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.
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
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
Parallel
Sidekick digital patient support program for patients with breast cancer
DeviceA digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support.
Standard of care for breast cancer patients
Other interventionStandard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
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.
Medication adherence according to MARS-5 questionnaire
Group difference in self-reported adherence according to MARS-5 questionnaire at 12 weeks The MARS-5 questionnaire consists of five questions measuring adherence ranging from "never" (5 points) to "always" (1 points), therefore the score has a range from 5 - 25 points with higher score indicating high medication adherence.
Self-efficacy and health-education impact after 24 weeks and 1 year
Group differences in self-efficacy measured by eight scales of Health Education Impact Questionnaire (heiQ) at 24 weeks and 1 year.
Medication adherence after 24 weeks and 1 year according to MARS-5
Group difference in self-reported adherence according to MARS-5 questionnaire after 24 weeks and 1 year.
Adherence (PDC) to adjuvant endocrine treatment over 1 year
Adherence to adjuvant endocrine breast cancer treatment over 1 year based on percentage of days covered (PDC) from data from the Icelandic Medicine Registry. The proportion of days covered (PDC) is used to estimate medication adherence by looking at the proportion of days in which a person has access to the medication, over a given period of interest, in this case 1 year.
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Sidekick Health
Lead sponsor
Landspitali University Hospital
Collaborator
University of Iceland
Collaborator
Icelandic Research Center
Collaborator