Adherence, Medication, Breast Cancer
Conditions
Keywords
Breast Cancer, Endocrine Therapy, Hormonal Therapy, Symptoms, Distress, Survivors
Brief summary
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.
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.
Interventions
OTHERSTRIDE
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.
OTHERMedication Monitoring Control
Care provided as standard by the hospital and medication monitoring
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to the participant's study condition
Eligibility
Sex/Gender
FEMALE
Age
21 Months to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period | Mean medication adherence rates over 24 weeks | 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. |
| 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 | Baseline, and post-intervention at 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. |
| Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline. | Baseline, and post-intervention at 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. |
| Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline | Baseline and post-intervention at 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | STRIDE | Medication Monitoring Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 37 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 13 Participants | 28 Participants |
| Age, Continuous | 57.2 years STANDARD_DEVIATION 10.6 | 54.9 years STANDARD_DEVIATION 11.2 | 56.1 years STANDARD_DEVIATION 10.9 |
| Breast Cancer Stage Stage 0 | 5 Participants | 3 Participants | 8 Participants |
| Breast Cancer Stage Stage I | 36 Participants | 41 Participants | 77 Participants |
| Breast Cancer Stage Stage II | 6 Participants | 10 Participants | 16 Participants |
| Breast Cancer Stage Stage III | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 47 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Ovarian Suppression Not Receiving Ovarian Suppression | 42 Participants | 30 Participants | 72 Participants |
| Ovarian Suppression Receiving Ovarian Suppression | 8 Participants | 20 Participants | 28 Participants |
| Race/Ethnicity, Customized African American or Black | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 47 Participants | 44 Participants | 91 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of Adjuvant Endocrine Therapy Aromatase Inhibitor | 28 Participants | 32 Participants | 60 Participants |
| Type of Adjuvant Endocrine Therapy Tamoxifen | 22 Participants | 18 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STRIDE | Feasibility and Acceptability | Feasibility - Retention at Week 12 | 46 Participants |
| STRIDE | Feasibility and Acceptability | Feasibility - Session Attendance | 45 Participants |
| STRIDE | Feasibility and Acceptability | Acceptability | 41 Participants |
| Medication Monitoring Control | Feasibility and Acceptability | Feasibility - Retention at Week 12 | 47 Participants |
| Medication Monitoring Control | Feasibility and Acceptability | Feasibility - Session Attendance | 47 Participants |
| Medication Monitoring Control | Feasibility and Acceptability | Acceptability | NA Participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| STRIDE | 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 |
| Medication Monitoring Control | Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline. | 63.94 units on a scale |
Comparison: Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.p-value: 0.18695% CI: [-1.27, 6.44]ANCOVA
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| STRIDE | 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 |
| Medication Monitoring Control | 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 | 23.86 units on a scale |
Comparison: Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.p-value: 0.6395% CI: [-0.4, 0.66]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| STRIDE | 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 |
| Medication Monitoring Control | Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline | 20.67 units on a scale |
Comparison: Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.p-value: 0.56295% CI: [-3.49, 1.91]ANCOVA
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.
Time frame: Mean medication adherence rates over 24 weeks
Population: Analysis Population includes the participants in both arms using the MEMs caps throughout the study period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| STRIDE | Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period | 84.75 percentage of medication taken |
| Medication Monitoring Control | Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period | 82.00 percentage of medication taken |
Comparison: Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.p-value: 0.50495% CI: [-2.59, 1.27]ANCOVA
Comparison: Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.p-value: 0.22595% CI: [-0.44, -0.1]ANCOVA