THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence (THRIVE)

January 15, 2026 updated by: Joanna Arch

Pilot Study of Positive Affect Training for Endocrine Therapy Medication Adherence

The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

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
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • hormone receptor-positive breast cancer stages 0-3
  • have finished primary treatment (chemotherapy/radiation/surgery)
  • are prescribed endocrine therapy (ET) currently or within the last two years

  • score above specified cut off (range, 0-10) on any of three questions:

    1. How upset are you by having to take anti-hormonal therapy
    2. How bothered are you by the side effects?
    3. How difficult is it for you to take your anti-hormonal medication every day?
  • have internet access to complete online assessments and intervention components or agree to use and return a study wifi-activated iPad.

Exclusion Criteria:

  • metastatic disease
  • Individuals who are unable to interact with the intervention as needed. This includes those who are extremely visually impaired to the degree that they cannot see the screen and interact as required and individuals who cannot read and/or write in English. This is due to the nature of the intervention itself. If a participant is unable to interact with THRIVE as required, they are unlikely to benefit from the intervention or offer insightful feedback that can be used in refining the program.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Program
Online program
Behavioral: THRIVE Online PAT Program
Online program: behavioral intervention based on Positive Affect Training (PAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of THRIVE intervention (AIM)
Time Frame: 1 week post-intervention
Acceptability of Implementation Measure (Weimer et al., 2017)
1 week post-intervention
Feasibility of THRIVE intervention
Time Frame: 1 week post-intervention
Feasibility of Intervention Measure (Weimer et al., 2017)
1 week post-intervention
Client Satisfaction Survey
Time Frame: 1 week post-intervention
Satisfaction and feedback on THRIVE intervention
1 week post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjuvant endocrine therapy medication adherence (patient-reported)
Time Frame: change from baseline (pre) to 1 week post-intervention (post)
Wilson et al, 2016, validated 3-item measure of adherence to oral medication
change from baseline (pre) to 1 week post-intervention (post)
Positive and Negative Affect Scales (PANAS)
Time Frame: change from baseline (pre) to 1 week post-intervention (post)
Scales that assess positive and negative affect, respectively
change from baseline (pre) to 1 week post-intervention (post)
Emotional attitudes toward adjuvant endocrine therapy
Time Frame: change from baseline (pre) to 1 week post-intervention (post)
assessed each positive and negative affective attitudes toward (e.g., emotions associated with) adjuvant endocrine therapy on separate scales, from Rosenberg et al, 2015
change from baseline (pre) to 1 week post-intervention (post)
Patient Health Questionnaire-8
Time Frame: change from baseline (pre) to 1 week post-intervention (post)
Depression questionnaire
change from baseline (pre) to 1 week post-intervention (post)
Generalized Anxiety Disorder-7
Time Frame: change from baseline (pre) to 1 week post-intervention (post)
anxiety symptom questionnaire
change from baseline (pre) to 1 week post-intervention (post)

Collaborators and Investigators

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

Sponsor

Joanna Arch

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 12, 2024

Primary Completion (Actual)

April 18, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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