Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors (STRIDE)

Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial

The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Adherence, Medication
• Intervention / Treatment: Other: STRIDE; Other: Medication Monitoring Control

Detailed Description

Background: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, adherence to AET among breast cancer survivors (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and logistical factors are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and adherence challenges of BCS prescribed AET.

Objective: To address this gap, the proposed study, funded by the National Cancer Institute, employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to enhance adherence to AET, improve symptom management, and reduce distress in breast cancer survivors.

Specific Aims: The primary aims of this study are: 1) to examine the feasibility and acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a medication monitoring control for survivors of breast cancer taking AET, and 2) to explore the effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET.

Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians. The intervention is a a brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate symptoms and side effects related to hormonal therapy or breast cancer, optimize medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess the feasibility of comparing the STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the course of six months. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be hormone-receptor positive breast cancer survivors prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties, side effects, etc.). This research study involves completing 3 questionnaire batteries at the time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their hormonal therapy pills in a medication bottle provided by the study team throughout the 24 week study period. If the participants are randomized to receive the STRIDE intervention, the participant will have six weekly one-hour virtual (videoconferencing) sessions in small groups with a trained clinician followed by two 15-minute check-in phone calls later in the study.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Age 21 or older
• Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer
• Within 1 week-36 months of starting adjuvant endocrine therapy
• Ability to read and respond in English
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken within the past 2 weeks)
• Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for early-stage breast cancer
• Indicates a score ≥4 on one of the three NCCN adapted distress thermometer study screening questions

Exclusion Criteria:

• Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
• Cognitive impairment that prohibits participation in the study
• Enrollment in a different clinical trial for breast cancer
• Current participation in formal group psychotherapy or other psychosocial intervention trial
• Undergoing primary treatment for other cancer (i.e., advanced stage cancer)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: STRIDE Run-In; Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician; Two 15-minute check-in phone calls later in the study; Participants will store hormonal therapy medication in a bottle provided by the study team.; Participants will complete questionnaires at enrollment and 3-months post- enrollment	Other: STRIDE; STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.
EXPERIMENTAL: STRIDE; Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window); Two 15-minute check-in phone calls later in the study; Participants will store hormonal therapy medication in a bottle provided by the study team.; Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment	Other: STRIDE; STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.
ACTIVE_COMPARATOR: Medication Monitoring Control; Medication monitoring plus standard care; Participants will store hormonal therapy medication in a bottle provided by the study team.; Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment	Other: Medication Monitoring Control; Care provided as standard by the hospital and medication monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and Acceptability	The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate > 50%), retention (follow-up assessment completion rate > 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]). The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if >75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period	Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.	Mean medication adherence rates over 24 weeks
Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline	Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as "I stop taking my adjuvant endocrine therapy medicine for a while." Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the medication.	Baseline, and post-intervention at 12-weeks post-baseline
Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.	Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale. Each item is scored on a scale of 1 ("Never" or "Very inconvenient") to 5 ("Always" or Very Convenient"). A greater score on this measure indicates greater patient cancer therapy satisfaction. Scores can range from a minimum of 0 to a maximum of 100.	Baseline, and post-intervention at 12-weeks post-baseline
Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline	Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.	Baseline and post-intervention at 12 weeks post-baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jamie M. Jacobs, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Jacobs JM, Rapoport CS, Horenstein A, Clay M, Walsh EA, Peppercorn J, Temel JS, Greer JA. 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 Jan 4;11(1):e041626. doi: 10.1136/bmjopen-2020-041626.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2019
• Primary Completion (ACTUAL): August 17, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (ACTUAL): February 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Distress; Endocrine Therapy; Symptoms; Survivors; Hormonal Therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 18-603; K07CA211107 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No