A Digital Therapeutic Solution for Cancer Patients

Trial Title: A Digital Therapeutic Solution for Cancer Patients

NCT ID: NCT05801965

Condition: Cancer
Prostate Cancer
Colorectal Cancer
Lung Cancer

Conditions: Official terms:
Prostatic Neoplasms
Colorectal Neoplasms

Conditions: Keywords:
cancer
digital solution
lifestyle change
prostate cancer
quality of life
digital intervention
side effects
medication adherence
physical activity
colorectal cancer
lung cancer

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Single-center prospective randomized open label pilot study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: A digital solution for patients with Cancer
Description: A digital program that provides holistic lifestyle intervention as well as disease education.
Arm group label: Digital intervention group

Other name: SK-411 - General Oncology Program; PC-SK-451 Prostate Cancer program; CRC-SK-441; Colorectal Cancer Program LC-SK-431; Lung Cancer Program

Intervention type: Other
Intervention name: Standard of care for patients with Cancer
Description: Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
Arm group label: Digital intervention group
Arm group label: Standard of care - control group

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Landspitali University Hospital

Address:
City: Reykjavik
Zip: 101
Country: Iceland

Facility:
Name: Ljósið Cancer Rehabilitation Center

Address:
City: Reykjavik
Zip: 104
Country: Iceland

Start date: April 6, 2023

Completion date: September 1, 2024

Lead sponsor:
Agency: Sidekick Health
Agency class: Industry

Collaborator:
Agency: Landspitali University Hospital
Agency class: Other

Collaborator:
Agency: Ljósið Cancer Rehabilitation Center
Agency class: Other

Source: Sidekick Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05801965