An interventional study of Sidekick digital patient support program for patients with breast cancer and Standard of care for breast cancer patients in Breast Cancer and Cancer, sponsored by Sidekick Health. Recruiting at 1 site in Iceland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Sidekick Health · Not applicable, Interventional, and Supportive care
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 140 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sidekick Health is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Sidekick digital patient support program for patients with breast cancer · Other: Standard of care for breast cancer patients
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.
Other: Standard of care for breast cancer patients
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
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.
Time frame: 12 weeks from baseline
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.
Time frame: 12 weeks from baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Medication persistence
Compare the difference between groups in the proportion of participants still taking antihormonal therapy after 1, 2, 3 and 5 years, based on data from the Icelandic Medicine Registry.
Time frame: 1, 2, 3 and 5 years
BMI
Group difference in Body Mass Index (BMI) calculated from self-reported weight and height at 12, 24 weeks and 1 year. BMI = weight (kg) ÷ height2 (meters)
Time frame: 12, 24 weeks and 1 year
Physical activity from IPAQ-SF
Group difference in self-reported physical activity according to IPAQ-SF at 12, 24 weeks and 1 year.
Time frame: 12, 24 weeks and 1 year
Endocrine treatment symptom management
Group difference in total score of Endocrine Therapy Symptoms from Endocrine Symptoms Questionnaire at 12, 24 weeks and 1 year The questionnaire is composed of 11 questions, where 10 are answered on a Likert scale of 4 options where 1 represents "not at all" to 4 "very much", and 1 question with a 2-option yes or no.
Time frame: 12, 24 weeks and 1 year
Work status questionnaire
Work status is a categorical variable representing participants' self-reported employment condition at each follow-up time point. This outcome will be used to assess potential group differences over time. No validation measurement tool is used, only questions regarding participant status. Work full time Work part-time 50-99% Work part-time, \<50% Not on the labor market And reason for not being on labor market or working part time Sick leave Disability Pension Unemployed Other
Time frame: 12, 24 weeks and 1 year
In app PRO on sleep, energy, stress, quality of life
One PRO that asks users to rate the quality of sleep, energy level, stress level and quality of life. The longitudinal change of in-app ePRO in the intervention group will be analysed for these parameters: * quality of sleep * energy levels * stress levels * quality-of-life thermometer
Time frame: 12 and 24 weeks
User satisfaction in intervention group by MAUQ
Scores in the mHealth App Usability Questionnaire (MAUQ) of the intervention group. The MAUQ is an 18-item questionnaire. It is composed of questions with Likert scales of 7 options where 1 represents "strongly disagree" to 7 "strongly agree". Scores on the MAUQ range from 18 to 126, with a higher score representing a higher usability.
Time frame: 12 weeks
Engagement, retention and overall activity in the digital intervention
Percentage of users that are active in the digital program, finish the program and engage with the content of the Sidekick digital Program
Time frame: 12 and 24 weeks
Plan to share: No — 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.
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