Trial Outcomes & Findings for Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors (NCT NCT03837496)

Last Updated: 2022-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-11-18

Participant Flow

Study recruitment paused due to the COVID-19 pandemic from mid-March 2020 through May of 2020. Run-in participants were not enrolled as part of the randomized controlled trial. The purpose of the run-in arm was to trial the intervention content with participants and the purpose of any data collection in this arm was to refine the intervention content to enhance acceptability and feasibility for the RCT. Since run-in participants were not enrolled in the RCT we are not reporting these results.

Participant milestones

Participant milestones
Measure	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 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.	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 Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring
Overall Study STARTED	50	50
Overall Study COMPLETED	45	47
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STRIDE n=50 Participants * 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 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.	Medication Monitoring Control n=50 Participants * 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 Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Age, Continuous	57.2 years STANDARD_DEVIATION 10.6 • n=5 Participants	54.9 years STANDARD_DEVIATION 11.2 • n=7 Participants	56.1 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized African American or Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	47 Participants n=5 Participants	44 Participants n=7 Participants	91 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Type of Adjuvant Endocrine Therapy Aromatase Inhibitor	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Type of Adjuvant Endocrine Therapy Tamoxifen	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Breast Cancer Stage Stage 0	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Breast Cancer Stage Stage I	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Breast Cancer Stage Stage II	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Breast Cancer Stage Stage III	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ovarian Suppression Receiving Ovarian Suppression	8 Participants n=5 Participants	20 Participants n=7 Participants	28 Participants n=5 Participants
Ovarian Suppression Not Receiving Ovarian Suppression	42 Participants n=5 Participants	30 Participants n=7 Participants	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The analysis populations are as follows. Feasibility: Enrollment - 141 eligible participants were approached and 100 participants enrolled (70.9%). For the remainder of the feasibility analyses, the analysis population will utilize a denominator of 100 participants enrolled to the STRIDE study. For the acceptability analysis, the analysis population will utilize a denominator of the 43 participants who completed at least four out of the six STRIDE sessions.

Outcome measures

Outcome measures
Measure	STRIDE n=50 Participants * 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 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.	Medication Monitoring Control n=50 Participants * 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 Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring
Feasibility and Acceptability Feasibility - Retention at Week 12	46 Participants	47 Participants
Feasibility and Acceptability Feasibility - Session Attendance	45 Participants	47 Participants
Feasibility and Acceptability Acceptability	41 Participants	NA Participants The Medication Monitoring Control Group did not attend intervention sessions and so did not rate acceptability.

SECONDARY outcome

Timeframe: Mean medication adherence rates over 24 weeks

Population: Analysis Population includes the participants in both arms using the MEMs caps throughout the 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.

Outcome measures

Outcome measures
Measure	STRIDE n=45 Participants * 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 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.	Medication Monitoring Control n=47 Participants * 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 Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring
Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period	84.75 percentage of medication taken Interval 78.8 to 90.7	82.00 percentage of medication taken Interval 75.98 to 88.03

SECONDARY outcome

Timeframe: Baseline, and post-intervention at 12-weeks post-baseline

Population: Analysis Population includes the participants in both arms that completed the MARS-5 measure at 12 weeks

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.

Outcome measures

Outcome measures
Measure	STRIDE n=45 Participants * 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 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.	Medication Monitoring Control n=47 Participants * 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 Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring
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	23.99 units on a scale Interval 23.61 to 24.36	23.86 units on a scale Interval 23.49 to 24.23

SECONDARY outcome

Timeframe: Baseline, and post-intervention at 12-weeks post-baseline

Population: The analysis population includes the 92 participants in the STRIDE study who completed the CTSQ at 12 weeks.

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.

Outcome measures

Outcome measures
Measure	STRIDE n=45 Participants * 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 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.	Medication Monitoring Control n=47 Participants * 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 Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring
Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.	66.53 units on a scale Interval 63.82 to 69.23	63.94 units on a scale Interval 61.3 to 66.58

SECONDARY outcome

Timeframe: Baseline and post-intervention at 12 weeks post-baseline

Population: The analysis population includes the 92 participants in the STRIDE study who completed the BCPT at 12 weeks.

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.

Outcome measures

Outcome measures
Measure	STRIDE n=45 Participants * 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 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.	Medication Monitoring Control n=47 Participants * 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 Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring
Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline	19.89 units on a scale Interval 17.98 to 21.79	20.67 units on a scale Interval 18.82 to 22.53

Adverse Events

STRIDE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medication Monitoring Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jamie Jacobs, PhD

Massachusetts General Hospital

Phone: 617-643-1777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place