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Trial Title:
THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence
NCT ID:
NCT06388304
Condition:
Breast Cancer
DCIS
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
THRIVE Online PAT Program
Description:
Online program: behavioral intervention based on Positive Affect Training (PAT)
Arm group label:
Online Program
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.
Criteria for 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.
Gender:
Female
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Boulder
Address:
City:
Boulder
Zip:
80309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sienna Russel
Phone:
720-897-1850
Email:
archlab@colorado.edu
Contact backup:
Last name:
Madeline Nealis, MPH
Phone:
720-897-1850
Email:
archlab@colorado.edu
Investigator:
Last name:
Joanna Arch, PhD
Email:
Principal Investigator
Start date:
March 12, 2024
Completion date:
December 12, 2024
Lead sponsor:
Agency:
Joanna Arch
Agency class:
Other
Source:
University of Colorado, Boulder
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06388304
