Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Fatigue

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients physical activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy.

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy.

The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps.

Patients receive a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided.

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.

Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C

Cihan Gani, MD, PD

Daniel Zips, MD, Prof

Cihan Gani, MD

This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.

This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in breast cancer patients on the fatigue syndrome during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented with the fatigue subscale of the FACIT Questionnaire three months after adjuvant radiotherapy.

Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer

Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)

This endpoint will be evaluated by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale of the FACIT questionnaire (Physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well being values 0-28, 28 better outcome; additional factors values 0-64, 64 worse outcome

University Hospital Tuebingen

Senior Physician

Participants prescribed moderate intensity aerobic exercise using their rating of perceived exertion (RPE) with a goal of sustaining an intensity level of 12 to 14 for their prescribed duration.

Participants prescribed moderate intensity aerobic exercise using personalised heartrate zones with a goal of sustaining an intensity level by maintaining their heartrate above 50 percent of their heartrate reserve level for their prescribed duration.

Participants prescribed moderate intensity aerobic exercise using personalised heartrate zones with a goal of sustaining an intensity level by maintaining their heartrate above 50 percent of their heartrate reserve level for their prescribed duration

Exercise to a Heart Rate (HR) Zone

Nigel JM Noor, MBChB

Becky Ward

Nigel JM Noor

Leanne Ashrafian

Krishna Moorthy

Prehabilitation is the use of exercise prior to surgery to improve peoples' fitness, which leads to improved outcomes of surgery. This service is now being run remotely, however, there is little existing evidence to support the best practice for this. Currently, baseline fitness is assessed remotely using either a sit to stand test or a step test. Once completed people are prescribed regular exercises and asked to exercise to a level of intensity using a measure called Rating of Perceived Exertion (RPE). However, these measurements may not be reliable. We are carrying out a study to assess if another waking test (modified Rockport test) and asking patients to exercise to a target heart rate are better measures of assessing baseline fitness and exercise intensity.

All participants will receive weekly telephone calls to check their progress and be provided with a wrist worn fitness tracker (Fitbit). Participants will be randomised to one of two groups. The only difference between the groups will be the way the exercise is prescribed. In one group participants will be asked to complete the exercises to an exercise level they find "somewhat hard". The other group will be asked to complete the exercises to maintain a set heart rate.

All participants will be asked to complete an activity log (submitted weekly) as an online form. A small group of people (maximum 10) will be asked if they would like to complete an in-person baseline fitness assessment also, this is optional.

This study runs for up to eight weeks with participation ending after eight weeks or at the time of surgery, whichever is sooner. In the final week of participation, participants will be asked to complete an online questionnaire about their experience of using a wearable fitness tracker during the prehabilitation programme.

Optimising patients pre-operatively or "Prehabilitation" is a relatively new and evolving concept in patient care. Prehabilitation utilises prescribed exercise in the time prior to surgery with the aim of improving a patient's functional capacity enabling them to better withstand the stress of surgery. 1-3 This is required due to the physiological insult cause by surgery, particularly in those with cancer, which in turn results in a decline in patients' function.

Post-operative restorative rehabilitation programmes such as Enhanced Recovery After Surgery (ERAS) are commonplace and used with the aim of returning the patients' function towards their preoperative baseline. ERAS has been shown to improve postoperative outcomes, including length of stay, re-admission, and complication rates.4 Prehabilitation has been shown to both improve cardiovascular fitness prior to surgery5,6 and like ERAS reduce post-operative complications.7,8 However, despite this and unlike ERAS, it's use is still patchy, with no national protocols in existence.

Due to evidence demonstrating its effectiveness, the benefits of commissioning prehabilitation services have been acknowledged in several surgical fields,9 with national policy documents from NHS England placing an emphasis on preventative rehabilitation, delivered before and during cancer treatment.10 As such, the policy environment could be seen as favourable. However, there is little evidence available, and significant heterogeneity in that which is available, for how best to approach a prehabilitation service to achieve the best results.

Physical activity is a core component seen across all reported prehabilitation programmes. However, heterogeneity is seen across multimodal programmes, meaning the type of exercise, duration and supervision of physical activity is inconsistently administered between studies. Additional interventions such as dietary support, psychological wellbeing and smoking cessation are also variably addressed in some studies.

Accurate, reliable, and reproducible assessment of cardiopulmonary fitness is required to effectively prescribe and monitor patients as they progress through a prehabilitation programme. Currently, cardiopulmonary fitness assessment requires patients to attend for in person assessment to undergo Maximal or Submaximal exercise testing.

WEARABLE ACTIVITY TRACKING AND EHEALTH TECHNOLOGIES IN HEALTHCARE

Wearable "fitness tracking" technologies incorporating sensors which monitor activity and physiological parameters are now pervasive and are a rapidly expanding commercial industry worldwide with a market size valuation of USD 37.10 billion in 2020, and a projected compound annual growth rate of 15.9% from 2020 to 2027.11 With significant investment in this technology leading to increasing functionality, reliability and aesthetics it opens up the potential for use in a healthcare setting where to date their use has already been shown to be both feasible and insightful in the perioperative setting.12 Intuitively, these devices could provide a beneficial aid in prehabilitation programmes. However, a literature review found no studies have yet reported the use of wearable technologies on patients when used within a prehabilitation programme.

eHealth technologies are defined as the cost-effective and secure use of information and communications technologies in support of health and health-related fields13. They are already widely used by patients with 72% of internet users saying they looked online for health information of one kind or another within the past year14 and 69% of adults regularly tracking a health indicator like weight, diet, exercise routine, or symptom15. Utilising eHealth technology within prehabilitation may help to improve patient participation, particularly in home-based programmes. The assessment of exercise intensity is one possible area in which it could be used to overcome the limitations of self-assessment. Making it easier for patients to assess intensity and monitor the frequency that they are achieving their target activity may improve exercise behaviour and consequently improve the response to prehabilitation.

RATIONALE FOR CURRENT STUDY

Using fitness trackers in prehabilitation opens up the potential for remote programmes whilst maintaining objective measurement of heart rate and step count. Remote prehabilitation programmes, as opposed to in person individual or group sessions within a hospital setting are attractive to patients, health professionals and policy makers alike. For patients, the distance from home and the physical and financial demands of travel can negatively impact accessibility of programmes and the time available to complete exercises. Particularly pertinent for those travelling long distances to tertiary centres for cancer treatment and more recently with the risks of COVID-19 to those clinically vulnerable. Therefore, reducing unnecessary hospital visits is desirable. Remote assessment makes scheduling easier for clinicians and the use of wearable fitness trackers provides a more detailed understanding of individual parameters over longer periods, rather than a snapshot. For policy makers, remote assessment means reduced clinic and or gym space required, therefore reducing costs and reduced footfall (a key target resulting from the covid-19 pandemic) within the hospital to facilitate other scheduling commitments. Whilst many perceived benefits exist, it is also necessary to acknowledge that the use of fitness trackers and remote assessment may not benefit all, an area which will be addressed in this work. Whilst many remote programmes do now exist, the use of fitness trackers to support these programmes has not been assessed.

Exercise intensity Many reported programmes use a measure called Rating of Perceived Exertion (RPE) to measure exercise intensity. RPE is a widely used and validated scale that has been shown to accurately correspond to intensity measured by maximum heart rate (HRmax) in many different populations.16-18 However, as a self-reported measure, it is inherently prone to measurement bias; a preliminary study found that over 60% of RPE measurements made by patients during prehabilitation were overestimates of the actual achieved intensity measured by achieved heart rate. It is therefore proposed that using fitness trackers individuals could exercise to prescribed heart rate zones to improve achievement of their exercise targets. A heart rate zone is a range of heart rates which corresponds to a desired training effect for an individual. They can be calculated as a percentage of the heart rate reserve (HRR) which is the maximum heartrate (HRmax) an individual can achieve minus their resting heartrate (RHR).

Existing prehabilitation programs prescribe the intensity of aerobic exercises to patients by asking them to exercise to a rating of perceived exertion (RPE). As a self-reported measure, there is an inherent propensity towards measurement bias, with studies reporting over 60% of RPE measurements made by patients during prehabilitation as overestimates of the actual intensity achieved when measured by their heart rate. Therefore, I hypothesise that prescribing to a heart rate zone and providing a heart rate tracker to monitor this will increase the levels of moderate intensity exercise achieved.

Self-reporting and Adherence

Direct links have been reported between the amount of physical activity completed each week and post operative outcomes (lower risk of post-operative pneumonia with increasing volumes of activity completed in the pre-operative period). 19 However, current programmes are reliant on self-reported adherence, making assessment of the true benefits challenging. A previous study of the PREPARE programme found an average adherence of 64% to the prescribed exercise.20 Adherence to home-based exercises is often lower than supervised programmes 21 and exercise participation during chemotherapy is particularly challenging.22 It is therefore important to explore ways to remotely support and encourage patients to follow their exercise programmes during prehabilitation. Fitness trackers provide a potential objective measurement of adherence to prescribed targets.

It is beneficial to provide home (vs. hospital) based exercise programmes. However, their effectiveness dependent on patients' adherence to the prescribed physical exercises (currently self-reported via an activity log), where activity is frequently over-reported. Heart rate trackers provide data on activity level and therefore can be used remotely to determine compliance.

Patient satisfaction of using fitness trackers

Whilst the theory of using fitness trackers in remote prehabilitation is attractive, it is only beneficial if the target population are engaged, willing and able to use the devices for the desired purposes. It is important to acknowledge that the demographics of those undertaking prehabilitation for OG, HPB and LC resections may not be representative of the average and could find the use of these technologies challenging.

There is no current evidence to demonstrate that patients find the use of wearable fitness trackers in prehabilitation acceptable. The benefits of using wearable fitness trackers in prehabilitation will be reduced if compliance with the device is low (i.e., they do not wear them). Therefore, there is a need to assess the acceptability, usability, and user experience of using heart rate trackers in a prehabilitation setting.

A prospective, two-arm randomised parallel group clinical trial. Prehabilitation is routinely offered as the standard of care to all patients who are scheduled for curative resectional surgeries for upper gastrointestinal (UGI) cancer at Imperial College Healthcare Trust and lung cancer at Guy's and St Thomas' NHS Foundation Trust.

Consecutive patients referred for prehabilitation will be approached for enrolment into the study. If willing to participate, written informed consent will be gained (e-consent). Following enrolment all participants will be provided with a wearable fitness tracker and will be randomised to one of two groups (1:1 randomisation) - Group A or Group B. The only difference between the two groups is the prescription of exercise, all other activities and data collected are the same.

Randomisation following recruitment and using a computer programme.

Because of the nature of the study and the interventions offered, it will not be possible to blind participants or research assistants to allocation groups.

Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers

The primary outcome will compare between intervention and control groups the total number of minutes of moderate intensity exercise, i.e., exercise within target range as measure on the Fitbit over the 8 weeks of follow-up

A comparison of the volume of physical activity (mean MET min/week) achieved between the intervention and control groups over the 8 weeks of follow-up.

A comparison of weekly adherence (mean percentage of actual/prescribed MET minutes/week) between the intervention and control groups over the 8 weeks of follow-up.

Comparison between participants self-reported duration of exercises (minutes) and their recorded duration of achieving \>40% of their heart rate reserve (minutes).

Comparison between participants self-reported intensity of exercises and their recorded heart rate intensity data (RPE vs % of target HR zone achieved) .

Descriptive analysis assessing the acceptability of the intervention to the participants using a validated questionnaire at the end of the intervention period.

TAM - 12 questions (6 on perceived usefulness. 6 on perceived Ease-of-use) each graded on a 7 point Likert scale

Descriptive analysis of a validated questionnaire assessing usability of the intervention to the participants taken at the end of the intervention.

UMUX-lite - 2 questions graded on a 7 point Likert scale

Descriptive analysis of the participants user experiences of the intervention using a validated questionnaire at the end of the intervention.

UEQ - 26 pairs of contrasting attributes that may apply to the product each to be graded on a 7 point Likert scale

Imperial College Healthcare NHS Trust

Guy's and St Thomas' NHS Foundation Trust

Imperial College London

Participants given an activity tracker at the given an accelerometer at each visit. Participants instructed in use of a smartphone application at the baseline visit.

Participant emailed electronic newsletters to read that may help participant be more physically active.

Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Participants sent electronic newsletters throughout the study that may help participant be more physically active.

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Group 1 - Intervention: Participants given an accelerometer at each visit. Participant wears the accelerometer for 7 days.

Group 2 - Newsletters: After completing the 16 week visit, participant given an activity tracker.

Activity Tracker

Group 1 - Intervention: Participant given smartphone application baseline visit to track physical activity, connect with participant's partner to share information about participant's physical activity, and provide support to partner to be more physically active.

Group 2 - Newsletters: After completing the 16 week visit, participant given instruction in the use of a smartphone application.

Smartphone Application

Participants complete questionnaires about feelings, moods, motivation for physical activity, any social support received from others, the neighborhood participant lives in, and other physical activity-related topics. Questionnaires completed 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.The questionnaires should take about 45 minutes to complete.

Questionnaires

Participants invited to take part in a final focus group. Focus group takes place sometime after the 16-week visit. Focus groups/interviews are audio recorded.

Focus Group

Participant emailed electronic newsletters to read that may help participant be more physically active.

Electronic Newsletters

Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Telephone Counseling

Larkin L. Strong, PHD

The goal of this research study is to learn if enrolling in a program with a partner that involves monitoring each other's physical activity and providing support to one another can help both participants be more physically active.

Study Groups:

If you are found to be eligible to take part in this study, you and your partner will be randomly assigned (as in a flip of a coin) to be in 1 of 2 groups after you complete the first in-person visit. You will have an equal chance of being in any group.

If you are assigned to Group 1, the following tests and procedures will be performed:

* You will wear an activity tracker that you will be given at the baseline visit. The activity tracker is a small device worn on your wrist that records how many steps you have taken.
* You will be instructed in the use of a smartphone application at the baseline visit which you will use to track your physical activity, connect with your partner to share information about your physical activity, and provide support to your partner to be more physically active.
* You will have 6 counseling calls over the telephone throughout the study with a trained counselor and your partner.
* You will be emailed electronic newsletters to read that may help you be more physically active.

If you are assigned to Group 2, you will be sent the newsletters that may help you be more physically active and upon completing the16 week visit, you will be given an activity tracker and instruction in the use of a smartphone application.

Study Visits:

You will visit MD Anderson Cancer Center, Windsor Village United Methodist Church, or a community site 2 times (1 time at the beginning of the study, and 1 time 16 weeks after you begin the study). Each visit should take about 90 minutes. The following procedures will be performed:

* Your blood pressure will be measured. If you have a blood pressure reading higher than 140/90 mm Hg, you can participate in this study only with a clearance letter from your physician or nurse practitioner. If your blood pressure reading is higher than 180/120 mm Hg, the study staff must contact 911 and have EMS come and treat you due to your blood pressure being dangerously high. You have the right to refuse EMS services but study staff are still required to contact 911 immediately as a precaution. You will not be able to continue in the study until the clearance letter has been received.
* You will complete questionnaires about your feelings, moods, your motivation for physical activity, any social support you may receive from others, the neighborhood you live in, and other physical activity-related topics. The questionnaires should take about 45 minutes to complete. For the 2nd visit, you will have the option of completing the questionnaire online before your scheduled visit. This may reduce the length of your 2nd visit.
* You will be asked about your diet (for example, what you eat and drink each day).
* Your height, weight, and waist and hip circumference will be measured. To measure your waist and hip circumference, you may be asked to lift your shirt to expose your stomach area and lower your pants to expose your mid-hip area. The height, weight, and waist and hip circumference measurements should take about 10 minutes and will be performed in a private area.
* Your heart rate variability (HRV) will be measured with a wrist watch and a belt band. To measure your HRV, you will be asked to lift your shirt to expose your upper stomach area (at the breast bone). The band will be damp and should make firm contact with your skin. °You will wear the device for 5 minutes while it records your HRV as you sit quietly.
* You will be given an accelerometer at each visit. You will wear the accelerometer for 7 days and then return it in an pre-addressed envelope provided to you. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.

At 8 weeks after you begin the study, you will answer some questions either over the phone or through an online survey. The questions will cover the same topics as for the in-person visits. This should take about 30 minutes to complete.

All participants will be invited to take part in a final focus group. This focus group will take place sometime after the 16-week visit. You will be asked what you think about the study, including what you liked, did not like, and how you think it could be improved. If you want to provide this feedback but you cannot come to the focus group, you may provide feedback in another way (such as a phone interview or you could meet the study staff at the church or a community setting). These focus groups/interviews will be audio recorded. Your name and identifying information will be deleted from the recording before being transcribed (typed out) by an outside party. This should take about 90 minutes. The digital audio files will be destroyed within 10 years after publication.

Length of Study:

Your participation on this study will be over after you complete the final focus group visit.

Additional Information:

If you are assigned to Group 1, you may be contacted by phone or mail while you are taking part in this study to remind you about study visits, study procedures, and counseling calls.

You will be asked to give the names and contact information of family members and/or friends for the study staff to contact in the event they cannot reach you first.

The counseling calls for Group 1 will be recorded to monitor counseling procedures.

You will also be asked to participate in two optional procedures. First, you will be asked to "friend" your counselor on the mobile application so that the counselor can monitor your steps in preparation for the counseling calls. Second, you will also be asked to share your user ID and password for the activity tracker. This will enable research staff to download your physical activity data that will help staff to understand how much participants are using the device and how many steps they are taking. These data will only be examined during the 16-week study period, and you will be instructed to change your password at the end of the study.

If the accelerometer is lost or stolen, you will not be responsible for the replacement cost, but you should tell the study staff right away.

You will be able to keep the activity tracker after the study is complete.

Your home address may be used to access public information about the area where you live. This is to help researchers learn about how your neighborhood encourages physical activity. The results from this study will only be reported as a group and you will not be identifiable from any products resulting from this study (such as research papers). Your home address will never be released or published in any form. Your address will be stored separately from other study data, and only the study chair will be able to see the data after the neighborhood information has been collected.

You may be contacted in the future to see if you would agree to take part in other research studies.

Women who are pregnant or thinking about becoming pregnant during the study period will no longer be able to participate. If you become pregnant during this study, please tell the study staff right away.

This is an investigational study.

Up to 64 participants will take part in this study. All will be enrolled at MD Anderson.

Using Social Networks to Promote Physical Activity in African American and Hispanic Women

Women's preferences for a physical activity (PA) promotion intervention determined by focus groups.

Study considered feasible only if recruitment and retention percentages reach the lower bound of the one-sided 90% confidence intervals of the target unless there are convincing arguments they can be improved sufficiently by modifying recruitment or retention strategies.

M.D. Anderson Cancer Center

Digestive System Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Esophageal Neoplasms

Pancreatic Neoplasms

Sarcoma

Head and Neck Neoplasms

Brain Neoplasms

Uterine Neoplasms

Carcinoma, Bronchogenic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Esophageal Diseases

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Esophageal Cancer

Pancreatic Cancer

Soft Tissue Sarcoma

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients phyiscal activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy.

Daniel Zips, MD, Prof.

Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.

This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in cancer patients on the Quality of life after oncological therapy. Quality of Life and the intensity of fatigue will be documented with the FACT-G total score of the FACIT Questionnaire six months after completion of radiotherapy.

Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy

Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)

This endpoint will be evaluated by the FACT-G (Functional Assessment of Cancer Therapy - General) total scores of the FACIT (Functional Assessment of Chronic Illness Therapy) questionnaire (physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well-being values 0-28, 28 better outcome

Women allocated to the intervention arm will used an activity tracker

Participants will receive a Withings Steel HR activity tracker (Withings, Issy-les-Moulineaux, France), which they will be asked to wear 24 hours per day throughout the whole intervention (12 months). At baseline, the Withings Health Mate mobile phone application will be downloaded onto each participant's smartphone or tablet. The clinical research assistant will instruct the participant in the use of the activity tracker. The participant will then accept and activate the sharing of the data collected with the secure server dedicated to the "NeoFit" study at the Institut Curie. Participants will be asked to synchronize the activity tracker regularly (ideally daily) via Bluetooth with the Withings Health Mate application, for automatic transfer of the data to the secure "NeoFit" space.

Activity tracker

Fabien Reyal, MD

Jean-Guillaume Feron, MD

Fabien REYAL, MD

Fabien REYNAL, MD

Florence LEREBOURS, MD

NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC. Participants will receive a Withing Steel HR activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. The investigators will evaluate clinical (e.g. toxicity, efficacy of chemotherapy), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

BACKGROUND: In young women, breast cancer (BC) has particular characteristics, such as a more advanced stage at diagnosis, aggressive tumor characteristics, and a poorer prognosis. NeoFit aims to use an activity tracker to identify and describe various digital profiles (physical activity, heart rate, sleep) in women under 70 years of age treated with neoadjuvant chemotherapy for BC.

METHODS: NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC. Participants will receive a Withing Steel HR activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. The investigators will evaluate clinical (e.g. toxicity, efficacy of chemotherapy), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

DISCUSSION: NeoFit will make it possible, through the use of an activity tracker, to visualize changes, over a one-year period, in the lifestyle of young women treated for BC by neoadjuvant chemotherapy. This exploratory study will provide fundamental knowledge about the digital phenotypes of young BC patients treated with NAC and their relationships to chemotherapy toxicity and efficacy. This trial will pave the way for interventional studies on physical activity and sleep interventions.

Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy

Digital Phenotyping (Physical Activity, Heart Rate, Sleep) in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

The activity tracker will register step counts for each day. the investigators will plot the average daily step counts and the 95% confidence interval across the entire study period. Then will will study the change in step count trajectory during the study. Linear mixed model will be used for describing change over time

The activity tracker will register heart rate at 10-minute intervals for each day. The investigators will plot the average heart rate frequency and the 95% confidence interval across the entire study period. Then will will study the change in heart rate frequency trajectory during the study. Linear mixed model will be used for describing change over time

The activity tracker will register sleep duration for each day. The investigators will plot the average sleep duration and the 95% confidence interval across the entire study period. Then will tudy the change in sleep duration trajectory during the study. Linear mixed model will be used for describing change over time

To identify digital profiles, The investigators will combine step counts profiles, heart frequency profiles and sleep profiles using mixed models with latent classes. The use of a mixed model will make it possible to analyze repeat data for the population, and to determine an average profile or trajectory for the whole population. The optimal number of classes will be determined a posteriori, based on a set of statistical and clinical criteria. The most widely used statistical criterion is the "Bayesian information criterion" (BIC), which penalizes the model's likelihood according to its complexity. The BIC, which is stricter than many other criteria, has been shown to have a better performance in simulations. The number of trajectories will also be based on clinical interpretation (whether it is worthwhile retaining classes containing very small numbers of subjects, etc.).

Occurence of severe toxicity (grade \>2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Tests will be performed to compare means (Student's t test), or categorical variables (chi2test). The investigators will also perform multinomial logistic regression analyses with univariate and multivariate models, to determine the probability of belonging to a class relative to the corresponding reference class

Quality of life will be assessed with the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) Quality of Life Questionnaire (EORTC QLQ-C30) version 3 validated in 2000, a multidimensional questionnaire validated for use with cancer patients. The QLQC30 questionnaire contains 30 items assessing five functional domains (physical, role, emotional, cognitive, and social), one overall quality-of-life domain, three symptom domains (pain, fatigue and nausea), and six individual items (dyspnea, insomnia, anorexia, diarrhea, constipation, and financial impact). Participants will respond on a Likert scale ranging from "not at all" to "very much" and from "very poor" to "excellent" for the overall quality-of-life questions only. Scores will be standardized on a scale of 0 to 100, according to the EORTC scoring manual. Higher scores correspond to better functioning, a better overall quality of life and more symptoms.

The multidimensional aspects of fatigue will be evaluated with the EORTC QLQ-FA12 version 1 module, which was validated for cancer-related fatigue in 2017. EORTC QLQ-FA12 contains 12 items assessing the physical, cognitive, and emotional domains of cancer-related fatigue. Participants will complete a four-point Likert-scale questionnaire, with responses ranging from "not at all" to "very much". All scores will be transformed to a scale of 0 to 100, with higher scores indicating a greater degree of fatigue. The estimated completion time for this questionnaire is five minutes.

Tests will be performed to compare means (Student's t test), or categorical variables (chi2test). The investigators will also perform multinomial logistic regression analyses with univariate and multivariate models, to determine the probability of belonging to a class relative to the corresponding reference class

The prediction of treatment toxicity will be assessed by CTCAE v4.0.

The prediction of fatigue will be assessed by change from baseline in fatigue scores on FA12 questionnaire and at the end of the neoadjuvant chemotherapy and at 12 months..

The prediction of a deterioration of the quality of life will be assessed by change in the global score in EORTC QLQC30 questionnaire from baseline and at the end of the neoadjuvant chemotherapy and at 12 months..

Institut Curie

Aromatase Inhibitors

Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy

Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy

Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks

Activity program

Control

Friedemann Honecker, MD

Nicolette Hoefnagels, MSc

The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant aromatase inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.

After tumor removal, patients with hormone receptor positive breast cancer tumors often receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being standard of care in the population of postmenopausal women. Common side effects of AI therapy are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia and/or myalgia can result in lower physical activity and can negatively influence quality of life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered for 5 and sometimes even 10 years, this is a major clinical challenge.

For breast cancer patients undergoing AI therapy, physical activity can provide potential benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive effect of physical activity on AI side effects, however, remains elusive. In addition, activity programs to reduce AI side effects have so far mostly been rather complex. The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.

Furthermore, this trial will assess the effect of physical activity on symptom burden in general and quality of life in patients receiving adjuvant AI therapy. During the follow-up phase, the trial will assess whether this intervention leads to a sustained change in lifestyle regarding activity, less pain, and better treatment adherence in the intervention group.

1. Home-based walking intervention for 24 weeks + standard adjuvant AI therapy
2. Physical activity according to standard recommendations for 24 weeks + standard adjuvant AI therapy

Activity Program During Aromatase Inhibitor Therapy

A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial

Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire.

The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its "worst", "least", "average" in the last 24 hours and "now" (current pain), each item being rated on a 0-10 scale.

Fatigue will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Physical scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Role scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Emotional scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Nausea/vomiting will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Pain will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Global health status will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Dyspnoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Insomnia will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Appetite loss will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Constipation will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Diarrhoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Financial difficulties will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Hot flashes will be assessed at baseline, during intervention phase and during follow-up phase via the item 37 of the EORTC QLQ BR-23.

Severity of muscle or joint pain/stiffness will be measured by the four BPI pain severity items. Pain interference will be calculated as the mean of the seven interference items.

During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.

Adherence will be assessed by patient self-report (diary).

Adherence will be assessed by patient self-report (questionnaire completed at visits).

Swiss Group for Clinical Cancer Research

Behaviors and Mental Disorders

Quality of Life

Patients with brain tumor(s) will be give a wireless activity tracker (fitbit flex) to use during treatment. They will complete quality of life surveys and a sleep survey.

Wireless Activity tracker: Fitbit

David Darrow, MD MPH

This project attempts to correlate wireless activity data with quality of life and sleep surveys in order to find a new method of monitoring patients during their treatment.

This project proposes the investigation, validation, and use of a wireless activity tracker to better understand and improve the quality of life of patients suffering from brain tumors. The Fitbit flex wireless syncing activity tracker will be distributed to 75 patients, and the electronic infrastructure to automatically track patients will be created and adapted for the cohort. Surveys will routinely assess the ease-of-use and any problems arising. This heterogenous population of patients suffering from brain tumors will be tracked and compared through routine evaluation of their quality of life through well-established surveys, including the SF-36 and FACT-Br. The association between data recorded from the activity tracker and the QOL surveys will be quantified to validate the activity tracking data as a surrogate measure of part, if not all, of QOL as well as sleep.

Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase

Individual data will not be shared. De-identified group data will be made available

wireless activity will attempt to monitor sleep cycles when the device is worn

University of Minnesota

Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.

Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations whilst they are undergoing chemotherapy. Participants will also complete questionnaires related to health inequalities and quality of life.

Participants will wear continuous glucose monitors for a 7 day period.

Continuous glucose monitors

Participants will wear the activity tracker for a 7 day period.

Participants will complete a food diary of everything they eat for 7 days.

Food Diary

Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer	NCT04506476	Breast Cancer	Fitness tracker...	18 Years -	University Hospital Tuebingen
Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers	NCT06071650	Cancer	Exercise to a H...	18 Years - 80 Years	Imperial College London
Using Social Networks to Promote Physical Activity in African American and Hispanic Women	NCT03199196	Cancer Preventi...	Activity Tracke... Smartphone Appl... Questionnaires Focus Group Electronic News... Telephone Couns...	25 Years - 60 Years	M.D. Anderson Cancer Center
Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy	NCT04517019	Bronchial Carci... Esophageal Carc... Tumor of the Br... Head and Neck C... Pancreas Cancer Sarcoma Cervix Uteri Ca...	Fitness tracker...	18 Years -	University Hospital Tuebingen
Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy	NCT05011721	Breast Cancer	Activity tracke...	18 Years - 70 Years	Institut Curie
Activity Program During Aromatase Inhibitor Therapy	NCT03786198	Early Breast Ca...	Activity progra... Control	18 Years -	Swiss Group for Clinical Cancer Research
Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase	NCT02674945	Brain Tumor	Wireless Activi...	18 Years - 99 Years	University of Minnesota
A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.	NCT05583890	Pancreatic Canc...	Continuous gluc... Activity tracke... Food Diary Questionnaires	18 Years - 85 Years	Lancaster University
Activity Program During Aromatase Inhibitor Therapy	NCT03786198	Early Breast Ca...	Activity progra... Control	18 Years -	Swiss Group for Clinical Cancer Research
Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers	NCT06071650	Cancer	Exercise to a H...	18 Years - 80 Years	Imperial College London
A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.	NCT05583890	Pancreatic Canc...	Continuous gluc... Activity tracke... Food Diary Questionnaires	18 Years - 85 Years	Lancaster University

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