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

November 1, 2022 updated by: Joanna Arch, University of Colorado, Boulder

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Rocky Mountain Cancer Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported medication adherence
Time Frame: Change from baseline to 3 and 6 month follow-up
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
Time Frame: Change from baseline through 6 month follow-up
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
Time Frame: Change from baseline through 6 month follow up
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)
Time Frame: Baseline through 6 month follow-up
Baseline through 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Boulder

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Joanna J Arch, PhD, University of Colorado, Boulder

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0234
  • R21CA218723 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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