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THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence

J

Joanna Arch

Status

Completed

Conditions

Breast Cancer
DCIS

Treatments

Behavioral: THRIVE Online PAT Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06388304
23-0556

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

39 participants in 1 patient group

Online Program
Experimental group
Description:
Online program
Treatment:
Behavioral: THRIVE Online PAT Program

Trial contacts and locations

1

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Central trial contact

Sienna Russell; Madeline Nealis, MPH

Data sourced from clinicaltrials.gov

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