Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Pharmaceutical Solutions

All Drugs and Chemicals

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

Landspitali University Hospital

Ljósið Cancer Rehabilitation Center

Sidekick Health

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Obesity

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

Endocrine System Diseases

In the project, 33 women in the first group will receive "diet" intervention for 12 weeks, and 33 women in the second group will receive "diet and exercise combination" intervention.

Lifestyle change

This project aims to compare "diet" and "diet and exercise combination" interventions in obese women with polycystic ovary syndrome.

This project will be carried out in the Dokuz Eylül University Research and Application Hospital gynecology outpatient clinic between June 1, 2022 and June 1, 2024. The purpose of the project will be explained to women who meet the sampling criteria, and their informed consent will be obtained. A prospective and randomized comparison of "diet" and "diet and exercise combination" interventions, which are among the first-line treatment lifestyle changes recommended for PCOS, will be done. In the project, 33 women in the first group will receive "diet" intervention for 12 weeks, and 33 women in the second group will receive "diet and exercise combination" intervention. "Descriptive Characteristics Form" will be filled in for both groups, then at the beginning and at the end of the project, routine ultrasonography and laboratory test parameters for PCOS diagnosis criteria and menstrual cycle characteristics will be recorded, hirsutism score, alopecia score and acne level will be evaluated, the Utian Quality of Life Scale, Body Appreciation Scale, and the Short Form of the Oxford Happiness Questionnaire will be filled out. Body composition analysis will be performed in both groups at the beginning of the project, in the fourth and eighth weeks, and personal dietary recommendations will be given. Kitchen scales will be given to both groups to adapt to dietary recommendations and a mobile nutrition application will be used to record their diets. Person-specific exercise recommendations will be given to the second group at the beginning of the project, in the fourth and eighth weeks. In addition, women will be informed with a guide to behavioral changes specific to PCOS, which will be prepared specific to their group. Exercise parameters will be recorded by giving the same mobile application. Mobile nutrition application data will be collected via e-mail in the fourth, eighth and twelfth weeks of the project.

Lifestyle Change in Women With Polycystic Ovary Syndrome

A New Approach Intended for the Examination of "Diet" and "Diet and Exercise Combination" Interventions in Obese Women With Polycystic Ovary Syndrome

The unit of mIU/mL will be used for the change in FSH.

The unit of mIU/mL will be used for the change in LH.

The unit of pg/ml will be used for the change in E2.

The unit of nmol/L will be used for the change in SHBG.

Quality of life assessed by Utian Quality of Life Scale. This scale consists of five-point Likert type, 23 items and four sub-dimensions (health, emotional, sexual and occupational quality of life). The lowest score that can be obtained from the scale is 23, and the highest score is 115. An increase in the scale and sub-dimension scores indicates that the quality of life increases. The Cronbach Alpha coefficient of the scale is 0.88.

Satisfaction assessed by Body Satisfaction Scale. This scale is five-point Likert type. It consists of two factors, general body satisfaction and investment in body image, and nine items. High scores from the scale reflect high body satisfaction. The Cronbach Alpha coefficient of the scale is 0.87.

Changes in BMI will be evaluated using kg/m\^2.

Dokuz Eylul University

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Lung Neoplasms

Prostatic Neoplasms

Colorectal Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants will be instructed to download 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 participants in the interventional arm will also receive standard of care as defined for the control arm.

Participants in 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 program that provides holistic lifestyle intervention as well as disease education.

A digital solution for patients with Cancer

Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.

Standard of care for patients with Cancer

This is a randomized, controlled trial to assess the feasibility of Sidekick Health's digital programs for cancer patients. Participants will be treated with standard of care (SoC) in combination with the digital programs, or SoC only.

We will compare the effect of the digital programs in addition to SoC to SoC only, on the cancer-related quality of life (QoL), cancer-related fatigue, and side-effect management.

In line with the growing need to support cancer patients with lifestyle modifications, education and disease management, Sidekick Health developed 14-week digital programs addressing the specific needs of patients with cancers. In this study, the effect of adding the Sidekick's digital program to the standard of care (SoC) treatment for cancer patients will be assessed, with focus on prostate cancer, colorectal cancer and lung cancer. The digital programs investigated are a general oncology program (SK-411), or specific programs tailored for patients diagnosed with prostate cancer (PC-SK-451), colorectal cancer (CRC-SK-441), or lung cancer (LC-SK-431).

The study will be a single center feasibility study with an intervention group and a comparison group recruiting 84 cancer patients in active cancer treatment from Landspítali University Hospital. Patients will be randomized to receive either the SoC treatment alone or SoC with the addition of the digital program. Active cancer treatment is defined as chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or radiation therapy according to standard treatment guidelines.

A Digital Therapeutic Solution for Cancer Patients

Sidekick Health Digital Therapeutic Solution for Cancer Patients: A Feasibility Randomized Controlled Trial

Anonymized Individual Participant Data 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 European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) between the intervention and control groups.

The EORTC-QLQ-C30 is a 30-item questionnaire. It 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 fatigue related subscale (questions 10, 12 and 18) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) between the intervention and control groups.

The fatigue subscale consists of questions 10, 12, and 18 of EORTC-QLQ-C30. These 3 questions are scored on a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the fatigue subscale range from 3 to 12, with a low score representing a low level of fatigue.

Difference in change in the total score on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC-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 EORTC-QLQ-FA12 range from 12 to 48, with a lower score representing less fatigue.

Difference in change in the scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Prostate Cancer (EORTC-QLQ-PR25) between the prostate cancer patients in the intervention and control groups.

The EORTC QLQ-PR25 questionnaire assesses symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer. It consists of 25 questions with a Likert scale of 4 options where 1 represents "not at all," to 4 "very." The questions included in the questionnaire are grouped into symptom scales (questions 1 to 19) and functional scales (questions 20-25).

For the EORTC QLQ-PR25 questionnaire, a higher score on the symptomatic scales means a greater severity of symptoms, while a higher score on question 20-22 and a lower score on questions 23-25 of the functional scales means a higher level of functioning.

Difference in change in the total score on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Lung Cancer (EORTC-QLQ-LC13) between the lung cancer patients in the intervention and control groups.

The EORTC-QLQ-LC13 is a 13-item questionnaire. It is composed of 13 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the EORTC-QLQ-LC13 range from 13 to 52, with a lower score representing a higher quality of life.

Difference in change in the total score on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer (EORTC-QLQ-CR29) between the colorectal cancer patients in the intervention and control groups.

The EORTC-QLQ-CR29 is a 29-item questionnaire. It is composed of 29 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much", with some of these questions specific for people with or without a stoma bag, and two specific questions for each sex. Scores on the EORTC-QLQ-CR29 range from 25 to 104 with a lower score (on all but one of the two specific questions for each sex) representing a higher quality of life.

Evaluate the difference in cancer- and treatment-specific side effects in the intervention group between baseline and end of intervention.

Side effects are measured through in-app patient reported outcomes (PROs): patients evaluate their symptoms, grading them on a scale of 1 to 10, where low scores indicate the mildest symptoms and high scores indicate the most severe symptoms.

Evaluate the difference in sleep, energy, and stress levels in the intervention group between base line and end of intervention.

Sleep, energy, and stress levels are measured through in-app patient reported outcomes (PROs). Patients score their sleep, energy, and stress levels, grading them on a scale of 1 to 10. Low scores indicate poor sleep quality, low energy levels, and low stress levels. High scores indicate good sleep quality, high energy levels, and stress levels.

Difference in change in total score of the self-assessed EuroQuol Five Dimension - Five Level (EQ-5D-5L) health questionnaire between the intervention and control groups 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.

The SEMCD covers several domains that are common across many chronic diseases, such as 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.

Scores in the mHealth App Usability Questionnaire (MAUQ) of the intervention group.

The MAUQ is an 18-item questionnaire. It 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.

Percentage of participants that will complete the digital intervention (DTx) program. Where "complete" is defined as finishing 75% of program.

Percentage of participants that are active in the digital intervention (DTx) program. Where "active" is defined as visiting the app at least once per week.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Digital Solution for Breast Cancer Patients	NCT05459454	Breast Cancer	A digital healt...	18 Years -	Sidekick Health
Lifestyle Change in Women With Polycystic Ovary Syndrome	NCT05377021	Polycystic Ovar...	Lifestyle chang...	20 Years - 41 Years	Dokuz Eylul University
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

Spots Global Cancer Trial Database for lifestyle change