Back to resultsThe REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Values
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Rocky Mountain Cancer Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Education plus Values
Education
Arm Description
Outcomes
Primary Outcome Measures
Medication adherence assessed by electronic pillbox (Wisepill box)
Secondary Outcome Measures
Self-reported medication adherence
Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item
Positive and negative emotional associations with taking anti-hormonal medication
Emotional Attitudes Scale, adapted to focus on anti-hormonal medication
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
Medication nonpersistence assessed by electronic pillbox (Wisepill box)
Full Information
NCT ID
NCT03980093
First Posted
April 29, 2019
Last Updated
November 1, 2022
Sponsor
University of Colorado, Boulder
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03980093
Brief Title
The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
Official Title
A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education plus Values
Arm Type
Experimental
Arm Title
Education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.
Intervention Type
Behavioral
Intervention Name(s)
Values
Intervention Description
An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.
Primary Outcome Measure Information:
Title
Medication adherence assessed by electronic pillbox (Wisepill box)
Time Frame
Change from baseline through 6 month follow-up
Secondary Outcome Measure Information:
Title
Self-reported medication adherence
Description
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
Title
Positive and negative emotional associations with taking anti-hormonal medication
Description
Emotional Attitudes Scale, adapted to focus on anti-hormonal medication
Time Frame
Change from baseline through 6 month follow-up
Title
Intentions to adhere to anti-hormonal medication in the next year and next several years
Description
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
Title
Medication nonpersistence assessed by electronic pillbox (Wisepill box)
Time Frame
Baseline through 6 month follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna J Arch, PhD
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Cancer Centers
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
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