Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2023-04-06
2024-09-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Digital intervention group
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.
A digital solution for patients with Cancer
A digital program that provides holistic lifestyle intervention as well as disease education.
Standard of care for patients with Cancer
Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
Standard of care - control group
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.
Standard of care for patients with Cancer
Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
Interventions
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A digital solution for patients with Cancer
A digital program that provides holistic lifestyle intervention as well as disease education.
Standard of care for patients with Cancer
Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Landspitali University Hospital
OTHER
Ljósið Cancer Rehabilitation Center
UNKNOWN
Sidekick Health
INDUSTRY
Responsible Party
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Locations
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Landspitali University Hospital
Reykjavik, , Iceland
Ljósið Cancer Rehabilitation Center
Reykjavik, , Iceland
Countries
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Other Identifiers
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SKH-ONC-99-003
Identifier Type: -
Identifier Source: org_study_id
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