Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2022-07-15
2024-04-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Digital intervention group
Participants will be instructed to download the 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 patients in the interventional arm will also receive standard of care as defined for the control arm.
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.
Standard of Care
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 able to comply with study intervention/scheduled measures and visits, as assessed by oncologist
* Pregnancy
18 Years
FEMALE
No
Sponsors
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Landspitali University Hospital
OTHER
Ljósið Cancer Rehabilitation Center
UNKNOWN
Sidekick Health
INDUSTRY
Responsible Party
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Principal Investigators
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Sigríður L Guðmundsdóttir, PhD
Role: PRINCIPAL_INVESTIGATOR
Sidekick Health & University of Iceland
Locations
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Landspitali University Hospital
Reykjavik, , Iceland
Ljosið Cancer Rehabilitation Centre
Reykjavik, , Iceland
Countries
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Other Identifiers
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22-090
Identifier Type: OTHER
Identifier Source: secondary_id
SK-421-BRCA
Identifier Type: -
Identifier Source: org_study_id
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