Hormone Receptor Positive Breast Cancer
Conditions
Keywords
Hormone Receptor Positive Breast Cancer, Adjuvant Endocrine Therapy Adherence, Coping, Supportive Care, Behavioral Intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSTRIDE
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.
BEHAVIORALUsual Care
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.
Sponsors
Massachusetts General Hospital
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female ≥ 21 years old * Diagnosis of early-stage (0-IIIb), hormone receptor positive (ER+/PR+) breast cancer * Completed primary treatment (surgery, chemotherapy, and/or radiation) * Within 3 to 12 months of starting oral adjuvant endocrine therapy (AET) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Ability to read and respond in English or Spanish * Distress about AET ≥ 4 on a 0-10 scale
Exclusion criteria
* Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the treating oncologist * Enrolled in a clinical trial for AET
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5). | 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. |
| Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps). | 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. |
Countries
United States
Contacts
CONTACTJamie M Jacobs, PhD
PRINCIPAL_INVESTIGATORJamie M Jacobs, PhD
Massachusetts General Hospital
Outcome results
None listed