Clinical trial NCT06989450: Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer
Official title: Digital Patient Support Program for Self-Efficacy and Medication Adherence Amongst Women on Adjuvant Endocrine Treatment for Breast Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Cancer
Keywords: Cancer
Breast Cancer
Medication adherence
self-efficacy
lifestyle change
endocrine treatment
digital health application
Lead sponsor: Sidekick Health
Sponsor class: INDUSTRY
Collaborators: name: Landspitali University Hospital
name: University of Iceland
name: Icelandic Research Center
First posted: 2025-05-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, open-label, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Self-efficacy and health education impact
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Medication adherence according to MARS-5 questionnaire
timeFrame: 12 weeks from baseline
measure: Self-efficacy and health-education impact after 24 weeks and 1 year
timeFrame: 24 weeks and 1 year
measure: Medication adherence after 24 weeks and 1 year according to MARS-5
timeFrame: 24 weeks and 1 year
measure: Adherence (PDC) to adjuvant endocrine treatment over 1 year
timeFrame: 1 year
measure: Medication persistence
timeFrame: 1, 2, 3 and 5 years
measure: BMI
timeFrame: 12, 24 weeks and 1 year
measure: Physical activity from IPAQ-SF
timeFrame: 12, 24 weeks and 1 year
measure: Endocrine treatment symptom management
timeFrame: 12, 24 weeks and 1 year
measure: Work status questionnaire
timeFrame: 12, 24 weeks and 1 year
measure: In app PRO on sleep, energy, stress, quality of life
timeFrame: 12 and 24 weeks
measure: User satisfaction in intervention group by MAUQ
timeFrame: 12 weeks
measure: Engagement, retention and overall activity in the digital intervention
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital
Study officials:
affiliation: Landspitali University Hospital
name: Olof Kristjana Bjarnadottir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: