Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Body Weight

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients planned for pancreatic resection will be included for a home-based prehabilitation program.

The home-based prehabilitation program will consist of a four-week program, where patients are expected to perform a high-intensity interval training on a home-trainer combined with functional mobility training three times a week. The program is partly supervised by a trained physiotherapist.

Home-based prehabilitation program

Nicole Hildebrand, M.D.

Allard Wijma, M.D.

Paola Costelli, PhD

Steven Olde Damink, M.D., M.Sc., PhD

Rationale: The complication rate after pancreatic resection is high, especially in elderly and physically unfit patients. Aerobic capacity, as indicated by the ventilatory anaerobic threshold (VAT) assessed by a cardiopulmonary exercise test (CPET), can be used to identify high-risk patients. Previous studies have demonstrated that exercise prehabilitation can increase aerobic capacity in patients scheduled for intra-abdominal surgery, subsequently leading to better treatment outcomes. There is limited evidence on the feasibility of a (partly) supervised home-based prehabilitation program in patients scheduled for pancreatic resection.

Objective: The primary objective of this study is to assess the feasibility of a four-week supervised home-based prehabilitation program in patients scheduled for elective pancreatic resection. Secondary objectives are to evaluate individual responses to prehabilitation on a number of secondary endpoints (no cause-effect relationship to be established).

Study design: This study is a pragmatic multicenter study with a pretest-posttest design. It will take place at the Maastricht University Medical Center+ and University Medical Center Groningen in the Netherlands, and at the 'Città della Salute e della Scienza' in Torino, Italy.

Study population: Patients planned for elective resection of a pancreatic tumor will be screened for potential eligibility. High-risk patients, identified by an oxygen uptake (VO2) at VAT ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min, will be asked to participate.

Intervention: A total of 45 patients will participate in a four-week (partly) supervised home-based personalized exercise training program before surgery (12 sessions in total). An advanced cycle ergometer (Lode Corival, Lode BV, Groningen, the Netherlands) will be delivered at the patient's home. Three weekly sessions of high-intensity interval training on the cycle will be combined with functional task exercise training. A trained physical therapist will visit the patient at least weekly to monitor progress.

Main study parameters: The main study parameter is feasibility of the (partly) supervised home-based prehabilitation program. Hereto participation rate and reasons for non-participation will be evaluated. In participating patients, adherence/compliance, dropout rate, reasons for dropout, adverse events, patient motivation, and patient and therapist appreciation will be assessed throughout the program.

Secondary endpoints: Secondary endpoints before and after prehabilitation include aerobic capacity, muscle function, body composition, functional mobility, immune system function, perceived fatigue, quality of life, and sarcopenia. Data on patient characteristics, neoadjuvant therapy, surgical procedure, and postoperative outcomes will also be collected for explorative purposes.

As the aging population grows, the incidence of malignancies of the pancreas will also rise. Surgery is an important treatment modality; at the same time, it is a challenge (allostatic load) for the patient's homeostasis. Age- and disease-related psychophysiological changes and comorbidities affect tolerance to surgery (adaptive capacity). Prehabilitation may increase a patient's ability to cope with surgical-induced allostatic load by improving the capacity and functioning of the respiratory, cardiovascular, and/or musculoskeletal systems, and therefore lower the risk of postoperative morbidity and mortality.

About 28% of patients undergoing pancreatic resection developed a major complication (Clavien-Dindo grade III or higher), and 3.2% deceased in-hospital in the Netherlands between 2014 and 2017. Older patients, especially physically unfit patients, are more prone to complications.

Preoperative aerobic capacity has been found to have a consistent relationship with postoperative outcome in major elective intra-abdominal surgery, such as pancreatic resection. Previous studies consistently indicated that an oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) \<11mL/kg/min and/or a VO2 at peak exercise (VO2peak) \<18mL/kg/min, as determined during a cardiopulmonary exercise test (CPET), are cut-off points to identify patients that have a higher risk for postoperative morbidity and mortality. Exercise prehabilitation has been reported to be able to preoperatively increase the physical fitness of patients scheduled for elective intra-abdominal surgery, of which high-risk patients will benefit the most. Most prehabilitation programs were carried out under supervision in an outpatient clinic. Often however, patients are not able or willing to participate, for example because of travelling issues or because it is becoming 'too much'. Home-based programs are often unsupervised and lack the ability to monitor adherence of the patient, and therefore might lack effectiveness.

A personalized exercise program in a home-based setting might enhance the participation rate, motivation, and adherence of patients. This has proven to be the preferred method for previous prehabilitation programs. Although several studies investigated the effects of exercise prehabilitation before pancreatic resection and reported positive effects on preoperative physical fitness and postoperative morbidity, there is limited evidence addressing the feasibility and effectiveness of (partly) supervised home-based prehabilitation in these populations. Moreover, effectiveness has not been evaluated using sophisticated outcome measures.

In a recent study in patients planned for liver or pancreatic surgery the adherence rate of a semi-supervised home-based training program was 83%. Furthermore, it led to an increase in VO2 at the VAT of 17.8% and VO2peak of 17.2%. This leads to the hypothesis that a partly supervised home-based prehabilitation program is feasible in a high risk-group. To test this hypothesis further the study will investigate the feasibility of a (partly) supervised prehabilitation program and will focus on patients undergoing pancreatic resection.

Objectives:

The primary objective of the study is to assess feasibility of a four-week (partly) supervised home-based prehabilitation program in patients scheduled for elective pancreatic resection. This will be measured using participation rate, reasons for non-participation, adherence/compliance, dropout rate, reasons for dropout, adverse events, patient motivation, and patient and therapist appreciation.

Secondary objectives are to evaluate individual responses to prehabilitation on the secondary study parameters. Data on patient characteristics, neoadjuvant therapy, surgical procedure, and postoperative outcomes will also be collected for explorative purposes.

Study design:

This study is a pragmatic multicenter study with a pretest-posttest design. It will take place at the Maastricht University Medical Center+ and University Medical Center Groningen in the Netherlands, as well as at the 'Città della Salute e della Scienza' in Torino, Italy.

Patients planned for elective pancreatic resection will be screened for CPET by a trained oncology nurse specialist. A trained medical physiologist will perform the CPET. Patients are eligible for the study if they have an oxygen uptake (VO2) at the VAT of ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min. Potential candidates will be given full details of the study and invited to participate. If patients give permission, they will be contacted by an investigator who provides extensive information about the study.

If patients sign informed consent, they will fill out the baseline questionnaires (perceived fatigue, quality of life, and sarcopenia), and undergo baseline testing. Baseline tests include body composition, functional mobility, questionnaires, and immune system function.

After baseline assessment an advanced cycle ergometer (Lode Corival Home+, Lode BV, Groningen, the Netherlands) will be delivered to the patient's home. A trained community physical therapist will visit the patient at home to explain correct use of the ergometer and to (partly) supervise training program. A steep ramp test will be carried out by the physical therapist. The high-intensity interval exercise training program on the cycle ergometer will be personalized based on a weekly supervised steep ramp test. Every training session on the ergometer will take 30 minutes. Next to training at the cycle ergometer, patients will complete 15 minutes of functional exercises (e.g., sit-to-stand exercises, stair-climbing, cycling, walking). The patient will be asked to perform different types of exercises, a total of 15 exercises of about 30 seconds, with 30 seconds of rest in between. The physical therapist will explain the functional exercises and supervise the patient in the first week. Based on the patient's progress in muscle function and functional mobility, which will be tested weekly using the 30-second chair stand test at the patient's home, the physical therapist will adjust the exercises weekly. Patients will be asked to train three times a week for four weeks. In the first week, the physical therapist visits three times, whereas the patient will be visited once a week in week 2, 3, and 4.

After the prehabilitation program, patient and therapist will fill out an appreciation questionnaire. The other questionnaires will be filled in again. Also, tests on aerobic capacity, body composition, functional mobility, and immune system function will be repeated.

Aerobic capacity A maximal CPET will be performed using a calibrated electronically braked cycle. Patients with contraindications for CPET due to cardiorespiratory comorbidities will not be able to participate in the study. The patient will be fitted with an electrocardiogram, as well as a calibrated respiratory gas analysis system, that will calculate breath-by-breath VO2, carbon dioxide production (VCO2), and minute ventilation. Blood pressure and peripheral oxygen saturation will be monitored. After two minutes of rest measurements, the patient starts cycling unloaded for 2 minutes. Thereafter, depending on the patient's physical fitness, the work rate will be linearly incremented with a 5, 10, 15, or 20W/min ramp protocol to ensure a test duration between eight and twelve minutes. Patients will be instructed to maintain a pedaling frequency of 80/min. Test effort will be considered maximal when the patient shows objective (heart rate at peak exercise \>95% of predicted and/or a respiratory exchange ratio at peak exercise \>1.10) and subjective (unsteady biking, sweating, facial flushing, inability to continue despite encouragement) signs of maximal effort. Perceived exertion before and directly after CPET, using a ten-point visual analog scale, will be asked. CPET interpretation will be performed by a trained and experienced medical physiologist. The ventilatory anaerobic threshold is defined as the point at which the ventilatory equivalent for oxygen and the partial end-tidal oxygen tension reached a minimum and thereafter began to rise in a consistent manner, coinciding with an unchanged ventilatory equivalent for carbon dioxide and partial end-tidal carbon dioxide tension. If this method appeared to provide uncertain results, the V-slope method will be used.

A steep ramp test will be performed on a weekly base at the patient's home under supervision of a physical therapist to assess and monitor aerobic fitness. The advanced cycle ergometer will be used for the steep ramp test. The patient will be fitted a heart rate belt around the chest (Polar Elektro Oy, Kempele, Finland) during the test. After three minutes of rest the test will start and the work rate will be increased by a constant increment of 10 W every 10 seconds in a ramp like manner. Test duration will be four to seven minutes. The pedaling frequency should be kept constant between 60 and 80 revolutions per minute. Peak exercise is the point at which there is a sustained drop in pedaling frequency from 60 revolutions per minute, despite verbal encouragement. Data will be stored for further use. A ten-point VAS will be used to ask the level of perceived exertion. The attained peak work rate (WRpeak) will be used to adjust the training protocol for the upcoming week.

Muscle function Muscle function measurement will be measured for patients in Città della Salute e della Scienza. Knee extensors torque will be recorded using an isokinetic device under isometric sub-maximal and maximal voluntary contractions. The rate of torque development will be calculated for each contraction at different submaximal amplitudes (from 20% to 80% of maximal voluntary torque). Lastly, to measure muscle fatigability, participants will perform a submaximal isometric contraction at 70% of maximal voluntary torque until task failure (the time failure typically occurs within 60 s). High-density surface electromyographic (HDEMG) signals will be recorded from the vastus lateralis and medialis muscle during all muscle contractions to record muscle fiber conduction velocity. Muscle fiber conduction velocity is an important physiological variable associated to the qualities of skeletal muscles. Furthermore, HDEMG signals will be decomposed to identify and assess the activity of a large number of motor units over a wide range of torques, providing direct evidence on the strategies used by the central nervous system to control muscle torque.

Body composition The patient's body mass and body height will be measured pre-, and post-intervention. Body mass will be measured weekly at the patient's home. To assess skeletal muscle mass and quality a single slice of the patient's abdominal CT-scan will be selected at the level of the third lumbar vertebra (L3). Scans will be analyzed using an automated segmentation system developed and validated at Maastricht University. Skeletal muscle, visceral adipose tissue, and subcutaneous adipose tissue areas will be normalized for the patient's body height to calculate the L3 index in cm2/m2. Skeletal muscle radiation attenuation will be assessed by calculating the average Hounsfield Units value of skeletal muscle mass.

Functional mobility Functional mobility will be assessed in all patients using the 30-second chair-stand test pre- and post-intervention at the hospital, and weekly at the patient's home. Additionally, a 2-minute walk test will be performed pre- and post-intervention. The 30-second chair-stand test evaluates a combination of functional mobility, balance, and lower leg muscle strength. The primary outcome is the repetitions of standing up from a sitting position and sitting back down with crossed arms within 30 seconds. The 2-minute walk test records the distance in meters that is walked within two minutes, with a walking aid if necessary.

Immunological phenotyping Given the evidence that exercise leads to changes in the innate and adaptive immune system, blood samples will be drawn pre- and post-intervention. Levels of interleukin 6, interleukin 8, and interleukin 10, as well as C-reactive protein, and tumor necrosis factor-α will be measured by multiplex analysis. Blood samples will be centrifuged, and plasma will be stored in aliquots at -80 °C until assayed for future analysis. Blood samples will be stored, for a maximum of ten years, in the biobank of the participating hospital. Future analysis must be in line with the aims of our current research; if not, informed consent must be obtained.

Questionnaires Patients will fill out the multidimensional fatigue index, a self-reporting questionnaire with 20 propositions about different dimensions and consequences of fatigue. A higher score means a higher level of perceived fatigue. Patients will also fill out the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30), a questionnaire with 30 items in four domains developed to assess the quality of life in cancer patients. A difference to baseline of 10 points can be considered clinically relevant. The SARC-F, a five-item questionnaire on the consequences of sarcopenia will also be filled out by the patients.

Preoperative patient characteristics:

Relevant demographic data (e.g., age and sex of participants), diagnosis, American Society of Anesthesiologists score, and Charlson comorbidity index will be collected preoperatively.

Postoperative care Details on type of surgery and intraoperative outcomes will also be collected. According to standard of care, all patients will receive postoperative physical therapy after surgery in all three participating centers. Postoperative complications will be recorded for 30 days and scored according to the Clavien-Dindo classification. The 30-day readmission rate will also be recorded. Surgical outcomes will be obtained from the electronic patient record system and from patient's physical examination on the ward.

Home-based Prehabilitation in Pancreatic Resection

Feasibility of Supervised Home-based Exercise Prehabilitation in Patients Scheduled for Pancreatic Resection

Rate of eligible patients that participate in the prehabilitation program

Patient's reasons for non-participation in the prehabilitation program while being eligible

Adherence rate to the prehabilitation program

Dropout rate of the prehabilitation program

Participant's reasons for dropping out the prehabilitation program

Any undesirable experience occurring to a participant during the study, whether or not considered related to the experimental supervised home-based prehabilitation program

Patient appreciation measured via an appreciation questionnaire

Therapist appreciation measured via an appreciation questionnaire

Oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) and VO2peak

Knee extensors torque in an isokinetic device under isometric submaximal and maximal voluntary contractions

Automated segmentation of body composition on L3 level of abdominal CT-scans

European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)

University Medical Center Groningen

University of Turin, Italy

Nicole Hildebrand

PhD-candidate HPB-Surgery

Nutritional and Metabolic Diseases

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Sander Rensen, PhD

Misha Sier, M.D.

Steven Olde Damink, PhD, MSc., M.D.

Rationale: One of the greatest challenges in the field of cancer treatment is cachexia, a multifactorial syndrome characterized by substantial loss of body weight (muscle and fat mass), leading to progressive functional impairment. Cancer cachexia significantly impairs quality of life and survival as well as treatment outcome. Despite its considerable relevance for the prognosis of cancer patients, the diagnosis of cachexia is problematic. The current consensus definition of cancer cachexia is based on weight loss over the last six months. In practice, this is assessed by subjective reporting by the patient, which is subject to error and bias. Novel technologies enable accurate, standardized, and objective assessment of body weight and physical activity by newly diagnosed cancer patients in the home situation. Because of the increasing implementation of neo-adjuvant treatment strategies that offer an extended time-window for the collection of these data, there is a great opportunity to use this information in risk analyses by treating physicians, optimization of pre-habilitation programs, and in the shared-decision making process with the patient.

Objective: The primary objective of this study is to obtain accurate data regarding physical activity, body composition, and body weight loss over time in patients with gastric, esophageal, rectal, pancreatic, or ovarian cancer in relation to treatment outcome, adverse events (chemotoxicity and/or surgical complications), and survival.

Study design: Explorative pilot study

Study population: Patients between 18 and 80 years old undergoing surgical resection or neo-adjuvant chemotherapy for the treatment of gastric, esophageal, rectal, ovarian, or pancreatic cancer.

Main study parameters/endpoints: Objective data acquisition on activity (three axis acceleromotion using a wrist-worn accelerometer), body weight (at home measurement with memory integrated weight scale), and body composition in relation to treatment outcome, evaluated using RECIST, adverse events, assessed via chemotoxicity and surgical complications using the Clavien-Dindo classification, and length of hospital stay in gastric, esophageal, rectal, pancreatic, and ovarian cancer patients.

Secondary endpoints: To assess body weight changes and physical activity in relation to survival.

Patients requiring neo-adjuvant chemotherapy or primary surgery for pancreatic, esophageal, gastric, ovarian, or colorectal cancer will be included. Patients will undergo extensive pre-treatment screening, and then receive a weight scale for daily at-home measurements of body weight and an accelerometer for assessing physical activity. Body weight data will be collected using an electronic weight scale with integrated memory SD cards for automated autonomous storage of data (CE licensed). Physical activity will be monitored through a research grade wrist-worn accelerometer that records movement in three axes as well as body position (sedentary versus standing position). Data on frequency, intensity, and duration of activity will be collected. Activity can be summarized into light, moderate and (very) vigorous activity. Additionally, data on sedentary behavior will be collected.

Monitoring plan for patients treated with chemotherapy:

T0 Start of monitoring: When patients first present at the outpatient clinic, they will receive extensive physical analysis by a trained physiotherapist. The screening will consist of the following: Timed Up and Go test, Chair stand test, 2-minute walking test, hand grip strength test, steep ramp test, and short nutritional assessment procedure. This screening is already part of clinical routine and pre-operative screening for extensive abdominal surgery at the MUMC+. Additionally, the investigators will collect one blood sample. Patients will receive equipment (weight scale and accelerometer) for at home monitoring. The patient will start using the weight scale daily and wear the accelerometer continuously after screening.

T1: Start of chemotherapy: During chemotherapy, the body weight and physical activity measurements will continue. Patients will use the scale once daily and the accelerometer continuously. Chemotherapy related outcomes will be recorded during routine patient contacts, including treatment toxicity, intensity, and outcome as monitored according to the Common Toxicity Criteria version 5.0 and by assessing dose index (received cumulative dose/planned cumulative dose) and time index (planned duration of therapy/actual duration of therapy). Treatment outcome will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST).

T2: End of chemotherapy: The monitoring will continue until two weeks after chemotherapy.

T3: End of monitoring (at routine follow-up by senior surgeon, usually 2-3 weeks after completion of chemotherapy). A routine CT-scan to assess the effect of the chemotherapy will be performed. Body composition analysis at the L3-level will be used to assess the cross-sectional area and radiation attenuation of skeletal muscle (SM), subcutaneous adipose tissue (SAT), visceral adipose tissue (VAT), and intramuscular adipose tissue. This will be done using automated segmentation. Patients will hand in all equipment to the researcher during regular follow-up.

Monitoring plan for patients treated with surgery:

T0 start of monitoring: When patients first present at the outpatient clinic, they will receive extensive physical analysis by a trained physiotherapist. The screening will consist of the following: Timed Up and Go test, Chair stand test, 2-minute walking test, hand grip strength analysis, steep ramp test, and short nutritional assessment procedure. This screening is already part of clinical routine and pre-operative screening for extensive abdominal surgery at the MUMC+. Additionally, the investigators will collect one blood sample. Patients will receive equipment (weight scale and accelerometer) for at home monitoring. The patient will start using the weight scale daily and wear the accelerometer continuously.

T1: Hospital admission:

At the day of admission, the patient will not bring the weight scale and accelerometer to the hospital. Monitoring will be paused for the length of hospital stay for primary surgery. Postoperative complications will be recorded according to the Clavien-Dindo classification.

T2: Discharge from hospital:

At the day of discharge after primary surgery, length of stay at the hospital will be recorded. The patient will be reminded to restart monitoring and use the weight scale daily and wear the accelerometer continuously.

T3: End of monitoring:

During the regular follow-up visit 2-3 weeks after discharge, monitoring will end. Patients will hand in all equipment to the researcher during the regular follow-up visit. Over the course of the oncological follow-up, a routine CT-scan will be performed. Body composition analysis at the L3-level will be used to assess the cross-sectional area and radiation attenuation of skeletal muscle (SM), subcutaneous adipose tissue (SAT), visceral adipose tissue (VAT), and intramuscular adipose tissue. This will be done using automated segmentation.

The investigators will obtain blood samples twice during this period at T0 and just prior to incision on the day of surgery (T1) to analyse HbA1c, haemoglobin, CRP, TNF-α, interleukin-6, blood lipids, and additional parameters related to inflammation. No diagnostic procedures or treatment will be postponed.

Blood samples will be freezed at -80°C and will be stored for 15 years and analyzed if new insights related to this research should arise.

Patient Recorded Indexing Measurements

At home measurement with memory integrated weight scale

Treatment outcome will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST)

Automated segmentation of body composition on the L3 level of abdominal CT-scans

Chemotoxicity according to Common Toxicity Criteria v5.0

Postoperative complications rated according to Clavien-Dindo classification

Zuyderland Medisch Centrum

Maastricht University

Academisch Ziekenhuis Maastricht

Coordinating Investigator

Individuals will eat between 12-8pm ad libitum, fasting from 8-12pm.

Individuals will eat between 12-8pm ad libitum, fasting from 8-12pn with the addition of a prebiotic fiber supplement with the first eating bout of the day.

Time restircted eating

Time restricted eating + prebiotic

Kelsey Gabel, PhD

This study aims to address a critical gap in pediatric oncology survivorship care by exploring innovative solutions to addressing obesity and its comorbidities in pediatric cancer survivors. The majority (99%) of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition. Obesity, cardiovascular, and metabolic diseases are the most common treatment-related late effects among pediatric cancer survivors. Improving diet and reducing obesity has the potential to dramatically improve the quality of life and long-term health of pediatric cancer survivors. Utilization of a prebiotic fiber supplement along with TRE amy improve the gut microbiome, short-chain fatty acid synthesis, and hunger hormones to further improve weight loss with TRE and a greater decrease in cardiometabolic risk. The aims of this study are to test the safety, feasibility, and acceptability of 8-h TRE or 8-h TRE with a fiber supplement among young adult (YA) pediatric cancer survivors. The investigators further strive to examine the preliminary efficacy of TRE on body weight, body composition, glucose regulation, and cardiovascular risk markers. Data obtained will be used to inform a larger efficacy trial of TRE among adolescent and young adult pediatric cancer survivors. Given that a majority of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition exploring accessible nutritional strategies to improve long term health trajectory of 70,000+ AYA diagnosed with cancer each year in the United States. This study of TRE will provide important preliminary evidence of the benefits of this nutrition therapy for YA pediatric cancer survivors. The long-term goal of this line of inquiry is to improve both short and long-term outcomes for YA pediatric cancer survivors.

Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors

Clinicians will refer ≥ 75% of AYA pediatric cancer survivors that are eligible, we will screen and enroll ≥ 50% of those referred, participants will complete ≥ 80% of planned study visits, and we will retain ≥ 80% of participants in both study arms through the end of the intervention.

TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).

Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm

Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL).

fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.

systolic and diastolic blood pressure with cuff

Heart rate measured by blood pressure cuff

University of Illinois at Chicago

Clinial Assistant Professor and Postdoctoral Researcher

Behaviors and Mental Disorders

Blood and Lymph Conditions

Depression

Depressive Disorder

Hematologic Diseases

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

5-week CBT-based mobile intervention for adolescents with depressive symptoms

5-week mobile control with education about depression

SparkRx is a 5-week program divided into levels intended to be completed weekly. SparkRx is a behavioral activation program. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and participant symptom check (PSC) in the mobile app. Tasks in the mobile app progress in a linear fashion (i.e., each task must be completed to progress to the next task).

CBT-based mobile intervention for depression

The control mobile application will consist of 5 weeks of educational content about depression. Participants will be instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and PSC in the mobile app.

Mobile control with education about depression

Julie Germann, PhD.

The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).

The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).

These aims will be accomplished by evaluating:

* Feasibility of recruiting and enrolling adolescents with mild to severe symptoms of depression from specialty care medical programs at CHST.
* Retention, program adherence, completion, and withdrawal rates.
* Perceived utility, usability, and enjoyment of the program by adolescents
* Clinically significant changes between pre- to -post treatment and persistence of such gains at 1 month follow up.
* Preliminary evidence of efficacy defined as a statistically significant difference in the eight-item Patient Health Questionnaire (PHQ-8) scores (p \< 0.05) between Spark and an educational control at post-treatment.
* Safety of the intervention, including rates of reported adverse events and adverse device effects

Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management

Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management

Difference in the change in PHQ-8 scores between the SparkRx and control arms. Score range of 0 to 24 with higher scores indicating worse outcome.

Measured by the Generalized Anxiety Disorder scale (GAD-7).The GAD-7 is a brief 7-item assessment for generalized anxiety disorder with satisfactory sensitivity and specificity. Score range of 0 to 21 with a higher score indicating worse outcome.

Measured using the Short Form-36 (SF-36), a set of generic, coherent, self-reported, and easily administered quality-of-life measures used to routinely monitor and assess the care outcomes of participants. 8 subscales with scores ranging from 0-100, higher being a more favorable health state.

Physical functioning Role limitations due to physical health Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health

Measured using caregiver proxy measures of the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Measured using caregiver proxy measures of the SF-36. 8 subscales with scores ranging from 0-100, higher being a more favorable health state.

Measured using the Hope Scale, a 12-item self-report measure, which assesses dispositional hope in adults. Each item rated from 1-8 (definitely false - definitely true). Scores range from 8-64, with higher being more hopeful.

Subscales: agency and pathway.

Descriptive understanding of healthcare utilization. Measured by the Healthcare Utilization Questionnaire. A two-item questionnaire that assesses participants' use of healthcare resources.

Descriptive understanding of caregiver burden, measured by the work absenteeism questionnaire, containing questions about caregiving responsibilities and related impacts on employment. Higher scores indicate more hours missed per week of work.

Measured by the Functional Disability Inventory a fifteen-item questionnaire that measures functional disability and evaluates the impact of illness on the respondents' physical and psychosocial functioning in everyday social roles. Each question is rated on a 5-point scale from 0(No Trouble) to 4 (Impossible). Score range is 0 to 60 with higher scores indicating a worse outcome.

Measured by the User Experience (UXR) questionnaire. Includes questions from the Usability Metric for User Experience (UMUX)-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the Happiness Tracking Surveys (HaTs); an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback.

Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Stanford Expectations of Treatment Scale (SETS), an instrument for measuring positive and negative treatment expectancies. There are two subscales, the positive and negative expectancy. Scores range from 1-7, with higher scores indicating greater positive and negative expectancy.

Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Credibility/Expectancy Questionnaire (CEQ), a questionnaire for measuring cognitively-based credibility and relatively more affectively-based expectancy of therapy outcomes. Scores range from 6-60, with higher scores indicating a greater expectation of treatment success.

Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Percent of potential participants eligible to participate

Percent of eligible participants willing to participate

Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment

Adherence to program determined by average number of modules completed

Adherence to program determined by engagement with program (time spent in app)

Measured by the Patient Health Questionnaire (PHQ-8). Score range of 0 to 24 with higher scores indicating worse outcome.

* Clinically significant improvement: reduction in assessment score \>= 5
* Treatment response: 50% reduction in symptoms from pre to post-intervention
* Remission is defined as a score \< 5

Rates of adverse events and adverse advice effects

Usability measured with the System Usability Scale (SUS), which consists of 10 items, each with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores meaning more usable.

Engagement measured with the User Engagement Scale - Short Form (UES-SF), which measures self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Scores range from 1-5, with higher scores indicating more engaging material.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home-based Prehabilitation in Pancreatic Resection	NCT05496777	Preoperative Ph... Aerobic Capacit... Aerobic Fitness Functional Mobi... Cancer Weight, Body Cancer of Pancr...	Home-based preh...	18 Years -	Academisch Ziekenhuis Maastricht
Patient Recorded Indexing Measurements	NCT05899205	Cachexia Cancer Weight, Body		18 Years - 80 Years	Academisch Ziekenhuis Maastricht
Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors	NCT05826184	Weight, Body	Time restircted... Time restricted...	18 Years - 39 Years	University of Illinois at Chicago
Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management	NCT05351866	Depression Depressive Diso... Depressive Symp... Depressive Epis... Adolescent Beha... Adolescent - Em... Hematologic Dis... Oncology Weight, Body	CBT-based mobil... Mobile control ...	13 Years - 22 Years	Limbix Health, Inc.

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