Breast Cancer Clinical Trial
— STRIDEOfficial title:
Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial
Verified date | November 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 1, 2021 |
Est. primary completion date | August 17, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Months and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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