Breast CancerNCT05459454
A Digital Solution for Breast Cancer Patients
A study testing A digital health program for patients with Breast Cancer in people with Breast Cancer, run by Sidekick Health at 2 sites in Iceland.
Trial summary
Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- A digital health 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
- 64 participants
- Where
- 2 sitesIceland
- Study dates
- 15 Jul 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Female adults diagnosed with breast cancer stage 1, 2, 3 or 4
- Treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-, endocrine-, or radiotherapy.
- Fluent in verbal and written Icelandic or English
- Capacity to give informed consent
- Capacity to operate a smartphone
Who cannot join
- Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
- Not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Iceland2 sites
Landspitali University Hospital
Reykjavik, 104
Ljosið Cancer Rehabilitation Centre
Reykjavik, 104
About this study
Official title: Sidekick Health Digital Health Program (SK-421) for Breast Cancer Patients: a Pilot Study
Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment.
This pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population.
Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital healthprogram.
Read the detailed description
Many cancer survivors do not achieve previous levels of function and report prolonged fatigue, cognitive limitations, depression, anxiety, sleep problems, pain, or sexual dysfunction for up to ten years after diagnosis. In addition to symptoms related to the cancer itself, most cancer treatments cause physical and psychosocial side-effects that can affect a patient's physical function, mental well-being, and overall quality of life (QoL). These treatment-related side effects are most prominent during treatment but can also persist long after completion of the treatment with some becoming chronic and others developing as late side effects.
The European Society of Medical Oncology (ESMO) recommends encouraging patients towards adopting a healthy lifestyle including diet modification and exercise as well as addressing psychosocial needs.
Sidekick Health developed a 14-week digital health program (SK-421) with patient support aiming to increase the health related quality of life of breast cancer patients and improve management of treatment-related side effects.
The aim of this study is to assess the effectiveness of this digital health program when added to standard of care treatment. By comparing the effect of adding a digital solution to the standard of care with standard of care only, this study will investigate the impact of a holistic, digitally delivered health program on quality of life, physical activity, medication and treatment-related side effects. The main analysis is done after 14 weeks, with exploratory follow-up analysis at 26 and 38 weeks.
- Conditions
- Breast Cancer
- Being tested
- A digital health program for patients with Breast Cancer
- Keywords
- breast cancer, digital solution, lifestyle change, quality of life, digital intervention, side effects, medication adherence, physical activity
- Medical subject headings
- Breast Neoplasms, Medication Adherence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digital health program for patients with Breast CancerDevice
Also called SK-421
A digital solution that supports healthy lifestyle changes, provides disease and side effect education as well as daily tasks for patients diagnosed with breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention group | Experimental | Participants will be instructed to download the Sidekick Health app and receive a code to access the 14-week digital intervention in addition to standard of care, as is defined for the control arm.
Beyond this, all patients in the interventional arm will also receive standard of care as defined for the control arm. Receives: Device: A digital health program for patients with Breast Cancer |
| Standard of Care | No intervention | The control arm will receive standard of care treatment. Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-specific Quality of Life
Difference in change in total score of the 30-item Quality of life Core Questionnaire (QLQ-C30) between the intervention and control groups.
This 30-item questionnaire is composed of 28 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much", and 2 questions with a Likert scale of 7 options where 1 represents "very poor" to 7 "excellent". Scores on the QLQ-C30 range from 30 to 126, with a lower score representing a higher quality of life.
Measured: 14 weeks
Secondary outcomes (11)
Breast cancer-specific Quality of Life
Difference in change in the total score of the 45-item Quality of life Breast Cancer Questionnaire (QLQ-BR45) between the intervention and control groups.
This 45-item questionnaire is composed of 45 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-BR45 range from 45 to 180, with a lower score representing a higher quality of life.
Measured: 14 weeks
Cancer related fatigue
Difference in change in the total score of the 12-item Quality of life Fatigue questionnaire (QLQ-FA12) between the intervention and control groups.
This 12-item questionnaire assesses physical-, cognitive- and emotional fatigue, the questionnaire is composed of 12 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-FA12 range from 12 to 48, with a lower score representing less fatigue.
Measured: 14 weeks
Depression, anxiety, and stress levels.
Difference in change in the total score of the 21-item Depression, Anxiety and Stress Scale (DASS21) questionnaire between the intervention and control group.
Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much". The scores on the subscales range from 0 to 63, and low scores indicate a better mental health status.
Measured: 14 weeks
Medication adherence in participants on antihormonal therapy.
Difference in self-assessed medication adherence between intervention and control group as measured by the 8-item Morisky Medication adherence Scale (MMAS-8).
The MMAS-8 is an 8-item structured, self-reported medication adherence measure. The total scale has a range of 0 to 8, with <6 reflecting low adherence, 6 to <8 reflecting medium adherence, and 8 reflecting high adherence.
Measured: 14 weeks
Weight
Difference in change in weight in the intervention and control groups from baseline to 14 weeks.
Weight is measured in kilograms.
Measured: 14 weeks
Body composition
Difference in change in body composition in the intervention and control groups from baseline to 14 weeks.
Changes in body composition (fat mass and lean mass), measured by InBody 770 Body Composition Analyzer.
Fat mass and lean mass are both expressed as percentage (%).
Measured: 14 weeks
Cardiorespiratory fitness
Difference in change in estimated maximum rate of oxygen the body is able to use during exercise (VO2 max) in the intervention and control groups from baseline to 14 weeks.
VO2 max is assessed with the Åstrand ergometry test and is expressed as:
mL oxygen/kilograms x minute.
Measured: 14 weeks
Self-assessed health-related quality of life for health economic evaluation
Difference in change in total score of the EuroQuol Five Dimension - Five Level (EQ-5D-5L) health questionnaire in the intervention and control groups from baseline to 14 weeks.
EQ-E5-5L scores range from -0.530 to 1, with higher scores indicating a better health status. A score of 1 indicates full health.
Measured: 14 weeks
Patients' disease related self-efficacy
Difference in change in a 6-item Self-Efficacy for Managing Chronic Disease questionnaire (SEMCD) score between the intervention and control groups from baseline to 14 weeks.
The SEMCD covers several domains that are common across many chronic diseases, symptom control, role function, emotional functioning and communicating with physicians.
The SEMCD questionnaire is composed of 6 questions with Likert scales of 10 options where 1 represents "not at all confident" to 10 "totally confident". Scores on the SEMCD range from 6 to 60, with a higher score representing a higher self-efficacy.
Measured: 14 weeks
User satisfaction in intervention group
Score in the MHealth App Usability Questionnaire (MAUQ) of intervention group.
This 18-item questionnaire 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: 14 weeks
User experience
Qualitative semi-structured interviews with a subset of participants in intervention group
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Jul 2022
- Primary completion1 Oct 2023
- Study completion1 Apr 2024
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 randomized open label pilot study
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidekick Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital, Ljósið Cancer Rehabilitation Center
- Responsible party
- Sponsor
- Investigators
- Sigríður L Guðmundsdóttir, PhD, Principal investigator, Sidekick Health & University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459454
- Sponsor's protocol ID
- SK-421-BRCA
- Other IDs
- 22-090
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2022
- 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 IPD 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
- Sidekick Health Digital Health Program (SK-421) for Breast Cancer Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT05459454
- Acronym / sponsor ID
- SK-421-BRCA
- Conditions
- Breast Cancer
- Keywords
- breast cancer, digital solution, lifestyle change, quality of life, digital intervention, side effects, medication adherence, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sidekick HealthIndustry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital, Ljósið Cancer Rehabilitation Center
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 15 Jul 2022 (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.
Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment.
This pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population.
Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital healthprogram.
Detailed description
Many cancer survivors do not achieve previous levels of function and report prolonged fatigue, cognitive limitations, depression, anxiety, sleep problems, pain, or sexual dysfunction for up to ten years after diagnosis. In addition to symptoms related to the cancer itself, most cancer treatments cause physical and psychosocial side-effects that can affect a patient's physical function, mental well-being, and overall quality of life (QoL). These treatment-related side effects are most prominent during treatment but can also persist long after completion of the treatment with some becoming chronic and others developing as late side effects.
The European Society of Medical Oncology (ESMO) recommends encouraging patients towards adopting a healthy lifestyle including diet modification and exercise as well as addressing psychosocial needs.
Sidekick Health developed a 14-week digital health program (SK-421) with patient support aiming to increase the health related quality of life of breast cancer patients and improve management of treatment-related side effects.
The aim of this study is to assess the effectiveness of this digital health program when added to standard of care treatment. By comparing the effect of adding a digital solution to the standard of care with standard of care only, this study will investigate the impact of a holistic, digitally delivered health program on quality of life, physical activity, medication and treatment-related side effects. The main analysis is done after 14 weeks, with exploratory follow-up analysis at 26 and 38 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center prospective randomized open label pilot study
| Arm | Type | Receives |
|---|---|---|
| Digital intervention group | Experimental | Device: A digital health program for patients with Breast CancerParticipants will be instructed to download the Sidekick Health app and receive a code to access the 14-week digital intervention in addition to standard of care, as is defined for the control arm. Beyond this, all patients in the interventional arm will also receive standard of care as defined for the control arm. |
| Standard of Care | No intervention | –The control arm will receive standard of care treatment. Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female adults diagnosed with breast cancer stage 1, 2, 3 or 4
- Treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-, endocrine-, or radiotherapy.
- Fluent in verbal and written Icelandic or English
- Capacity to give informed consent
- Capacity to operate a smartphone
Key exclusion criteria (3 listed)
- Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
- Not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist
- Pregnancy
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 |
|---|---|---|
| A digital health program for patients with Breast CancerAlso: SK-421A digital solution that supports healthy lifestyle changes, provides disease and side effect education as well as daily tasks for patients diagnosed with breast cancer. | Device | Digital intervention group |
Primary outcome
Cancer-specific Quality of Life
Time frame: 14 weeks
Difference in change in total score of the 30-item Quality of life Core Questionnaire (QLQ-C30) between the intervention and control groups. This 30-item questionnaire is composed of 28 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much", and 2 questions with a Likert scale of 7 options where 1 represents "very poor" to 7 "excellent". Scores on the QLQ-C30 range from 30 to 126, with a lower score representing a higher quality of life.
11 secondary outcomes
Breast cancer-specific Quality of Life
Time frame: 14 weeks
Cancer related fatigue
Time frame: 14 weeks
Depression, anxiety, and stress levels.
Time frame: 14 weeks
Medication adherence in participants on antihormonal therapy.
Time frame: 14 weeks
Weight
Time frame: 14 weeks
Body composition
Time frame: 14 weeks
Cardiorespiratory fitness
Time frame: 14 weeks
Self-assessed health-related quality of life for health economic evaluation
Time frame: 14 weeks
Patients' disease related self-efficacy
Time frame: 14 weeks
User satisfaction in intervention group
Time frame: 14 weeks
User experience
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No. Anonymized IPD 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. This study is not recruiting at the moment.
Sigríður L Guðmundsdóttir, PhD principal investigator
Sidekick Health & University of Iceland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A digital health program for patients with Breast Cancer in people with Breast Cancer, run by Sidekick Health at 2 sites 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 5 inclusion and 3 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: finished, 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-specific Quality of Life (time frame: 14 weeks). 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.