A Digital Solution for Breast Cancer Patients
Study Details
Study Description
Brief Summary
Sidekick Health has developed an interactive digital therapeutic program (SK-421) specifically designed for reducing side effects in breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group recruiting 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment.
The 14-week pilot study will determine whether the interactive digital therapeutic 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 therapeutic program.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
The knowledge on the impact and importance of lifestyle modifications on cancer treatment related side-effects has increased and various guidelines for their use have been developed the structured implementation of this knowledge is still lacking. Finding convenient ways to incorporate lifestyle intervention to standard care could undoubtedly improve implementation of the lifestyle modification programs and consequently patients' QoL, physical function, medication adherence, and management of side effects.
Despite this knowledge, breast cancer patients often experience lack of support and sufficient information from health care providers regarding non-prescription methods for dealing with treatment side-effects. Patients themselves point out that easy access to information on side effects and how to manage them as well as an app to track and report side effects would be valuable tools to increase their feeling of being supported during and after cancer treatment.
Sidekick Health developed a 14-week digital therapeutic program (SK-421) with patient support to improve management of treatment-related side effects, increase medication adherence, increase quality of life, retain physical activity and fitness, and improve medical adherence in breast cancer patients.
The aim of this study is to assess the effectiveness of this digital therapeutic program. 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 lifestyle intervention and remote monitoring on quality of life, physical activity, medical adherence and treatment-related side effects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Digital intervention group Participants will be instructed to download a lifestyle-changing mobile application, and they will receive an access code to activate the breast cancer program to which they will have access for 12 months.The 14-week intervention program aims to support lifestyle changes by remote symptom monitoring, patient reported outcomes (PROs) and having participants enter data and answer questionnaires via the SidekickHealth platform, and to empower positive lifestyle changes. The program's objective is to empower self-assessment of symptoms as well as positive lifestyle change by gamification, altruistic rewards, and engaging content. Beyond this, all patients in the interventional arm will also receive standard of care as defined for the control arm. |
Device: A digital care solution for patients with Breast Cancer
A digital solution that provides remote symptom monitoring and support of healthy lifestyle changes by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed.
Other Names:
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| 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. |
Outcome Measures
Primary Outcome Measures
- Cancer-specific Quality of Life [14 weeks]
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.
Secondary Outcome Measures
- Breast cancer-specific Quality of Life [14 weeks]
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.
- Cancer related fatigue [14 weeks]
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.
- Depression, anxiety, and stress levels. [14 weeks]
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.
- Medication adherence in participants on antihormonal therapy. [14 weeks]
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 adherenece measure. Scores on the MMAS-8 range from 0-8, with 0 reflecting high adherence, 1-2 medium adherence and 3-8 low adherence.
- Weight [14 weeks]
Difference in change in weight in the intervention and control groups from baseline to 14 weeks. Weight is measured in kilograms.
- Body composition [14 weeks]
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 (%).
- Cardiorespiratory fitness [14 weeks]
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.
- Self-assessed health-related quality of life for health economic evaluation [14 weeks]
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.
- Patients' disease related self-efficacy [14 weeks]
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.
- User satisfaction in intervention group [14 weeks]
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.
- User experience [14 weeks]
Qualitative semi-structured interviews with a subset of participants in intervention group
Other Outcome Measures
- Exploratory objective: Blood pressure [14 weeks]
Difference in change in blood pressure between the intervention and control group between baseline and 14 weeks. Blood pressure in millimeters of mercury (mmHg)
- Exploratory objective: Total blood count [14 weeks]
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
- Exploratory objective: Hemoglobin [14 weeks]
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
- Exploratory objective: Hematocrit [14 weeks]
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
- Exploratory objective: Blood serum marker [14 weeks]
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)
- Exploratory objective: In-app patient-reported outcomes of stress levels, energy levels, and quality of sleep. [14 weeks]
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.
- Exploratory objective: Physical activity [14 weeks]
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.
- Safety Objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes [14 weeks]
Therapy discontinuation, and incidence of adverse events (AE) or serious adverse events (SAE) reportings due to participation in the digital intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female adults diagnosed with breast cancer stage 1, 2, 3 or 4
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Treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-, endocrine-, or radiotherapy.
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Fluent in verbal and written Icelandic or English
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Capacity to give informed consent
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Capacity to operate a smartphone
Exclusion Criteria:
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Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
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Not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ljosið Rehabilitation Centre | Reykjavik | Iceland | 104 |
Sponsors and Collaborators
- Sidekick Health
- Landspitali University Hospital
- Ljósið Cancer Rehabilitation Center
Investigators
- Principal Investigator: Sigríður L Guðmundsdóttir, PhD, Sidekick Health & University of Iceland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SK-421-BRCA