Digital support program for women with breast cancer
Digital Patient Support Program for Self-Efficacy and Medication Adherence Amongst Women on Adjuvant Endocrine Treatment for Breast Cancer: A Randomized Controlled Trial
This study tests whether a digital support program can help women with breast cancer stick to their medication and feel more confident during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sidekick Health Industry-sponsored |
| Locations | 1 site (Reykjavik) |
| Trial ID | NCT06989450 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Sidekick Health's digital patient support program in enhancing self-efficacy and medication adherence among women undergoing adjuvant endocrine treatment for breast cancer. Participants will be randomly assigned to receive either the digital program alongside standard care or standard care alone. The program includes tools and resources aimed at improving medication adherence and promoting lifestyle changes. A total of 140 participants will be involved in this controlled trial.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 or older diagnosed with stage I, II, or III breast cancer who have been prescribed adjuvant endocrine therapy.
Not a fit: Patients with metastatic breast cancer or those currently participating in another clinical study may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve medication adherence and self-management among breast cancer patients, leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promising results with digital health interventions for chronic conditions, suggesting potential success for this novel approach in breast cancer care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (18 years or older) diagnosed with breast cancer of stage I, II or III from 1st September 2023 or later * Have been prescribed adjuvant endocrine therapy for breast cancer. * Understands written and spoken Icelandic or English. * Owns a smart-phone compatible with the Sidekick app and capable to use it * Willing to download the Sidekick app on the smart-phone and to comply with the study measures and visits according to the protocol. * Capable of providing informed consent for participating in the study. Exclusion Criteria: * Having other concurrent conditions that in the opinion of the oncologist may compromise patient safety or study objectives. * Concurrent participation in another clinical study in which the study treatment may confound the evaluation of the investigational program. * Metastatic breast cancer (stage IV) * Previous experience with Sidekick breast cancer program
Where this trial is running
Reykjavik
- Landspitali University Hospital — Reykjavik, Iceland (Recruiting)
Study contacts
- Principal investigator: Olof Kristjana Bjarnadottir, MD, PhD — Landspitali University Hospital
- Study coordinator: Sigridur Lara Gudmundsdottir, PhD
- Email: siggalara@sidekickhealth.com
- Phone: +3546114475
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.