NCT05801965

A Digital Therapeutic Solution for Cancer Patients

Sidekick Health Digital Therapeutic Solution for Cancer Patients: A Feasibility Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sidekick Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Prostate Cancer
• Colorectal Cancer
• Lung Cancer

Interventions

Type	Name	Description
DEVICE	A digital solution for patients with Cancer	A digital program that provides holistic lifestyle intervention as well as disease education.
OTHER	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.

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-04-06
• Last updated: 2025-05-25

Locations

2 sites across 1 country: Iceland