Clinical trial NCT06388304: THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence
Official title: Pilot Study of Positive Affect Training for Endocrine Therapy Medication Adherence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
DCIS
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of THRIVE intervention (AIM)
timeFrame: 1 week after completing the intervention
measure: Feasibility of THRIVE intervention
timeFrame: 1 week after completing the intervention
measure: Client Satisfaction Survey
timeFrame: 1 week after completing the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Joanna Arch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.