Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for 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 is a randomized, controlled study to assess the effect of Sidekick Health's digital program on self-efficacy and medication adherence in breast cancer patients prescribed adjuvant anti-hormonal treatment. Participants will be treated with the digital program in addition to standard of care (SoC), or SoC only.

Sidekick Health has developed a digital patient support tool delivered via mobile application (app), to support people who have been diagnosed with breast cancer with self-efficacy in managing their symptoms and with medication adherence and holistic lifestyle modification. The Sidekick platform includes a medication center, including behavioral change material and tools aimed at improving adherence.

The study will be a 2-arm, parallel-group, randomized (1:1) controlled trial to evaluate the performance of Sidekick's digital patient support program for patients with breast cancer on patients' self-efficacy and medication adherence in women undergoing adjuvant endocrine treatment. 140 participants will be included, and eligible participants will be randomized to receive the Sidekick digital support program plus standard of care, or standard of care only.

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