A Digital Solution for Breast Cancer Patients

Last updated: May 20, 2025
Sponsor: Sidekick Health
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

A digital health program for patients with Breast Cancer

Clinical Study ID

NCT05459454
SK-421-BRCA
22-090
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female adults diagnosed with breast cancer stage 1, 2, 3 or 4

  • Treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-,endocrine-, or radiotherapy.

  • Fluent in verbal and written Icelandic or English

  • Capacity to give informed consent

  • Capacity to operate a smartphone

Exclusion

Exclusion Criteria:

  • Not owning a smartphone compatible with the Sidekick Health app or not willing tohave it installed on their device

  • Not able to comply with study intervention/scheduled measures and visits, asassessed by oncologist

  • Pregnancy

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: A digital health program for patients with Breast Cancer
Phase:
Study Start date:
July 15, 2022
Estimated Completion Date:
April 01, 2024

Study 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.

Connect with a study center

  • Ljosið Cancer Rehabilitation Centre

    Reykjavik, 104
    Iceland

    Site Not Available

  • Ljosið Rehabilitation Centre

    Reykjavik, 104
    Iceland

    Active - Recruiting

  • Landspitali University Hospital

    Reykjavík, 104
    Iceland

    Site Not Available

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