A Digital Solution for Breast Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: A digital health program for patients with Breast Cancer

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iceland
  • Reykjavik, Iceland, 104
    • Ljosið Cancer Rehabilitation Centre
  • Reykjavík, Iceland, 104
    • Landspitali University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: SK-421
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast cancer-specific Quality of Life	Difference in change in the total score of the 45-item Quality of life Breast Cancer Questionnaire (QLQ-BR45) between the intervention and control groups. This 45-item questionnaire is composed of 45 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-BR45 range from 45 to 180, with a lower score representing a higher quality of life.	14 weeks
Cancer related fatigue	Difference in change in the total score of the 12-item Quality of life Fatigue questionnaire (QLQ-FA12) between the intervention and control groups. This 12-item questionnaire assesses physical-, cognitive- and emotional fatigue, the questionnaire is composed of 12 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-FA12 range from 12 to 48, with a lower score representing less fatigue.	14 weeks
Depression, anxiety, and stress levels.	Difference in change in the total score of the 21-item Depression, Anxiety and Stress Scale (DASS21) questionnaire between the intervention and control group. Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much". The scores on the subscales range from 0 to 63, and low scores indicate a better mental health status.	14 weeks
Weight	Difference in change in weight in the intervention and control groups from baseline to 14 weeks. Weight is measured in kilograms.	14 weeks
Body composition	Difference in change in body composition in the intervention and control groups from baseline to 14 weeks. Changes in body composition (fat mass and lean mass), measured by InBody 770 Body Composition Analyzer. Fat mass and lean mass are both expressed as percentage (%).	14 weeks
Cardiorespiratory fitness	Difference in change in estimated maximum rate of oxygen the body is able to use during exercise (VO2 max) in the intervention and control groups from baseline to 14 weeks. VO2 max is assessed with the Åstrand ergometry test and is expressed as: mL oxygen/kilograms x minute.	14 weeks
Self-assessed health-related quality of life for health economic evaluation	Difference in change in total score of the EuroQuol Five Dimension - Five Level (EQ-5D-5L) health questionnaire in the intervention and control groups from baseline to 14 weeks. EQ-E5-5L scores range from -0.530 to 1, with higher scores indicating a better health status. A score of 1 indicates full health.	14 weeks
Patients' disease related self-efficacy	Difference in change in a 6-item Self-Efficacy for Managing Chronic Disease questionnaire (SEMCD) score between the intervention and control groups from baseline to 14 weeks. The SEMCD covers several domains that are common across many chronic diseases, symptom control, role function, emotional functioning and communicating with physicians. The SEMCD questionnaire is composed of 6 questions with Likert scales of 10 options where 1 represents "not at all confident" to 10 "totally confident". Scores on the SEMCD range from 6 to 60, with a higher score representing a higher self-efficacy.	14 weeks
User satisfaction in intervention group	Score in the MHealth App Usability Questionnaire (MAUQ) of intervention group. This 18-item questionnaire is composed of questions with Likert scales of 7 options where 1 represents "strongly disagree" to 7 "strongly agree". Scores on the MAUQ range from 18 to 126, with a higher score representing a higher usability.	14 weeks
User experience	Qualitative semi-structured interviews with a subset of participants in intervention group	14 weeks
Medication adherence in participants on antihormonal therapy.	Difference in self-assessed medication adherence between intervention and control group as measured by the 8-item Morisky Medication adherence Scale (MMAS-8). The MMAS-8 is an 8-item structured, self-reported medication adherence measure. The total scale has a range of 0 to 8, with <6 reflecting low adherence, 6 to <8 reflecting medium adherence, and 8 reflecting high adherence.	14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory objective: Blood pressure	Difference in change in blood pressure between the intervention and control group between baseline and 14 weeks. Blood pressure in millimeters of mercury (mmHg)	14 weeks
Exploratory objective: Total blood count	Difference in change in values between intervention and control group. Based on first and last blood measurement taken as part of Standard of Care during the study period. To measure: total blood count: white blood cells, red blood cells, platelets, all in count/Liter	14 weeks
Exploratory objective: Hemoglobin	Difference in change in values between intervention and control group. Based on first and last blood measurement taken as part of Standard of Care during the study period. To measure: hemoglobin concentration, in grams/Liter	14 weeks
Exploratory objective: Hematocrit	Difference in change in values between intervention and control group. Based on first and last blood measurement taken as part of Standard of Care during the study period. To measure: hematocrit, in % of blood volume	14 weeks
Exploratory objective: Blood serum marker	Difference in change in values between intervention and control group. Based on first and last serum blood measurement taken as part of Standard of Care during the study period. To measure: high-sensitivity C-reactive protein (hs-CRP), in milligram per liter (mg/L)	14 weeks
Exploratory objective: In-app patient-reported outcomes of stress levels, energy levels, and quality of sleep.	Patient-reported outcomes (PROs) of stress level, energy level, and sleep quality are each determined in-app by the patient on a visual analog scale from 1 (worst) to 10 (best), and users are prompted to report these on 3 separate days every week. Low scores indicate a bad outcome, high scores indicate a good outcome. The changes in these PROs over time will be correlated with the assessments from other outcomes (outcomes 1, 2, 3, 6, 7, 8) for outcome prediction and validation between in-app and clinical metrics.	14 weeks
Exploratory objective: Physical activity	Difference in change in physical activity based on objective measures by accelerometers (measured in meter per squared second [m/s2]) between 10 participants each of the intervention and control group.	14 weeks
Safety Objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes	Therapy discontinuation, and incidence of adverse events (AE) or serious adverse events (SAE) reportings due to participation in the digital intervention	14 weeks

Collaborators and Investigators

• Sponsor: Sidekick Health
• Collaborators: Landspitali University Hospital; Ljósið Cancer Rehabilitation Center
• Investigators: Principal Investigator: Sigríður L Guðmundsdóttir, PhD, Sidekick Health & University of Iceland

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; breast cancer; quality of life; lifestyle change; medication adherence; digital intervention; side effects; digital solution
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SK-421-BRCA; 22-090 (Icelandic Bioethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized IPD may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No