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

University of Colorado, Boulder88 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Breast Cancer

Interventions

EducationBEHAVIORAL

Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.

ValuesBEHAVIORAL

An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria include: 1. 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 2. Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription 3. Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult 4. Have internet access

Locations (1)

Rocky Mountain Cancer Centers

Greenwood Village, Colorado, United States

Outcomes

Primary Outcomes

Medication adherence assessed by electronic pillbox (Wisepill box)

Time frame: Change from baseline through 6 month follow-up

Secondary Outcomes

Self-reported medication adherence

Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item

Time frame: 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

Time frame: 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

Time frame: Change from baseline through 6 month follow up

Medication nonpersistence assessed by electronic pillbox (Wisepill box)

Time frame: Baseline through 6 month follow-up

Data from ClinicalTrials.gov

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