CancerNCT05801965
A Digital Therapeutic Solution for Cancer Patients
A study testing A digital solution for patients with Cancer in people with Cancer and Prostate Cancer, run by Sidekick Health at 2 sites in Iceland.
Trial summary
This is a randomized, controlled trial to assess the feasibility of Sidekick Health's digital programs for cancer patients. Participants will be treated with standard of care (SoC) in combination with the digital programs, or SoC only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- A digital solution for patients with Cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesIceland
- Study dates
- 6 Apr 2023to 1 Sep 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (at least 18 years of age) diagnosed with cancer
- Has started active cancer treatment (chemotherapy, hormonal therapy, targeted therapy, immunotherapy, radiotherapy) during the study
- Cancer diagnosis (all stages), with a focus on prostate cancer, lung cancer, or colorectal cancer
- Understands verbal and written Icelandic or English
- Owning a smartphone compatible with the Sidekick Health app and capable of using it.
- Capacity to give informed consent
- Willing to comply with all scheduled visits, study interventions, and procedures
Who cannot join
- Pregnancy
- Surgeries in the last 4 weeks prior to participation in the study
- Surgeries planned during the 14-weeks intervention
- Not able to comply with study intervention or scheduled measures and visits, as assessed by oncologist
- Current breast cancer diagnosis
Trial locations and contacts
2 sites in 1 country.
Iceland2 sites
Landspitali University Hospital
Reykjavik, 101
Ljósið Cancer Rehabilitation Center
Reykjavik, 104
About this study
Official title: Sidekick Health Digital Therapeutic Solution for Cancer Patients: A Feasibility Randomized Controlled Trial
This is a randomized, controlled trial to assess the feasibility of Sidekick Health's digital programs for cancer patients. Participants will be treated with standard of care (SoC) in combination with the digital programs, or SoC only.
We will compare the effect of the digital programs in addition to SoC to SoC only, on the cancer-related quality of life (QoL), cancer-related fatigue, and side-effect management.
Read the detailed description
In line with the growing need to support cancer patients with lifestyle modifications, education and disease management, Sidekick Health developed 14-week digital programs addressing the specific needs of patients with cancers. In this study, the effect of adding the Sidekick's digital program to the standard of care (SoC) treatment for cancer patients will be assessed, with focus on prostate cancer, colorectal cancer and lung cancer. The digital programs investigated are a general oncology program (SK-411), or specific programs tailored for patients diagnosed with prostate cancer (PC-SK-451), colorectal cancer (CRC-SK-441), or lung cancer (LC-SK-431).
The study will be a single center feasibility study with an intervention group and a comparison group recruiting 84 cancer patients in active cancer treatment from Landspítali University Hospital. Patients will be randomized to receive either the SoC treatment alone or SoC with the addition of the digital program. Active cancer treatment is defined as chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or radiation therapy according to standard treatment guidelines.
- Conditions
- Cancer, Prostate Cancer, Colorectal Cancer, Lung Cancer
- Being tested
- A digital solution for patients with Cancer, Standard of care for patients with Cancer
- Keywords
- cancer, digital solution, lifestyle change, prostate cancer, quality of life, digital intervention, side effects, medication adherence, physical activity, colorectal cancer, lung cancer
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Lung 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 solution for patients with CancerDevice
Also called SK-411 - General Oncology Program; PC-SK-451 Prostate Cancer program; CRC-SK-441; Colorectal Cancer Program LC-SK-431; Lung Cancer Program
A digital program that provides holistic lifestyle intervention as well as disease education.
Standard of care for patients with CancerOther
Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
| 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 14-week digital intervention in addition to standard of care, as is defined for the control arm.
Beyond this, all participants in the interventional arm will also receive standard of care as defined for the control arm. Receives: Device: A digital solution for patients with Cancer; Other: Standard of care for patients with Cancer |
| Standard of care - control group | Active comparator | Participants in 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. Receives: Other: Standard of care for patients with Cancer |
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 European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) between the intervention and control groups.
The EORTC-QLQ-C30 is a 30-item questionnaire. It 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: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Secondary outcomes (13)
Cancer-related fatigue derived from the general cancer questionnaire subscale
Difference in change in fatigue related subscale (questions 10, 12 and 18) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) between the intervention and control groups.
The fatigue subscale consists of questions 10, 12, and 18 of EORTC-QLQ-C30. These 3 questions are scored on a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the fatigue subscale range from 3 to 12, with a low score representing a low level of fatigue.
Measured: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Cancer-related fatigue
Difference in change in the total score on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC-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 EORTC-QLQ-FA12 range from 12 to 48, with a lower score representing less fatigue.
Measured: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of prostate cancer patients
Difference in change in the scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Prostate Cancer (EORTC-QLQ-PR25) between the prostate cancer patients in the intervention and control groups.
The EORTC QLQ-PR25 questionnaire assesses symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer. It consists of 25 questions with a Likert scale of 4 options where 1 represents "not at all," to 4 "very." The questions included in the questionnaire are grouped into symptom scales (questions 1 to 19) and functional scales (questions 20-25).
For the EORTC QLQ-PR25 questionnaire, a higher score on the symptomatic scales means a greater severity of symptoms, while a higher score on question 20-22 and a lower score on questions 23-25 of the functional scales means a higher level of functioning.
Measured: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of lung cancer patients
Difference in change in the total score on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Lung Cancer (EORTC-QLQ-LC13) between the lung cancer patients in the intervention and control groups.
The EORTC-QLQ-LC13 is a 13-item questionnaire. It is composed of 13 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the EORTC-QLQ-LC13 range from 13 to 52, with a lower score representing a higher quality of life.
Measured: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of colorectal cancer patients
Difference in change in the total score on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer (EORTC-QLQ-CR29) between the colorectal cancer patients in the intervention and control groups.
The EORTC-QLQ-CR29 is a 29-item questionnaire. It is composed of 29 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much", with some of these questions specific for people with or without a stoma bag, and two specific questions for each sex. Scores on the EORTC-QLQ-CR29 range from 25 to 104 with a lower score (on all but one of the two specific questions for each sex) representing a higher quality of life.
Measured: Baseline, 14 , 26, and 38 weeks after inclusion in the study
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: Baseline and 14 weeks after inclusion in the study
Cancer- and treatment-specific side effects
Evaluate the difference in cancer- and treatment-specific side effects in the intervention group between baseline and end of intervention.
Side effects are measured through in-app patient reported outcomes (PROs): patients evaluate their symptoms, grading them on a scale of 1 to 10, where low scores indicate the mildest symptoms and high scores indicate the most severe symptoms.
Measured: Baseline and 14 weeks after inclusion in the study
Sleep, energy, and stress levels
Evaluate the difference in sleep, energy, and stress levels in the intervention group between base line and end of intervention.
Sleep, energy, and stress levels are measured through in-app patient reported outcomes (PROs). Patients score their sleep, energy, and stress levels, grading them on a scale of 1 to 10. Low scores indicate poor sleep quality, low energy levels, and low stress levels. High scores indicate good sleep quality, high energy levels, and stress levels.
Measured: Baseline and 14 weeks after inclusion in the study
Self-assessed health-related quality of life for health economic evaluation
Difference in change in total score of the self-assessed EuroQuol Five Dimension - Five Level (EQ-5D-5L) health questionnaire between the intervention and control groups 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: Baseline, 14 , 26, and 38 weeks after inclusion in the study
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.
The SEMCD covers several domains that are common across many chronic diseases, such as 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: Baseline and 14 weeks after inclusion in the study
User satisfaction in intervention group
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: 14 weeks
User retention
Percentage of participants that will complete the digital intervention (DTx) program. Where "complete" is defined as finishing 75% of program.
Measured: 14 weeks
User engagement
Percentage of participants that are active in the digital intervention (DTx) program. Where "active" is defined as visiting the app at least once per week.
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 posted6 Apr 2023
- Study start6 Apr 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center prospective randomized open label pilot study
- Masking
- None (open label)
- Enrolment
- 48 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801965
- Sponsor's protocol ID
- SKH-ONC-99-003
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2023
- 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
- Sidekick Health Digital Therapeutic Solution for Cancer Patients: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05801965
- Acronym / sponsor ID
- SKH-ONC-99-003
- Conditions
- Cancer, Prostate Cancer, Colorectal Cancer, Lung Cancer
- Keywords
- cancer, digital solution, lifestyle change, prostate cancer, quality of life, digital intervention, side effects, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sidekick HealthIndustry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital, Ljósið Cancer Rehabilitation Center
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Apr 2023 (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 trial to assess the feasibility of Sidekick Health's digital programs for cancer patients. Participants will be treated with standard of care (SoC) in combination with the digital programs, or SoC only.
We will compare the effect of the digital programs in addition to SoC to SoC only, on the cancer-related quality of life (QoL), cancer-related fatigue, and side-effect management.
Detailed description
In line with the growing need to support cancer patients with lifestyle modifications, education and disease management, Sidekick Health developed 14-week digital programs addressing the specific needs of patients with cancers. In this study, the effect of adding the Sidekick's digital program to the standard of care (SoC) treatment for cancer patients will be assessed, with focus on prostate cancer, colorectal cancer and lung cancer. The digital programs investigated are a general oncology program (SK-411), or specific programs tailored for patients diagnosed with prostate cancer (PC-SK-451), colorectal cancer (CRC-SK-441), or lung cancer (LC-SK-431).
The study will be a single center feasibility study with an intervention group and a comparison group recruiting 84 cancer patients in active cancer treatment from Landspítali University Hospital. Patients will be randomized to receive either the SoC treatment alone or SoC with the addition of the digital program. Active cancer treatment is defined as chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or radiation therapy according to standard treatment guidelines.
Study design
- Primary purpose
- Treatment
- 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 solution for patients with Cancer, Other: Standard of care for patients with CancerParticipants will be instructed to download 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 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 patients with CancerParticipants in 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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (at least 18 years of age) diagnosed with cancer
- Has started active cancer treatment (chemotherapy, hormonal therapy, targeted therapy, immunotherapy, radiotherapy) during the study
- Cancer diagnosis (all stages), with a focus on prostate cancer, lung cancer, or colorectal cancer
- Understands verbal and written Icelandic or English
- Owning a smartphone compatible with the Sidekick Health app and capable of using it.
Key exclusion criteria (5 listed)
- Pregnancy
- Surgeries in the last 4 weeks prior to participation in the study
- Surgeries planned during the 14-weeks intervention
- Not able to comply with study intervention or scheduled measures and visits, as assessed by oncologist
- Current breast cancer diagnosis
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 solution for patients with CancerAlso: SK-411 - General Oncology Program; PC-SK-451 Prostate Cancer program; CRC-SK-441; Colorectal Cancer Program LC-SK-431; Lung Cancer ProgramA digital program that provides holistic lifestyle intervention as well as disease education. | Device | Digital intervention group |
| Standard of care for patients with CancerStandard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center. | Other | Digital intervention group, Standard of care - control group |
Primary outcome
Cancer-specific Quality of Life
Time frame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Difference in change in total score of the 30-item European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) between the intervention and control groups. The EORTC-QLQ-C30 is a 30-item questionnaire. It 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.
13 secondary outcomes
Cancer-related fatigue derived from the general cancer questionnaire subscale
Time frame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Cancer-related fatigue
Time frame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of prostate cancer patients
Time frame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of lung cancer patients
Time frame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of colorectal cancer patients
Time frame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Depression, anxiety, and stress levels
Time frame: Baseline and 14 weeks after inclusion in the study
Cancer- and treatment-specific side effects
Time frame: Baseline and 14 weeks after inclusion in the study
Sleep, energy, and stress levels
Time frame: Baseline and 14 weeks after inclusion in the study
Self-assessed health-related quality of life for health economic evaluation
Time frame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Patients' disease related self-efficacy
Time frame: Baseline and 14 weeks after inclusion in the study
User satisfaction in intervention group
Time frame: 14 weeks
User retention
Time frame: 14 weeks
User engagement
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 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 solution for patients with Cancer in people with Cancer and Prostate 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 7 inclusion and 5 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: Baseline, 14 , 26, and 38 weeks after inclusion in the study). 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.