Online program to improve emotional attitudes towards breast cancer medication
Pilot Study of Positive Affect Training for Endocrine Therapy Medication Adherence
NA · University of Colorado, Boulder · NCT06388304
This study is testing an online program to help breast cancer survivors feel more positive about their medication and reduce negative feelings about it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | University of Colorado, Boulder (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT06388304 on ClinicalTrials.gov |
What this trial studies
This study aims to pilot an online behavioral intervention called Positive Affect Training (PAT) designed to enhance positive emotional attitudes and reduce negative feelings towards endocrine therapy among post-treatment breast cancer survivors. Participants will engage with the THRIVE Online PAT Program, which focuses on increasing positive affect and decreasing negative affect related to their medication regimen. The study targets hormone receptor-positive breast cancer patients who have completed primary treatment and are currently prescribed endocrine therapy or have been within the last two years.
Who should consider this trial
Good fit: Ideal candidates are post-treatment breast cancer survivors with hormone receptor-positive disease who are currently prescribed or have been prescribed endocrine therapy within the last two years.
Not a fit: Patients with metastatic disease or those unable to interact with the intervention due to severe visual impairment or language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve medication adherence and emotional well-being for breast cancer survivors.
How similar studies have performed: While this approach is innovative, similar studies focusing on emotional support and medication adherence have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boulder, Colorado
- University of Colorado Boulder — Boulder, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Joanna Arch, PhD — University of Colorado, Boulder
- Study coordinator: Madeline Nealis, MPH
- Email: archlab@colorado.edu
- Phone: 720-897-1850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, DCIS