THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence

Breast Cancer Clinical Trial

— THRIVE  

Official title:

Pilot Study of Positive Affect Training for Endocrine Therapy Medication Adherence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388304
• Other study ID #: 23-0556
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: December 12, 2024

Study information

• Verified date: April 2024
• Source: University of Colorado, Boulder
• Contact: Madeline Nealis, MPH
• Phone: 720-897-1850
• Email: archlab[@]colorado.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 12, 2024
• Est. primary completion date: October 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• DCIS

Intervention

Behavioral:
• THRIVE Online PAT Program
Online program: behavioral intervention based on Positive Affect Training (PAT)

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Joanna Arch

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of THRIVE intervention (AIM)	Acceptability of Implementation Measure (Weimer et al., 2017)	1 week after completing the intervention
Primary	Feasibility of THRIVE intervention	Feasibility of Intervention Measure (Weimer et al., 2017)	1 week after completing the intervention
Primary	Client Satisfaction Survey	Satisfaction and feedback on THRIVE intervention	1 week after completing the intervention