Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female ≥ 21 years old

Diagnosis of early-stage (stages zero through stage three B; 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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • STRIDE

    Behavioral

    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.

  • Usual Care

    Behavioral

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: STRIDE InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.

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

Secondary outcomes

1

Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5).

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
2

Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps).

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

Other outcomes

1

Anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).

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
2

Breast cancer symptom distress as measured by the Breast Cancer Prevention Trial Checklist (BCPT).

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
3

Quality of Life as measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B).

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.

Time frame
Up to 12 months post-baseline.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: