Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sidekick digital patient support program for patients with breast cancer, Standard of care for breast cancer patients.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iceland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device 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. - Other Standard of care for breast cancer patients
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
Primary outcome measures
- Self-efficacy and health education impact [Time frame: 12 weeks from baseline]
Secondary outcome measures (12)
- Medication adherence according to MARS-5 questionnaire [Time frame: 12 weeks from baseline]
- Self-efficacy and health-education impact after 24 weeks and 1 year [Time frame: 24 weeks and 1 year]
- Medication adherence after 24 weeks and 1 year according to MARS-5 [Time frame: 24 weeks and 1 year]
- Adherence (PDC) to adjuvant endocrine treatment over 1 year [Time frame: 1 year]
- Medication persistence [Time frame: 1, 2, 3 and 5 years]
- BMI [Time frame: 12, 24 weeks and 1 year]
- Physical activity from IPAQ-SF [Time frame: 12, 24 weeks and 1 year]
- Endocrine treatment symptom management [Time frame: 12, 24 weeks and 1 year]
- Work status questionnaire [Time frame: 12, 24 weeks and 1 year]
- In app PRO on sleep, energy, stress, quality of life [Time frame: 12 and 24 weeks]
- User satisfaction in intervention group by MAUQ [Time frame: 12 weeks]
- Engagement, retention and overall activity in the digital intervention [Time frame: 12 and 24 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Iceland · 1 center
- Landspitali University Hospital — Reykjavik
Identifiers
NCT: NCT06989450 · BC-99-IS-002 · VSN24-126