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

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: Recruiting
• Conditions: Breast Cancer; DCIS
• Intervention / Treatment: Behavioral: THRIVE Online PAT Program

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline Nealis, MPH; Phone Number: 720-897-1850; Email: archlab@colorado.edu
• Study Contact Backup: Name: Sienna Russell; Phone Number: 720-897-1850; Email: archlab@colorado.edu

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • Recruiting
      • University of Colorado Boulder
      • Principal Investigator: Joanna Arch, PhD
      • Contact: Madeline Nealis, MPH; Phone Number: 720-897-1850; Email: archlab@colorado.edu
      • Contact: Sienna Russel; Phone Number: 720-897-1850; Email: archlab@colorado.edu

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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)	Acceptability of Implementation Measure (Weimer et al., 2017)	1 week after completing the intervention
Feasibility of THRIVE intervention	Feasibility of Intervention Measure (Weimer et al., 2017)	1 week after completing the intervention
Client Satisfaction Survey	Satisfaction and feedback on THRIVE intervention	1 week after completing the intervention

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): October 12, 2024
• Study Completion (Estimated): December 12, 2024

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): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• 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