Breast CancerNCT06989450
Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer
A study testing Sidekick digital patient support program for patients with breast cancer in people with Breast Cancer and Cancer, run by Sidekick Health at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer
- What is being tested?
- Sidekick digital patient support program for patients with breast cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIceland
- Study dates
- 31 May 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
Landspitali University Hospital
Reykjavik, 101
Soley Dilja Stefansdottir, Nurse, +3546218594, rannsoknskh@landspitali.is
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Cancer
- Being tested
- Sidekick digital patient support program for patients with breast cancer, Standard of care for breast cancer patients
- Keywords
- Cancer, Breast Cancer, Medication adherence, self-efficacy, lifestyle change, endocrine treatment, digital health application
- Medical subject headings
- Breast Neoplasms, Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sidekick digital patient support program for patients with breast cancerDevice
A digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support.
Standard of care for breast cancer patientsOther
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention group | Experimental | 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. Receives: Device: Sidekick digital patient support program for patients with breast cancer; Other: Standard of care for breast cancer patients |
| Standard of care - control group | Active comparator | 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. Receives: Other: Standard of care for breast cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from baseline
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start31 May 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, open-label, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidekick Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital, University of Iceland, Icelandic Research Center
- Responsible party
- Sponsor
- Investigators
- Olof Kristjana Bjarnadottir, MD, PhD, Principal investigator, Landspitali University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989450
- Sponsor's protocol ID
- BC-99-IS-002
- Other IDs
- VSN24-126
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06989450
- Acronym / sponsor ID
- BC-99-IS-002
- Conditions
- Breast Cancer, Cancer
- Keywords
- Cancer, Breast Cancer, Medication adherence, self-efficacy, lifestyle change, endocrine treatment, digital health application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sidekick HealthIndustry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital, University of Iceland, Icelandic Research Center
- Study start
- 31 May 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, prospective, open-label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Digital intervention group | Experimental | Device: Sidekick digital patient support program for patients with breast cancer, Other: Standard of care for breast cancer patientsParticipants 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 comparator | Other: Standard of care for breast cancer patientsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sidekick digital patient support program for patients with breast cancerA digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support. | Device | Digital intervention group |
| Standard of care for breast cancer patientsStandard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation | Other | Digital intervention group, Standard of care - control group |
Primary outcome
Self-efficacy and health education impact
Time frame: 12 weeks from baseline
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olof Kristjana Bjarnadottir, MD, PhD principal investigator
Landspitali University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sidekick digital patient support program for patients with breast cancer in people with Breast Cancer and Cancer, run by Sidekick Health at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sigridur Lara Gudmundsdottir, PhD (+3546114475, siggalara@sidekickhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy and health education impact (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.