A Digital Therapeutic Solution for Cancer Patients
Sidekick Health Digital Therapeutic Solution for Cancer Patients: A Feasibility Randomized Controlled Trial
1 other identifier
interventional
48
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Apr 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedStudy Start
First participant enrolled
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedMay 25, 2025
March 1, 2024
1.4 years
March 24, 2023
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 14 , 26, and 38 weeks after inclusion in the study
Secondary Outcomes (13)
Cancer-related fatigue derived from the general cancer questionnaire subscale
Baseline, 14 , 26, and 38 weeks after inclusion in the study
Cancer-related fatigue
Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of prostate cancer patients
Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of lung cancer patients
Baseline, 14 , 26, and 38 weeks after inclusion in the study
Health-related quality of life of colorectal cancer patients
Baseline, 14 , 26, and 38 weeks after inclusion in the study
- +8 more secondary outcomes
Study Arms (2)
Digital intervention group
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
A digital program that provides holistic lifestyle intervention as well as disease education.
Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sidekick Healthlead
- Landspitali University Hospitalcollaborator
- Ljósið Cancer Rehabilitation Centercollaborator
Study Sites (2)
Landspitali University Hospital
Reykjavik, 101, Iceland
Ljósið Cancer Rehabilitation Center
Reykjavik, 104, Iceland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2023
First Posted
April 6, 2023
Study Start
April 6, 2023
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
May 25, 2025
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
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.