The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
2 other identifiers
interventional
88
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Apr 2019
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedNovember 3, 2022
November 1, 2022
1.4 years
April 29, 2019
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Medication adherence assessed by electronic pillbox (Wisepill box)
Change from baseline through 6 month follow-up
Secondary Outcomes (4)
Self-reported medication adherence
Change from baseline to 3 and 6 month follow-up
Positive and negative emotional associations with taking 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
Change from baseline through 6 month follow up
Medication nonpersistence assessed by electronic pillbox (Wisepill box)
Baseline through 6 month follow-up
Study Arms (2)
Education plus Values
EXPERIMENTALEducation
ACTIVE COMPARATORInterventions
Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.
An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Boulderlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Rocky Mountain Cancer Centers
Greenwood Village, Colorado, 80111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanna J Arch, PhD
University of Colorado, Boulder
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Psychology and Neuroscience
Study Record Dates
First Submitted
April 29, 2019
First Posted
June 10, 2019
Study Start
April 1, 2019
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
November 3, 2022
Record last verified: 2022-11