NCT Number: NCT07759947
The goal of this study is to demonstrate the efficacy of an evidence-based, small-group, telehealth intervention ('STRIDE') for improving patients' ability to cope with side effects from adjuvant endocrine therapy (AET) and adhere to AET medication regimens for patients with hormone-sensitive breast cancer.
Trial opening soon.
Get Notified21 year and older
Female
Interventional
Not applicable
Moffitt Cancer Center, Tampa, Florida, United States
Adjuvant Endocrine Therapy (AET) is critical for most patients with hormone sensitive breast cancer. AET side effects cause distress, interfere with medication adherence, and are associated with poorer quality of life (QOL) and higher anxiety. There is a critical need to increase patients' ability to cope with AET side effects and reduce adherence barriers to AET. This project proposes to conduct a multisite randomized controlled efficacy trial in 400 patients taking AET after breast cancer to test the efficacy of STRIDE, a telehealth evidence-based behavioral intervention, compared to Usual Care (UC), for improving patients' ability to cope with AET side effects. Analyses will also examine the effect of STRIDE on patients' self-reported and objective adherence. Finally, the investigative team will explore the effects of the STRIDE intervention on mood, breast cancer symptom distress, and QOL, and whether improvements in coping ability mediate the effects of the STRIDE intervention on AET adherence.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
STRIDE is a 6-session patient-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that targets coping with and managing AET side effects. The intervention incorporates psychoeducation, problem-solving, cognitive restructuring, relaxation training, symptom management skills training, coping effectiveness training, and mindfulness techniques.
Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions.
Time frame: Up to 12 months post-baseline
Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability.
Time frame: Up to 12 months post-baseline
Investigators will assess changes in adherence to treatment via the Medication Adherence Report Scale (MARS-5). The MARS-5 is a 5-tem survey used to measure AET adherence and suboptimal adherence behaviors. The scale consists of five items that are answered on a scale of 1-5, with higher scores indicating greater adherence to the medication.
Time frame: Up to 12 months post-baseline
Participants will store medication in the Medication Event Monitoring System (MEMS Caps) 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 study period between groups.
Time frame: Up to 12 months post-baseline
Investigators will assess changes in symptoms of depression and anxiety via the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, well-validated survey used widely in patients with cancer that contains two subscales assessing symptoms of depression and anxiety over the past week. Items are scored on a 0-3 scale, with higher scores indicating greater anxiety and depressive symptoms.
Time frame: Up to 12 months post-baseline
The investigators will examine changes in self-reported symptom distress using the Breast Cancer Prevention Trial Checklist (BCPT). The BCPT is a symptom checklist used to document physical and psychological symptoms associated with endocrine therapy 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: Up to 12 months post-baseline.
Investigators will assess changes in quality of life using the Functional Assessment of Cancer Therapy- Breast (FACT-B). The FACT-B is a well-validated, 37-item survey of five domains of quality of life in patients with breast cancer over the last week: physical, social, emotional, functional, well-being, and a breast cancer-specific subscale. Each item is evaluated on a 0-4 scale. Higher scores indicate greater quality of life.
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
Acronym: STRIDE
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