Behaviors and Mental Disorders

All Conditions

Neoplasms

Symptoms and General Pathology

Nervous System Diseases

Depression

Neoplasm Metastasis

Back Pain

Low Back Pain

Depressive Disorder

Pain

Neurologic Manifestations

The assigned participants will receive an intervention based on gamification and the use of behavior change techniques to reduce sedentary lifestyle. Thus, a new mobile application will be used for 12 weeks that proposes to the user the realization of activities with the aim of reducing their sedentary behavior. The development of the application is based on previous analyzes that propose 6 clusters that encompass 33 factors that influence sedentary behavior. In this way, the application is designed to act on the two accessible: social support and behavior. On the social support, he proposes to the user to share his achievements in social networks or in an internal network of game users. In terms of habit modification, behavior modification strategies proposed in the Michie et al. (2013) taxonomy are applied, such as the following: establishment of personalized goals, rewards and reminders, awareness of achievements achieved, among others

The control group will receive the usual indications about the harms of sedentary lifestyle and the benefits of physical activity, not receiving specific intervention. In case the use of the intervention applied in the experimental group is beneficial, the participants assigned to the control group will be offered the opportunity to receive the intervention outside the study to allow the benefit to be used.

The information group will receive through a mobile application tips to reduce sedentary lifestyle and promote healthy living habits.

Digital intervention

The objective of the project is to analyze the clinical effectiveness of a gamifield mHealth application (iGAME) and developed in the context of lifestyle modification, but with the approach of the Behaviour Change Technique, through a randomized clinical trial that affects secondary prevention in three clinical subtypes of noncommunicable diseases, where lifestyle modification is the center of its best practice.

Despite digital exposure, gamification of health has been widely understood and often applied ad hoc in health products. Attempts to incorporate game concepts into digital health applications have not led to demonstrated success. Recent studies have shown that only 4% of the best rated health apps in Apple stores and Google Play (based on revenue and download) have gamification elements, but less than 5% of these health apps have been included in the application library of National Health Service. In addition, very little of 5% was developed for industry and health professionals.

If the power of digital technologies, such as games for clear clinical benefits, is not released, opportunities for social and economic burial will be lost for all stakeholders in the digital health and digital economy ecosystem.

A number of factors in this barrier:

* The best techniques for the design of activities. The majority of health gamification has little consistent support of health or clinical theories.
* The high cost and complexity of the digital game development process. The majority of gaming functions are based on best practices in the development of digital games.
* Little participation of researchers in health, professionals and participation of the end user in the process of gamification development. Very little health gamification is formally evaluated clinically.

The initial hypothesis is that after 12 weeks of participation in the original iGAME application, participants will increase the quantity and distribution of energy consumption, through the estimation of results, data based on acceleration and questionnaires. automatic information In addition, it will also improve satisfaction and lifestyle, as well as the consumption of health services.

Two groups study. One group with intervention (app mobile program); second group as control. At the end of the intervention, the control group receives advice of demonstrated effectiveness in the intervention to comply with the ethical principles.

The system of randomization for the participants is through an external computer system.

Digital Intervention for the Modification of Lifestyles (iGame)

Effectiveness of a Digital Intervention Based on Modification of Lifestyles in Secondary Prevention: iGAME Controlled Randomized Clinical Trial

The results emerging from this study are positive, negative or inconclusive with respect to the proposed hypothesis, these will be attempted to publish as scientific production in journals of high impact in the area of knowledge and indexed in Journal Citation Reports of ISI-Thompson, preferably of the 1-2th quartile. In addition, we will try to select Open Acess journals to favor the scientific dissemination of the results. In the same way, the results will be exposed in communications, papers, forums and discussion tables of different scientific and cultural days.

Patient reported outcome: Physical activity related to a person's health

Patient reported outcome. It is an evaluation of sedentary behavior. An alternative way to the use of accelerometry for the calculation of energy consumption.

Patient reported outcome. Health index that relates quantity and quality of life. It is applied with a short questionnaire and a visual analogue scale. Each dimension is rated in five levels from 1 ("I have no problem with...") to 5 ("I am unable to..."). Each participant indicates the level that best reflects their state for each of the five dimensions, with which their health status is described by five digits that take values from 1 to 5, with health status 11111 being considered a priori the best state of health and 55555 the worst state of health. The visual analogue scale is scored from 0 (without pain) to 100 (worst pain).

Patient reported outcome: tool designed to assess patient satisfaction with physiotherapy care through intrinsic and extrinsic factors. The instrument consists of 10 specific items and 2 global items scored from 1 (strongly disagree) to 5 (strongly agree). The means of items 1 through 3 and 4 through 10 are calculated to determine the mean score for external and internal subscales, respectively. Total score from 0 (worst patient satisfaction) to 5 (best patient satisfaction).

Patient reported outcome:Questionnaire designed to evaluate cancer-related fatigue in breast cancer survivors. Composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue: behavioral/severity, affective meaning, sensory and cognitive/mood. To calculate the total fatigue score, add the 22-item scores together and divide by 22 in order to keep the score on the same numeric "0" to "10" scale. Severity codes: 0 none, 1-3 mild, 4-6 moderate, 7-10 severe.

Patient reported outcome: quantification of existing fear-avoidance components in patients with medical conditions associated with pain. 20 question related to painful medical condition. 5 = Completely Agree 4 = Mostly Agree 3 = Slightly Agree 2 = Slightly Disagree 1 = Mostly Disagree0 = Completely Disagree. Higher values represent a worse outcome.

patient reported outcome. Assessment the degree of physical disability related to non-specific low back pain, understanding physical disability as limitation in the performance of activities of daily life.

Patient reported outcome.Assessment the functionality of the column as a whole

Brief structured diagnostic interview to generate diagnoses DSM-IV and ICD-10

Patient reported outcome. Assessment the presence and severity of depressive symptoms, relating to the last days of the previous week.

Horizon 2020 - European Commission

University of Malaga

Principal Research

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Diabetes Mellitus

Prediabetic State

Glucose Intolerance

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Metformin

Insulin

Insulin, Globin Zinc

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease.

To begin week 12 for participants who remain prediabetic after 12 week lifestyle run-in. Dosage and Route of Administration: 500 mg dose/ day to be taken orally, increased to 1000 mg dose/ day at week 14 through week 24. The dose should be taken immediately following the evening meal and at approximately the same time daily

Lifestyle Change Digital Intervention - This is a digital platform that will include a core curriculum focused on diet, exercise, and behavioral strategies for goal setting and self-monitoring to improve diet including a weight loss On Day 1, participants will begin their digital lifestyle intervention using their smart-phone application with their lifestyle coach and peer group.

On day 14, participants will be contacted by phone (+/- 4 days, day 10 to 18) and adherence assessed using virtual pill counts via phone calls.

At weeks 4, 8, 16 and 20 a phone-based pill count for adherence and adverse event symptom log will be completed and study medication dispensed.

At week 12 (interim assessment) and 24 (study-end), the participant will return to St. Jude Children's Research Hospital (SJCRH) for an in-person assessment.

The digital lifestyle change program will complete at week 24.

Digital Intervention

Stephanie Dixon, MD, MPH

This is a first-in survivor, single-arm pilot study with the goal of establishing evidence of feasibility and safety of a combined pharmacologic (metformin) and lifestyle intervention (using an existing digital platform) to prevent diabetes in prediabetic adult survivors of childhood cancer.

Primary Objective

The primary aim of this proposal is to establish the feasibility and safety of a 24-week combined metformin + intensive lifestyle intervention among adult survivors with prediabetes (including a 12-week lifestyle alone run-in followed by 12-week combined intervention among survivors remaining prediabetic).

Primary endpoints of this trial will be adherence to 1) daily metformin administration and 2) completion of required core-curriculum of the lifestyle change intervention. Safety will be assessed using the Global Rating of Side Effects Burden

Secondary Objectives

The secondary aim is to assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on glycemic control and insulin resistance. Glycemic control will be measured by fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) and insulin resistance measured by the homeostatic model assessment (HOMA-IR) and IGF- binding protein 1 (IGF-BP1; a measure of insulin sensitivity strongly correlated with euglycemic insulin clamp testing).

Exploratory Objectives

To assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on weight, other anthropometric measures, blood pressure and lipid profile, physical activity (self-reported and as measured by accelerometer), frailty measures, and health-related quality of life (HRQOL). We will also assess diabetes development at future SJLIFE visits.

To assess measures of participation in the lifestyle change program as well as barriers to participation and medication adherence.

Eligible subjects who meet inclusion criteria will be enrolled in a 12 week run-in period of the digital lifestyle intervention program. At the 12 week study visit, those who remain prediabetic will received metformin extended release daily, first at lower dose (500 mg/day) to minimize gastrointestinal side effects (diarrhea, nausea, flatulence, bloating), then escalated to a maximum dose of 1000 mg/day at week 14. The digitally delivered lifestyle change program will include a core curriculum focused on diet quality, food types, exercise and behavioral strategies for goal setting, and self- monitoring.

The schema was changed the to an adaptive trial design with a 12 week lifestyle run-in followed by a combined metformin+lifestyle intervention for 12 weeks

An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Adherence to the intervention with 80% adherence to prescribed metformin and completion of 60% of the digitally-delivered core education curriculum through the lifestyle change platform.

Adherence will be monitored by completion logs of lessons

An Adverse Event Monitoring Log with Global Rating of Side Effects Burden

Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.

Glycemic Control will be measured by Change in Hemoglobin A1c

Glycemic Control will be measure by Change in Fasting Plasma Glucose

St. Baldrick's Foundation

Conquer Cancer Foundation

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

A mini program-based digital intervention.

This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

Shen Qu, Doctor

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.

Treating PCOS With Digital Intervention vs. Metformin

Treating Polycystic Ovarian Syndrome (PCOS) With Digital Intervention vs. Metformin

Assess physical activity situation in women with PCOS.

Assess sleep situation in women with PCOS.

To evaluate anxiety and depression in PCOS women.

Assess eating behavior in women with PCOS.

Shanghai 10th People's Hospital

Director, Principal Investigator, Clinical Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Half of participants will be provided with genetic pre-test information via the BRCA-DIRECT digital platform.

Half of participants will be provided with genetic pre-test information via the normal standard pathway - a telephone consultation with a Genetic Counsellor.

97.5% of participant's with a negative (normal) result will receive their BRCA-gene testing result via the BRCA-DIRECT digital platform.

2.5% of participants with a negative (normal) result and those with positive results will receive their BRCA-gene testing result via the normal standard pathway - a telephone consultation with a Genetic Counsellor.

Participants will receive a link to the digital pre-test information. This will consist of text covering: Genetics and cancer risk; Genetics testing; What will happen if your test is positive; What will happen if your test is negative; Implications for insurance.

Where relevant, parts of the text will be linked through to additional information, such as insurance advice from the Association of British Insurers. Participants will be able to call a genetic counsellor on the hotline during weekday office hours, should they have any questions or require further information.

Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform

Participants will receive a digital message that their results are available. When they click this, they will receive digital notification of their negative (normal) result in short form. Full details will be provided in an individualised letter.

Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform

Gareth Evans

Angela George

BRCA-DIRECT is a pragmatic, randomised, non-inferiority evaluation that aims to evaluate whether digital delivery of pre-test information for BRCA-testing in breast cancer patients is non-inferior to current standard practice of 1:1 delivery from a healthcare professional as measured by rate of uptake of the genetic testing.

Participants will be recruited via breast clinics in two oncology centres. Patients will be provided with a study pack containing information about the study. If in clinic, the patient can complete an expression of interest form and a saliva/blood sample will be stored until consent to the study is received. The consent form and saliva sample can be completed at home and sent to the study team.

On receipt of a signed study consent form, the local site will confirm the patient's eligibility and enter details required for study conduct onto the BRCA-DIRECT databases.

After 24 hours, the participant will be sent a link to the BRCA-DIRECT study platform interface. This link enables the participant to progress through the study or withdraw if they have changed their mind.

Participants will be randomised 1:1 to receive either:

1. Telephone consultation with a genetic counsellor (standard of care) The telephone consultations will be as per standard practice of the qualified genetic counsellor delivering the pre-test information.
2. Digital delivery of pre-test information via BRCA-DIRECT platform (intervention)

Participants will receive a link to the digital pre-test information. This will consist of text covering:

* Genetics and cancer risk
* Genetics testing
* What will happen if your test is positive
* What will happen if your test is negative
* Implications for insurance

All participants will have access to a Genetic Counsellor hotline at all stages of the process.

For both arms, if a participant decides to proceed with the genetic test they will sign a digital 'BRCA-test consent' form, which will be formatted to BSGM (British Society of Genomic Medicine) standards. All participants will receive a copy of their signed BRCA-test consent form via secure email/post. The participant will have two days following test-consent to reverse the decision to proceed with the BRCA-test. Beyond those two days, the test will proceed.

The laboratory testing is a standard UK NHS (National Health Service) genetic test. This is delivered for both the intervention arm and the standard-of-care arm.

Participants with a negative (normal) genetic test result will be randomised to receive results either digitally, or via telephone consultation with the Genetic Counsellor. Any individuals with a positive result will receive their result by telephone. Following delivery of results, a results letter and copy of the pathology report will be sent to the participant and their medical team.

The participants will be invited to complete Quality of Life questionnaires, a knowledge test and satisfaction survey at various time points throughout the study via the BRCA-DIRECT platform.

Participants are initially randomised 1:1 to receive genetic pre-test information either via the BRCA-DIRECT digital platform or a genetic counselling telephone appointment. Once the participants BRCA-gene test result becomes available, they are then randomised sequentially depending on the result of the genetic test. Participants with a negative (normal) result are randomised to receive this information either via the BRCA-DIRECT digital platform or a genetic counselling telephone appointment. Participants with a positive result will not be randomised and instead will always have a genetic counselling telephone appointment.

Digital Delivery of Information About Genetic Testing for Breast Cancer

BRCA-DIRECT: Randomised Evaluation in Women Diagnosed With Breast Cancer of Digitally-delivered Pre-test Information for BRCA-testing

Proportion of patients proceeding with the BRCA-gene test following receipt of pre-test information

Test participant knowledge following delivery of pre-test information via a Knowledge Questionnaire (study specific) of 12 True/False/Unsure questions for a total possible score of 12/12.

Participant Quality of Life Questionnaire scores collected before pre-test information and after test results received. The Spielberger state-trait anxiety inventory (STAI) consists of two self-administered, 20-item questionnaires, with each item rated on a four-point Likert scale. It assesses anxiety proneness (trait) and the current state of anxiety change (state). The Trait anxiety is measured only once before pre-test information, and the State at each time point. High STAI scores signify greater anxiety.

Potential participant decline on account of lack of digital access

To compare 'Test-offer-to-results' time of the BRCA-DIRECT digital model compared to an audit of timings under current pathways at participating centres

Evaluate proportion of patients receiving digital pre-test information who require 1:1 discussion via the helpline

Healthcare Professional Feedback Survey completion to evaluate how satisfied Healthcare professionals were with the BRCA-DIRECT digital model

Participant Satisfaction Survey (study specific) completion to evaluate how satisfied patients were with the BRCA-DIRECT digital model, consisting of 9 questions, of which 3 are ranked on a scale of 1-5 (1 - not satisfied to 5 - very satisfied) and others are multi-choice.

University of Sussex

University of Manchester

Cancer Research UK

Institute of Cancer Research, United Kingdom

Overweight

Obesity

Body Weight

Weight Loss

Body Weight Changes

Adolescent and young adult cancer survivors receive AYA Connect intervention.

Adolescent and young adult cancer survivors receive AYA Connect-PP intervention.

Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.

Participants will receive a smart scale, activity tracker, an individual kickoff videochat session with a health coach, and access to a mobile smartphone app that includes weekly behavioral lessons, dietary tracking log, daily weight-related behavioral goals, tailored feedback summaries, and in-app health-related messages.

AYA Connect intervention

Participants will receive lessons about positive psychology (PP) strategies, weekly goals for PP exercises, and in-app health-related messages that include reminders to practice PP exercises.

Positive Psychology (PP) intervention

Participants will receive weekly individual videochat sessions with a health coach.

Positive Psychology Plus (PP+) intervention

Molly Diamond, MPH

E., MPH

Carmina G. Valle, PhD, MPH

Carmina Valle, PhD

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program.

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of three adapted theory-based, mobile weight loss interventions delivered via a native smartphone application among AYAs: 1) AYA Connect; 2) AYA Connect enhanced with positive psychology strategies (AYA Connect-PP); and 3) AYA Connect enhanced with positive psychology strategies plus coaching (AYA Connect-PP+).

The 3-month interventions are aimed at promoting improvements in diet quality consistent with recommendations for cancer survivors, a decrease in energy intake, an increase in energy expenditure, modest weight loss, and an increase in positive affect. The 3-month interventions will be followed by a 3-month maintenance phase (no contact). Assessments will occur at baseline, 3 (post-intervention), and 6 months (maintenance). Weight will be collected via smart scales mailed to participants. Adherence measures will include daily self-monitoring of weight (smart scale), physical activity (activity tracker), and dietary intake (food log in AYA Connect app).

Young adults (n=60), ages 18-39, diagnosed with invasive malignancy between the ages of 15-39 years, post-cancer treatment, with body mass index (BMI) of 25-50 kg/m2 will be recruited from around the United States to participate in the pilot randomized trial. Participants will be randomized into one of three conditions: 1) AYA Connect intervention; 2) AYA Connect-PP intervention; and 3) AYA Connect-PP+ intervention.

Group 1: AYA Connect Intervention: These participants will receive a smart scale, activity tracker, an individual kickoff video chat session with a health coach, and access to a mobile smartphone app that includes weekly behavioral lessons, dietary tracking log, daily weight-related behavioral goals, tailored feedback summaries, and in-app health-related messages.

Group 2: AYA Connect-PP Intervention: In addition to the intervention components Group 1 will receive, these participants will also receive lessons about positive psychology (PP) strategies, weekly goals for PP exercises, and in-app health-related messages that include reminders to practice PP exercises.

Group 3: AYA Connect-PP+ Intervention: In addition to the intervention components Group 2 will receive, these participants also will receive weekly individual video chat sessions with a health coach.

Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

A Pilot Randomized Trial of a Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

Feasibility of interventions as measured by accrual rate will be calculated as the number of adolescent and young adult cancer (AYA) survivors who agreed to participate divided by the number of months of recruitment

Feasibility of interventions as measured by participation rate will be calculated as the number of participants who agreed to participate divided by the number of eligible AYA survivors.

Feasibility of interventions as measured by retention rate will be calculated as the number of AYA survivor participants who completed 3-month measures divided by the number who participated.

Retention rate at 6 months, calculated by the number of participants who completed all study measures at the 6-month time point divided by the number who participated.

Acceptability of the interventions will be measured by ratings of program acceptability and satisfaction. Participants will provide ratings on the helpfulness and difficulty of the program's behavioral goals (e.g., diet and physical activity goals) using an 8-point scale (1 = Not satisfied/Very difficult to 8 = Very satisfied/very easy). Additional questions will ask participants about the helpfulness of intervention features (e.g., lessons, feedback messages) for reaching their weight goals (1 = Not at all helpful to 4 = Extremely helpful). Higher scores indicate greater acceptability.

Number of days red foods (high-calorie, high-fat foods) are tracked, as measured by the food log data in the AYA Connect app. Participants will be asked to log their red foods in the app daily.

Number of days physical activity is tracked, as measured by activity tracker

Number of days weighed, as measured by smart scale

Change in weight, as measured by smart scale, from baseline to 3 and 6 months.

Change in energy intake (kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate energy intake.

Change in saturated fat intake (% kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24 The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate saturated fat intake.

Change in fruit and vegetable consumption (cups), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate average fruit and vegetable consumption.

Change in fiber consumption (g), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate fiber consumption.

Change in Healthy Eating Index (HEI) score, measured using the HEI and the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate HEI. HEI scores range from 0 to 100, with higher scores indicating greater adherence to the Dietary Guidelines for Americans.

Changes in weekly minutes of moderate-to-vigorous activity, computed from the participant's activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times.

Changes in daily steps, were computed from the participant's activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times.

Change in self-reported physical activity, measured using the Paffenbarger Activity Scale (PAQ). The PAQ provides an estimate of minutes per week of moderate-to-vigorous intensity, and calories/week of light (5 kcal/min), medium (7.5 kcal/min), and high (10 kcal/min) intensity activities. PAQ changes have been predictive of weight change.

Change in frailty index, measured using the FRAIL Questionnaire. The FRAIL Questionnaire assesses: 1) self-reported fatigue (1 item from Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health), 2) weight loss, 3) comorbidities (11 items from UNC Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Global Health), and 5) ability to overcome resistance (1 item from Medical Outcomes Study 36-Item Short Form). Positive responses for these components are summed to create the FRAIL index (range 0-5). A value \> 3 is considered frail, and a value of 2 is considered prefrail.

Change in health-related quality of life, measured using the Medical Outcomes Study 36-Item Short Form (SF-36) survey. This survey includes 36 items with eight subscales (physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions). Responses are coded on a scale of 0 to 100, where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score.

Change in depressive symptoms, measured by the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a self-report depression scale including 20 items that relate to depressive feelings and behaviors during the past week. Response options range from 0 (rarely or none of the time) to 3 (most or almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Change in anxiety symptoms, as measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). Possible scores range from 0 to 21, with higher scores reflecting greater symptom severity; cut-points of 5, 10, and 15 correspond to mild, moderate, and severe levels of anxiety.

Change in perceived stress, measured by the 10-item Perceived Stress Scale (PSS-10). PSS-10 measures overall perceived stress during the past month. Factor analysis supports a two-factor correlated model with perceived self-efficacy and perceived helplessness subscales.

Change in positive and negative affect, measured using the Positive and Negative Affect Schedule (PANAS). PANAS is a 20-item scale divided into two subscales to measure positive and negative affect. Each item is rated on a five-point Likert scale from 1 (very slightly or not at all) to 5 (extremely) and are summed to yield scores for each subscale.

UNC Lineberger Comprehensive Cancer Center

Quality of Life

Pharmaceutical Solutions

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.

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.

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.

A digital health program for patients with Breast Cancer

Sigríður L Guðmundsdóttir, PhD

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.

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.

Single-center prospective randomized open label pilot study

A Digital Solution for Breast Cancer Patients

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

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

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.

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.

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.

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.

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.

Difference in change in weight in the intervention and control groups from baseline to 14 weeks.

Weight is measured in kilograms.

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 (%).

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.

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.

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.

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.

Qualitative semi-structured interviews with a subset of participants in intervention group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Digital Intervention for the Modification of Lifestyles (iGame)	NCT04019119	Low Back Pain Oncology Depression Sedentary Lifes... Sedentary Behav...	Digital interve...	18 Years - 65 Years	University of Malaga
Digital Intervention for the Modification of Lifestyles (iGame)	NCT04019119	Low Back Pain Oncology Depression Sedentary Lifes... Sedentary Behav...	Digital interve...	18 Years - 65 Years	University of Malaga
An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer	NCT04742751	PreDiabetes Adult Children	Metformin Digital Interve...	18 Years - 44 Years	St. Jude Children's Research Hospital
Treating PCOS With Digital Intervention vs. Metformin	NCT05386706	Polycystic Ovar...	Digital Interve... Metformin	18 Years - 45 Years	Shanghai 10th People's Hospital
Digital Delivery of Information About Genetic Testing for Breast Cancer	NCT04842799	Breast Neoplasm...	Digital Deliver... Digital Deliver...	18 Years -	Institute of Cancer Research, United Kingdom
Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors	NCT06171945	Cancer Physical Activi... Cancer Survivor... Mental Health Obesity	AYA Connect int... Positive Psycho... Positive Psycho...	18 Years - 39 Years	UNC Lineberger Comprehensive Cancer Center
Treating PCOS With Digital Intervention vs. Metformin	NCT05386706	Polycystic Ovar...	Digital Interve... Metformin	18 Years - 45 Years	Shanghai 10th People's Hospital
A Digital Solution for Breast Cancer Patients	NCT05459454	Breast Cancer	A digital healt...	18 Years -	Sidekick Health
A Digital Therapeutic Solution for Cancer Patients	NCT05801965	Cancer Prostate Cancer Colorectal Canc... Lung Cancer	A digital solut... Standard of car...	18 Years -	Sidekick Health

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