Clinical trial NCT05459454: A Digital Solution for Breast Cancer Patients
Official title: Sidekick Health Digital Health Program (SK-421) for Breast Cancer Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
digital solution
lifestyle change
quality of life
digital intervention
side effects
medication adherence
physical activity
Lead sponsor: Sidekick Health
Sponsor class: INDUSTRY
Collaborators: name: Landspitali University Hospital
name: Ljósið Cancer Rehabilitation Center
First posted: 2022-07-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center prospective randomized open label pilot study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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 Criteria:

* Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
* Not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist
* Pregnancy

Primary outcomes:
measure: Cancer-specific Quality of Life
timeFrame: 14 weeks
Secondary outcomes:
measure: Breast cancer-specific Quality of Life
timeFrame: 14 weeks
measure: Cancer related fatigue
timeFrame: 14 weeks
measure: Depression, anxiety, and stress levels.
timeFrame: 14 weeks
measure: Medication adherence in participants on antihormonal therapy.
timeFrame: 14 weeks
measure: Weight
timeFrame: 14 weeks
measure: Body composition
timeFrame: 14 weeks
measure: Cardiorespiratory fitness
timeFrame: 14 weeks
measure: Self-assessed health-related quality of life for health economic evaluation
timeFrame: 14 weeks
measure: Patients' disease related self-efficacy
timeFrame: 14 weeks
measure: User satisfaction in intervention group
timeFrame: 14 weeks
measure: User experience
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Ljosið Cancer Rehabilitation Centre
city: Reykjavík
country: Iceland
facility: Landspitali University Hospital
Study officials:
affiliation: Sidekick Health & University of Iceland
name: Sigríður L Guðmundsdóttir, PhD
role: PRINCIPAL_INVESTIGATOR
References: