A Digital Therapeutic Solution for Cancer Patients

Sidekick Health

Status: Completed

Conditions: Lung Cancer; Cancer; Prostate Cancer; Colorectal Cancer

Treatments: Other: Standard of care for patients with Cancer; Device: A digital solution for patients with Cancer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05801965

SKH-ONC-99-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Digital intervention group

Experimental group

Description:

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.

Treatment:

Device: A digital solution for patients with Cancer

Other: Standard of care for patients with Cancer

Standard of care - control group

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care for patients with Cancer