Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer
NCT ID: NCT06989450
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2025-05-31
2026-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Digital intervention group
Participants 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.
Sidekick digital patient support program for patients with breast cancer
A digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support.
Standard of care for breast cancer patients
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
Standard of care - control group
The 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.
Standard of care for breast cancer patients
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
Interventions
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Sidekick digital patient support program for patients with breast cancer
A digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support.
Standard of care for breast cancer patients
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Landspitali University Hospital
OTHER
University of Iceland
OTHER
Icelandic Research Center
UNKNOWN
Sidekick Health
INDUSTRY
Responsible Party
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Principal Investigators
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Olof Kristjana Bjarnadottir, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Landspitali University Hospital
Locations
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Landspitali University Hospital
Reykjavik, , Iceland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VSN24-126
Identifier Type: OTHER
Identifier Source: secondary_id
BC-99-IS-002
Identifier Type: -
Identifier Source: org_study_id
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