Breast Cancer
Conditions
Brief summary
This pilot trial compares two online interventions to improve adherence to anti-hormonal medication among women with the most common form of breast cancer (estrogen receptor-positive).
Interventions
BEHAVIORALEducation
Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.
BEHAVIORALValues
An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.
Sponsors
National Cancer Institute (NCI)
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
include: 1. Women in Colorado treated for Stage 0 to III estrogen receptor-positive breast cancer who have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) and within the past 2.5 years, have been prescribed anti-hormonal therapy 2. Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription 3. Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult 4. Have internet access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication adherence assessed by electronic pillbox (Wisepill box) | Change from baseline through 6 month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported medication adherence | Change from baseline to 3 and 6 month follow-up | Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item |
| Positive and negative emotional associations with taking anti-hormonal medication | Change from baseline through 6 month follow-up | Emotional Attitudes Scale, adapted to focus on anti-hormonal medication |
| Intentions to adhere to anti-hormonal medication in the next year and next several years | Change from baseline through 6 month follow up | Anti-Hormonal Medication Intentions Scale (average score on a 1 to 7 scale; higher=better outcome, e.g., stronger intentions to adhere), adapted from the Health Behavior Intentions Scale |
| Medication nonpersistence assessed by electronic pillbox (Wisepill box) | Baseline through 6 month follow-up | — |
Countries
United States
Outcome results
None listed