outcomes, quality of life (QoL; and cost were assessed.Results:Seventy patients were included with an average age and body mass index of 58.6 years and 33 kg/m2, respectively. High-risk comorbidities included hypertension (59%), and smoking history (50%). Cases were primarily modified Ventral Hernia Working Group class 2 (50%), or 3 (36%), with average defect size of 323 cm2 (25–972 cm2). P4HB was placed in the retromuscular (80%) or onlay (20%) plane. Mean follow-up was 24 months (12.2–41 months). Hernia recurrence rate was 5.7% (n = 4) and occurred an average of 285 days (209–368 days) post-repair. Of the 21 surgical site occurrences (SSO), 5 (7%) required surgical intervention. A significant improvement in overall QoL (P = 0.001) was noted following repair. Defect size and SSOPI were independently associated with increased direct cost.Conclusions:P4HB mesh for complex VHR is associated with favorable 2-year clinical outcomes, acceptable hernia recurrence rate, and a significant improvement in QoL. This study supports the use of biosynthetic mesh as an effective biomaterial for complex VHR.

PSU31 The Improvement of Quality of Life in Patients Treated with Bariatric Surgery

The purpose of this single-arm pilot study was to examine the effects of a community-based multimodal exercise program on: physical function (Timed-Up-and-Go [TUG], 6-min walk test [6MWT], leg and chest press strength, and functional reach [FR]); and quality of life, QoL [FACT-G]), in cancer survivors. Fifty-nine cancer survivors (91.5% female; mean age 59 ± 12 years) completed supervised exercise training for 90 min twice weekly for 12 weeks. Exercise training consisted of 30 min of each of the following: (1) aerobic conditioning; (2) resistance training; and (3) balance and flexibility training. Pre-post-outcome measures were compared for statistically significant differences (p < 0.01) and were related to the International Classification of Functioning, Disability and Health Model. Effect sizes (ES), minimal clinically important differences, and minimal detectable change at 90% confidence intervals were calculated. Participants decreased TUG time by 21.1% and walked 15.5% farther during 6-MWT (p < 0.001). Leg and chest press strength increased by 34.5% and 32.7%, respectively (p < 0.001). FR increased by 15.1% (p < 0.001). Significant improvements for physical well-being (13.9%), emotional well-being (6.7%), functional well-being (13.0%), and total well-being (9.6%) were found (p < 0.01). Improvements in physical function and QoL showed “moderate to large” ESs indicating improvements in physical function and QoL are clinically meaningful.

Gastroparesis has a significant negative impact on patients' quality of life. Only one medication is approved for gastroparesis and it is associated with a significant risk of side effects. To assess the willingness of patients to take risks associated with medications to treat gastroparesis symptoms. We developed a questionnaire to assess medication risk-taking behaviour in patients identified as having documented gastroparesis (consistent symptoms, normal upper endoscopy, delayed gastric emptying). The survey assessed demographics, symptoms, medication use, anxiety, depression and impulsivity. A standard reference gamble evaluated respondents' willingness to take medication risks. Two hundred seven questionnaires were mailed to patients, 103 questionnaires were completed. Seventy-six percent were female; the mean age was 48years; average duration of gastroparesis symptoms was 10years. Self-reported symptom severity was severe in 52% and moderate in 32%. Gastroparesis patients reported that they would accept a median 13.4% risk of sudden death to cure their symptoms using a hypothetical medication. Self-reported gastroparesis symptom severity and Gastroparesis Cardinal Symptom Index scores correlated significantly with increased willingness to take risks associated with medications to treat gastroparesis, while anxiety was negatively associated. Gastroparesis patients are willing to accept markedly high risks with a hypothetical medication to cure their symptoms. Patients with severe gastroparesis symptoms and higher Gastroparesis Cardinal Symptom Index scores were more willing to take these risks. This study, the first to quantify gastroparesis patients' willingness to accept medication associated risks, should help clinicians through the complex maze of gastroparesis therapies and their associated risks and benefits.

INTRODUCTION. The management of patients with secondary lymphedema of the lower extremities associated with radical treatment of pelvic cancer (Cancer Related Lymphedema) is extremely problematic due to persistent impairment of the draining function of regional lymph nodes due to intraoperative dissection and subsequent radiation therapy. AIM. To compare the effectiveness of complex medical rehabilitation using the kinesio taping method and innovative non-stretchable compression bandages in patients with secondary lymphedema of the lower extremities associated with radical treatment of pelvic cancer. MATERIAL AND METHODS. The study involved 60 patients with stages I-III Cancer Related Lymphedema (according to the classification of Savchenko T.V., Pokrovsky A.V., 2004) who underwent radical treatment for various forms of pelvic cancer (gynecological cancer in women and prostate cancer in men), randomized into 2 groups (30 people each). A comprehensive rehabilitation was carried out in the main group (n=30), including sequential manual lymphatic drainage, skin care, kinesio taping, therapeutic gymnastics in the gym; Adjustable Non-stretchable Compression Bandages (circaid juxtafit, Germany). Meanwhile, a Complex Decongestive Therapy was performed in the comparison group (n=30), which is considered as the gold standard of conservative treatment of lymphedema of the lower extremities, including manual lymphatic drainage, skin care, Multi-layered limb banding using Inelastic compression Bandages. In order to evaluate the anti-edematous effect the dynamics of the circumferences of the lower extremities, waist circumference and hip circumference, the Ankle Range of Motion were examined using goniometry, bio-impedancemetry. Laser Doppler Flowmetry was used to evaluate microcirculatory parameters. RESULTS AND DISCUSSION. There was a decrease in swelling and thickening of the skin in the thigh, a decrease the external genitalia edema in patients with Cancer Related Lymphedema in both groups after a course of rehabilitation. There was a regression of swelling of the feet and lower legs in patients of both groups (p&lt;0.05) after treatment, which was confirmed by a decrease in the circumferences of the lower limbs. There was an increase in the Ankle Range of Motion (dorsiflexion) from 17.50±1.26° to 19.25±1.52° (p&lt;0.05) in the main group and from 17.90±1.44° to 18.59±1.10° (p&lt;0.05) in the comparison group. According to the bio-impedancemetry data, there was a decrease in the extracellular fluid content both in the main group and the comparison group by 2.64% and 2.83%, (p&lt;0.05) respectively. There was also a comparable decrease in the total fluid content by 2.67% in the main group and 1.90% (p&lt;0.05) in the comparison group. There were a decrease in body weight by 2.49% and 1.52% (p&lt;0.001), a decrease in fat mass by 2.62% and 4.01% (p&lt;0.05) in both groups respectively after the course of treatment. According to the Laser Doppler Flowmetry data, there were an improvement in the indicators of myogenic tone of arterioles and secretory activity of the endothelium, as well as elimination of venular congestion in patients of both groups (p&lt;0.05). CONCLUSION. Regression of edema in Cancer Related Lymphedema can be achieved as a result of the use of manual lymphatic drainage which stimulates the outflow of lymph through lymphatic watersheds into adjacent lymphatic territories with intact regional lymph nodes, which was achieved in both groups. The lymphatic drainage effect of manual lymphatic drainage was supported by the daily compression profile of bandages (Multi-layered Inelastic Bandages and Adjustable Non-stretchable Compression Bandages) in patients of both groups. Our study showed that the use of kinesio tapes leveled the difference in compression of approximately 10-15 mmHg between the bandages used (50 mmHg/~60 mmHg).

Introduction: The primary aim in cancer treatment is to provide excellent tumor response while maintaining the most acceptable quality of life. The relationship of QoL to tumor response has not yet been well discussed. This study determines the association between the change in the QoL from baseline to one year follow-up and tumor response among patients enrolled in the ASEAN Cost in Oncology (ACTION) study. Methods: Pooled data from the ACTION study was reviewed. Associations between demographics, cancer type, and tumor response were analyzed. Results: Of the qualified profiles (412/ 742), breast cancer (42.2%), colorectal (21.8%), and head neck (10%) are still most common. Of these cases, 126 (30.6%) were metastatic on presentation. Demographic data showed female sex having better tumor response. More importantly, tumor response was significantly associated with improvement in QoL: complete or partial response was associated with improvement in QoL (p=.000) while progressive disease related to worse situations. The general pattern seen above was reflected in female breast cancer cases, colon and rectal cancer, and other malignant neoplasms. Conclusion: Improvement in QoL was significantly associated with better tumor response. This trend was similar for breast cancer, colorectal cancer and other malignancies. The use of universal measures of health like the EQ5D-3L may be used to quantify improvements in QoL with several limitations: 1) Cultural differences should be established and 2) Limitations in quantifying precise changes in QoL. The utilization of more culturally adept QoL measures may address this problem. Similarly, the use of secondary data may limit the results in this study. Prospective studies specifically addressing the objectives may improve results.