Clinical trial NCT05801965: A Digital Therapeutic Solution for Cancer Patients
Official title: Sidekick Health Digital Therapeutic Solution for Cancer Patients: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
physical activity
colorectal cancer
lung cancer
Lead sponsor: Sidekick Health
Sponsor class: INDUSTRY
Collaborators: name: Landspitali University Hospital
name: Ljósið Cancer Rehabilitation Center
First posted: 2023-04-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center prospective randomized open label pilot study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cancer-specific Quality of Life
timeFrame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Secondary outcomes:
measure: Cancer-related fatigue derived from the general cancer questionnaire subscale
timeFrame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
measure: Cancer-related fatigue
timeFrame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
measure: Health-related quality of life of prostate cancer patients
timeFrame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
measure: Health-related quality of life of lung cancer patients
timeFrame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
measure: Health-related quality of life of colorectal cancer patients
timeFrame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
measure: Depression, anxiety, and stress levels
timeFrame: Baseline and 14 weeks after inclusion in the study
measure: Cancer- and treatment-specific side effects
timeFrame: Baseline and 14 weeks after inclusion in the study
measure: Sleep, energy, and stress levels
timeFrame: Baseline and 14 weeks after inclusion in the study
measure: Self-assessed health-related quality of life for health economic evaluation
timeFrame: Baseline, 14 , 26, and 38 weeks after inclusion in the study
measure: Patients' disease related self-efficacy
timeFrame: Baseline and 14 weeks after inclusion in the study
measure: User satisfaction in intervention group
timeFrame: 14 weeks
measure: User retention
timeFrame: 14 weeks
measure: User engagement
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital
city: Reykjavik
country: Iceland
facility: Ljósið Cancer Rehabilitation Center
Study officials:
References: