The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors

Study Overview
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Brief Summary
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This pilot trial compares two online interventions to improve adherence to anti-hormonal medication among women with the most common form of breast cancer (estrogen receptor-positive).

Official Title
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A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Values


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include: Women in Colorado treated for Stage 0 to III estrogen receptor-positive breast cancer who have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) and within the past 2.5 years, have been prescribed anti-hormonal therapy Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult Have internet access

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education plus Values<br> | Behavioral: Education<br>* Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.<br>Behavioral: Values<br>* An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.<br>|
| Active Comparator: Education<br> | Behavioral: Education<br>* Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence assessed by electronic pillbox (Wisepill box) |  | Change from baseline through 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported medication adherence | Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item | Change from baseline to 3 and 6 month follow-up | 
| Positive and negative emotional associations with taking anti-hormonal medication | Emotional Attitudes Scale, adapted to focus on anti-hormonal medication | Change from baseline through 6 month follow-up | 
| Intentions to adhere to anti-hormonal medication in the next year and next several years | Anti-Hormonal Medication Intentions Scale (average score on a 1 to 7 scale; higher=better outcome, e.g., stronger intentions to adhere), adapted from the Health Behavior Intentions Scale | Change from baseline through 6 month follow up | 
| Medication nonpersistence assessed by electronic pillbox (Wisepill box) |  | Baseline through 6 month follow-up |