NCT05459454

A Digital Solution for Breast Cancer Patients

Sidekick Health Digital Health Program (SK-421) for Breast Cancer Patients: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Sidekick Health · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment. This pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population. Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital healthprogram.

Detailed description

Many cancer survivors do not achieve previous levels of function and report prolonged fatigue, cognitive limitations, depression, anxiety, sleep problems, pain, or sexual dysfunction for up to ten years after diagnosis. In addition to symptoms related to the cancer itself, most cancer treatments cause physical and psychosocial side-effects that can affect a patient's physical function, mental well-being, and overall quality of life (QoL). These treatment-related side effects are most prominent during treatment but can also persist long after completion of the treatment with some becoming chronic and others developing as late side effects. The European Society of Medical Oncology (ESMO) recommends encouraging patients towards adopting a healthy lifestyle including diet modification and exercise as well as addressing psychosocial needs. Sidekick Health developed a 14-week digital health program (SK-421) with patient support aiming to increase the health related quality of life of breast cancer patients and improve management of treatment-related side effects. The aim of this study is to assess the effectiveness of this digital health program when added to standard of care treatment. By comparing the effect of adding a digital solution to the standard of care with standard of care only, this study will investigate the impact of a holistic, digitally delivered health program on quality of life, physical activity, medication and treatment-related side effects. The main analysis is done after 14 weeks, with exploratory follow-up analysis at 26 and 38 weeks.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	A digital health program for patients with Breast Cancer	A digital solution that supports healthy lifestyle changes, provides disease and side effect education as well as daily tasks for patients diagnosed with breast cancer.

Timeline

• Start date: 2022-07-15
• Primary completion: 2023-10-01
• Completion: 2024-04-01
• First posted: 2022-07-15
• Last updated: 2025-05-25

Locations

2 sites across 1 country: Iceland