Improving compliance to endocrine therapy in breast cancer through quality of life assessments
Impact of Routine Assessment of Health-Related Quality of Life Coupled With Therapeutic Information on Compliance With Endocrine Therapy in Patients With Non-metastatic Breast Cancer
This study is testing if using tablets to check how women with early-stage hormone receptor positive breast cancer feel about their quality of life can help them stick to their hormone therapy better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Georges Francois Leclerc Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Dijon) |
| Trial ID | NCT04176809 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance compliance with endocrine therapy in women with non-metastatic hormone receptor positive breast cancer by systematically assessing health-related quality of life (HRQoL) using a tablet before consultations. Participants will be randomized into two groups, with one receiving routine HRQoL assessments coupled with therapeutic information. The study will involve 342 women who have completed their primary treatment and are about to start endocrine therapy. Data will be collected by clinical research associates to evaluate the impact of HRQoL assessments on therapy adherence.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and over with non-metastatic hormone receptor positive breast cancer who are at the end of their primary treatment and are about to start endocrine therapy.
Not a fit: Patients who have cognitive or psychiatric disorders, do not speak French, or are currently participating in another clinical trial assessing HRQoL may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve adherence to endocrine therapy, leading to better health outcomes for breast cancer patients.
How similar studies have performed: While the specific approach of combining HRQoL assessments with therapeutic information is novel, previous studies have indicated that HRQoL evaluations can improve patient outcomes and communication.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18 and over * With non-metastatic hormone receptor positive breast cancer * Women will have to be at the end of primary treatment * An indication for endocrine therapy treatment during 5 to 10 years * be affiliated to a French social security scheme or beneficiary of such a scheme * agreed to participate by signing a written consent Exclusion Criteria: * Participants who participate in another clinical trial where HRQoL is assessed * Women for whom HRQoL evaluation is not possible (cognitive disorders, psychiatric disorders, people who do not speak French, etc.). * Vulnerable participants (pregnant women, etc.)
Where this trial is running
Dijon
- Centre Georges François Leclerc — Dijon, France (Recruiting)
Study contacts
- Principal investigator: Isabelle DESMOULINS, MD — Georges François Leclerc Centre
- Study coordinator: Sandrine DABAKUYO, PhD, HDR
- Email: sdabakuyo@cgfl.fr
- Phone: 0345348067
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.