A Digital Therapeutic Solution for Cancer Patients

NCT ID: NCT05801965

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2024-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Prostate Cancer Colorectal Cancer Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center prospective randomized open label pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

A digital solution for patients with Cancer

Intervention Type DEVICE

A digital program that provides holistic lifestyle intervention as well as disease education.

Standard of care for patients with Cancer

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Standard of care for patients with Cancer

Intervention Type OTHER

Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

A digital solution for patients with Cancer

A digital program that provides holistic lifestyle intervention as well as disease education.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Landspitali University Hospital

OTHER

Sponsor Role collaborator

Ljósið Cancer Rehabilitation Center

UNKNOWN

Sponsor Role collaborator

Sidekick Health

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Landspitali University Hospital

Reykjavik, , Iceland

Site Status

Ljósið Cancer Rehabilitation Center

Reykjavik, , Iceland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iceland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SKH-ONC-99-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oncotool for Cancer Medications
NCT03952312 COMPLETED NA