scholarly journals Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041626
Author(s):  
Jamie M Jacobs ◽  
Chelsea S Rapoport ◽  
Arielle Horenstein ◽  
Madison Clay ◽  
Emily A Walsh ◽  
...  

IntroductionPatient adherence to adjuvant endocrine therapy (AET) after a diagnosis of hormone-sensitive breast cancer is poor. Previous interventions have failed to produce changes in adherence, address patient preferences or include theoretically informed and evidence-based components. Therefore, we iteratively developed a patient-centred, evidence-based, small-group, videoconference intervention to improve adherence and symptom management as well as reduce distress for patients taking AET after breast cancer (Symptom-Targeted Randomised Intervention for Distress and Adherence to Adjuvant Endocrine Therapy, STRIDE).Methods and analysisThe current study is a non-blinded, randomised, controlled, feasibility trial of STRIDE compared with a medication monitoring control group. The primary objective is to examine the feasibility and acceptability of STRIDE, while secondary objectives are to assess changes in objective and subjective adherence, symptom distress and satisfaction with AET. Patients will be recruited from the Massachusetts General Hospital Cancer Center in Boston, Massachusetts. The total number of patients accrued will be 75, with ≥60 patients completing the study. All patients will store their AET in an electronic pill bottle for objective adherence monitoring. Patients randomly assigned to the STRIDE intervention will receive 6 weekly 1-hour sessions, in small groups of two, delivered via videoconferencing by a trained mental health professional. Patients assigned to the control group will store their medication in the electronic pill bottle and receive follow-up oncology care as usual. All participants will complete self-report psychosocial measures at baseline, 12 weeks and 24 weeks postbaseline.Ethics and disseminationThe study is funded by the National Cancer Institute of the National Institutes of Health and is approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #18–603, V.1.2, first approval date 1 February 2019). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets.Trial registration numberNCT03837496; Pre-results.

Author(s):  
Maria Alice Franzoi ◽  
Elisa Agostinetto ◽  
Marta Perachino ◽  
Lucia Del Mastro ◽  
Evandro de Azambuja ◽  
...  

Author(s):  
Carmen W.H. Chan ◽  
Daria Tai ◽  
Stephanie Kwong ◽  
Ka Ming Chow ◽  
Dorothy N.S. Chan ◽  
...  

Breast cancer survivors need to undergo adjuvant endocrine therapy after completion of curative treatments to prevent disease recurrence. These individuals often experience symptoms which are detrimental to their quality of life (QOL). Implementation of interventions for effective symptom management among these survivors is warranted. This review provides an overview of studies on the effectiveness of the previously developed interventions for breast cancer survivors undergoing adjuvant endocrine therapy on symptom alleviation and enhancement of QOL or health-related QOL (HRQOL). Five electronic databases were employed in the literature search. Study selection, data extraction and critical appraisal of the included studies were conducted by three authors independently. Twenty-four studies were included. Both pharmacological and non-pharmacological interventions are effective in addressing the symptoms associated with adjuvant endocrine therapy among the breast cancer survivors, and in improving their QOL, although discrepancies were noted between the studies in terms of the significance of these effects. Pharmacological and non-pharmacological interventions can be effective for symptom management among breast cancer survivors. Their implementation is recommended for effective survivorship care for these individuals. Further research on intervention development for breast cancer survivors is recommended to provide further evidence for the utility of the explored interventions in survivorship care for these patients.


2017 ◽  
Vol 35 (1) ◽  
pp. 86-95 ◽  
Author(s):  
Albert J. Farias ◽  
Xianglin L. Du

Purpose Previous studies suggest that adherence to adjuvant endocrine therapy (AET) for patients with breast cancer is suboptimal, especially among minorities, and is associated with out-of-pocket medication costs. This study aimed to determine whether there are racial/ethnic differences in 1-year adherence to AET and whether out-of-pocket costs explain the racial/ethnic disparities in adherence. Methods This retrospective cohort study used the SEER-Medicare linked database to identify patients ≥ 65 years of age with hormone receptor–positive breast cancer who were enrolled in Medicare Part D from 2007 to 2009. The cohort included non-Hispanic whites, blacks, Hispanics, and Asians. Out-of-pocket costs for AET medications were standardized for a 30-day supply. Adherence to tamoxifen, aromatase inhibitors (AIs), and overall AET (tamoxifen or AIs) was assessed using the medication possession ratio (≥ 80%) during the 12-month period. Results Of 8,688 patients, 3,197 (36.8%) were nonadherent to AET. Out-of-pocket costs for AET medication were associated with lower adjusted odds of adherence for all four cost categories compared with the lowest category of ≤ $2.65 ( P < .01). In the univariable analysis, Hispanics had higher odds of adherence to any AET at initiation (OR, 1.30; 95% CI, 1.07 to 1.57), and blacks had higher odds of adherence to AIs at initiation (OR, 1.27; 95% CI, 1.04 to 1.54) compared with non-Hispanic whites. After adjusting for copayments, poverty status, and comorbidities, the association was no longer significant for Hispanics (OR, 0.95; 95% CI, 0.78 to 1.17) or blacks (OR, 0.96; 95% CI, 0.77 to 1.19). Blacks had significantly lower adjusted odds of adherence than non-Hispanic whites when they initiated AET therapy with tamoxifen (OR, 0.54; 95% CI, 0.31 to 0.93) after adjusting for socioeconomic, clinic, and prognostic factors. Conclusion Racial/ethnic disparities in AET adherence were largely explained by women's differences in socioeconomic status and out-of-pocket medication costs.


2021 ◽  
pp. 135910532199077
Author(s):  
Eng Hooi Tan ◽  
Andrea Li Ann Wong ◽  
Chuan Chien Tan ◽  
Patrick Wong ◽  
Sing Huang Tan ◽  
...  

The Beliefs about Medicines Questionnaire (BMQ) and Adherence Starts with Knowledge (ASK-12) questionnaire were originally developed and validated in Western populations to assess beliefs and barriers to medication adherence. The study aim is to validate the BMQ and ASK-12 questionnaire for use in a Singapore population with early stage breast cancer. English-speaking women on adjuvant endocrine therapy ( n = 157) were recruited. The BMQ-Specific showed good internal consistency with structural validity. The internal consistency of BMQ-General and ASK-12 Behaviour scale improved with the new factor structure obtained from exploratory factor analysis. Further studies are needed to confirm these factor structures.


Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 2115
Author(s):  
Panos Papandreou ◽  
Aristea Gioxari ◽  
Frantzeska Nimee ◽  
Maria Skouroliakou

Clinical decision support systems (CDSS) are data aggregation tools based on computer technology that assist clinicians to promote healthy weight management and prevention of cardiovascular diseases. We carried out a randomised controlled 3-month trial to implement lifestyle modifications in breast cancer (BC) patients by means of CDSS during the COVID-19 pandemic. In total, 55 BC women at stages I-IIIA were enrolled. They were randomly assigned either to Control group, receiving general lifestyle advice (n = 28) or the CDSS group (n = 27), to whom the CDSS provided personalised dietary plans based on the Mediterranean diet (MD) together with physical activity guidelines. Food data, anthropometry, blood markers and quality of life were evaluated. At 3 months, higher adherence to MD was recorded in the CDSS group, accompanied by lower body weight (kg) and body fat mass percentage compared to control (p < 0.001). In the CDSS arm, global health/quality of life was significantly improved at the trial endpoint (p < 0.05). Fasting blood glucose and lipid levels (i.e., cholesterol, LDL, triacylglycerols) of the CDSS arm remained unchanged (p > 0.05) but were elevated in the control arm at 3 months (p < 0.05). In conclusion, CDSS could be a promising tool to assist BC patients with lifestyle modifications during the COVID-19 pandemic.


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