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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980093
• Other study ID #: 18-0234
• Secondary ID: R21CA218723
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2022
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Education
Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.
• Values
An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.

Locations

Country	Name	City	State
United States	Rocky Mountain Cancer Centers	Greenwood Village	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence assessed by electronic pillbox (Wisepill box)		Change from baseline through 6 month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Medication nonpersistence assessed by electronic pillbox (Wisepill box)		Baseline through 6 month follow-up