Telephone support to help breast cancer patients stick to their hormone therapy
Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility
This study tests whether daily text reminders and weekly check-ins by phone can help women with early-stage breast cancer stick to their hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 4 sites (Goldsboro, North Carolina and 3 other locations) |
| Trial ID | NCT02400060 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates a telephone-based intervention aimed at improving adherence to adjuvant hormonal therapy in women diagnosed with early-stage breast cancer. The approach involves daily text message reminders and weekly interactive surveys delivered through a smartphone app over a three-month period. The study also explores the impact of demographic and psychosocial factors on adherence outcomes, while assessing the feasibility of the intervention through recruitment and protocol completion rates. Feedback from patients and physicians regarding the intervention components will also be collected.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women diagnosed with stage I-III breast cancer who are eligible for adjuvant hormonal therapy and own a smartphone.
Not a fit: Patients who are not post-menopausal or those who do not own a smartphone may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence among breast cancer patients, potentially leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promise with similar telephone-based interventions to enhance medication adherence, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Eligible women are those who:
* Are post-menopausal, verified by:
* Post bilateral surgical oophorectomy; or
* No spontaneous menses \>= 1 year; or
* No menses for \< 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
* Are diagnosed with primary breast cancer (BC) (stages I-III)
* Eligible to receive AHT (tamoxifen or an aromatase inhibitors \[AI\]) for the first time
* Completed all primary treatment
* Own a smartphone (in order to receive text messages and utilize the phone app)
* Agree to receive text messages on their smartphone over a 3-month period
* Provide consent and permission to review their medical records
* Plan to stay in the study area for 3 months
Where this trial is running
Goldsboro, North Carolina and 3 other locations
- Southeastern Medical Oncology Center-Goldsboro — Goldsboro, North Carolina, United States (Active_not_recruiting)
- Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States (Active_not_recruiting)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
- Fletcher Allen Health Care-Medical Center — Burlington, Vermont, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Michelle Naughton, PhD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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.