Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer
2 other identifiers
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
May 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
May 25, 2025
January 1, 2025
1.1 years
January 20, 2025
May 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-efficacy and health education impact
Difference in change in total score of the Health Education Impact Questionnaire (heiQ) between the intervention and control groups. The heiQ has 8 subscales and is composed of in total 42 questions with a Likert scale of 4 options where 1 represents "strongly disagree" to 4 "strongly agree". Scores on the heiQ range from 42 to 168, with a lower score representing a low impact on patient education.
12 weeks from baseline
Secondary Outcomes (12)
Medication adherence according to MARS-5 questionnaire
12 weeks from baseline
Self-efficacy and health-education impact after 24 weeks and 1 year
24 weeks and 1 year
Medication adherence after 24 weeks and 1 year according to MARS-5
24 weeks and 1 year
Adherence (PDC) to adjuvant endocrine treatment over 1 year
1 year
Medication persistence
1, 2, 3 and 5 years
- +7 more secondary outcomes
Study Arms (2)
Digital intervention group
EXPERIMENTALParticipants will be instructed to download Sidekick Health app and receive a code to access the digital intervention in addition to standard of care, as is defined for the control arm. The digital patient support program empowers self-efficacy as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. The Sidekick platform includes a medication center, which constitutes of behavioral change educational material and methods aimed at improving adherence. Beyond this, all participants in the interventional arm will also receive standard of care as defined for the control arm.
Standard of care - control group
ACTIVE COMPARATORThe participants in the control arm will receive standard-of-care treatment. Standard of care includes adjuvant breast cancer treatment and any optional cancer rehabilitation that is not delivered through a mobile application.
Interventions
A digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support.
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sidekick Healthlead
- Landspitali University Hospitalcollaborator
- University of Icelandcollaborator
- Icelandic Research Centercollaborator
Study Sites (1)
Landspitali University Hospital
Reykjavik, 101, Iceland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olof Kristjana Bjarnadottir, MD, PhD
Landspitali University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor will be blinded for group assignment at the primary analysis (at 12 weeks).
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2025
First Posted
May 25, 2025
Study Start
May 31, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
May 25, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
Anonymized Individual Participant Data may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.