THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence

NCT06388304 | Completed

• 1 other identifier: 23-0556
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; DCIS

Outcome Measures

Primary Outcomes (3)

• Acceptability of THRIVE intervention (AIM)

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

  1 week post-intervention

• Feasibility of THRIVE intervention

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

  1 week post-intervention

• Client Satisfaction Survey

  Satisfaction and feedback on THRIVE intervention

  1 week post-intervention

Other Outcomes (5)

• Adjuvant endocrine therapy medication adherence (patient-reported)

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

• Positive and Negative Affect Scales (PANAS)

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

• Emotional attitudes toward adjuvant endocrine therapy

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

Study Arms (1)

Online Program

EXPERIMENTAL

Online program

Behavioral: THRIVE Online PAT Program

Interventions

THRIVE Online PAT Program BEHAVIORAL

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

Online Program

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joanna Arch: lead

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Related Publications (4)

• Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396.

  PMID: 30998048 BACKGROUND

• Craske MG, Meuret AE, Ritz T, Treanor M, Dour HJ. Treatment for Anhedonia: A Neuroscience Driven Approach. Depress Anxiety. 2016 Oct;33(10):927-938. doi: 10.1002/da.22490.

  PMID: 27699943 BACKGROUND

• Craske MG, Meuret AE, Echiverri-Cohen A, Rosenfield D, Ritz T. Positive affect treatment targets reward sensitivity: A randomized controlled trial. J Consult Clin Psychol. 2023 Jun;91(6):350-366. doi: 10.1037/ccp0000805. Epub 2023 Mar 9.

  PMID: 36892884 BACKGROUND

• Arch JJ, Crespi CM, Levin ME, Genung SR, Nealis M, Mitchell JL, Bright EE, Albright K, Magidson JF, Stanton AL. Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors. Ann Behav Med. 2022 Aug 2;56(8):856-871. doi: 10.1093/abm/kaab118.

  PMID: 35323853 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

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

Study Officials

• Joanna Arch, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 29, 2024
• Study Start: March 12, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)