THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence

Not Applicable

Recruiting

• Conditions: DCIS; Breast Cancer
• Interventions: Behavioral: THRIVE Online PAT Program

• Registration Number: NCT06388304
• Lead Sponsor: Joanna Arch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-12
• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29
• Primary Completion: 2024-10-12
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Online Program	THRIVE Online PAT Program	Online program

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Boulder; 🇺🇸 Boulder, Colorado, United States