NCT05459454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

May 25, 2025

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

July 5, 2022

Last Update Submit

May 20, 2025

Conditions

Breast Cancer

Keywords

breast cancerdigital solutionlifestyle changequality of lifedigital interventionside effectsmedication adherencephysical activity

Outcome Measures

Primary Outcomes (1)

  • Cancer-specific Quality of Life

    Difference in change in total score of the 30-item Quality of life Core Questionnaire (QLQ-C30) between the intervention and control groups. This 30-item questionnaire is composed of 28 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much", and 2 questions with a Likert scale of 7 options where 1 represents "very poor" to 7 "excellent". Scores on the QLQ-C30 range from 30 to 126, with a lower score representing a higher quality of life.

    14 weeks

Secondary Outcomes (11)

  • Breast cancer-specific Quality of Life

    14 weeks

  • Cancer related fatigue

    14 weeks

  • Depression, anxiety, and stress levels.

    14 weeks

  • Medication adherence in participants on antihormonal therapy.

    14 weeks

  • Weight

    14 weeks

  • +6 more secondary outcomes

Study Arms (2)

Digital intervention group

EXPERIMENTAL

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.

Device: A digital health program for patients with Breast Cancer

Standard of Care

NO INTERVENTION

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.

Interventions

A digital health program for patients with Breast CancerDEVICE

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.

Also known as: SK-421
Digital intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Landspitali University Hospital

Reykjavik, 104, Iceland

Location

Ljosið Cancer Rehabilitation Centre

Reykjavik, 104, Iceland

Location

MeSH Terms

Conditions

Breast NeoplasmsMedication AdherenceMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sigríður L Guðmundsdóttir, PhD

    Sidekick Health & University of Iceland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single-center prospective randomized open label pilot study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 15, 2022

Study Start

July 15, 2022

Primary Completion

October 1, 2023

Study Completion

April 1, 2024

Last Updated

May 25, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Anonymized IPD may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.

Locations

IC(2)