Skip to main content
OpenTrials
Completed

NCT Number: NCT06388304

THRIVE Study: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating DCIS Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • How upset are you by having to take anti-hormonal therapy
  • How bothered are you by the side effects?
  • 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.

Treatment and study plan

THRIVE Online PAT Program

Behavioral

Online program: behavioral intervention based on Positive Affect Training (PAT)

Primary outcomes

  1. Acceptability of THRIVE intervention (AIM)

    Time frame: 1 week post-intervention

    Acceptability of Implementation Measure (Weimer et al., 2017)

  2. Feasibility of THRIVE intervention

    Time frame: 1 week post-intervention

    Feasibility of Intervention Measure (Weimer et al., 2017)

  3. Client Satisfaction Survey

    Time frame: 1 week post-intervention

    Satisfaction and feedback on THRIVE intervention

Other outcomes

  1. 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

  2. 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

  3. 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

  4. Patient Health Questionnaire-8

    Time frame: change from baseline (pre) to 1 week post-intervention (post)

    Depression questionnaire

  5. Generalized Anxiety Disorder-7

    Time frame: change from baseline (pre) to 1 week post-intervention (post)

    anxiety symptom questionnaire

Sponsors and collaborators

Lead sponsor

Joanna Arch

Other

Registry information

Official study title

Pilot Study of Positive Affect Training for Endocrine Therapy Medication Adherence

Acronym: THRIVE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.