Adolescent and young adult cancer survivors

Participants will be asked to complete the Fitbit 3-day food record, which consists of inputting each food and beverage consumed for two weekdays and 1 weekend day into the Fitbit application. This digital diary includes taking photos of each food and beverage consumed during the 3 day food record period on the participant's iphone or ipad.

Digital Diet Diary

Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year.

NHANES Food Frequency Questionnaire (FFQ)

Participants will be asked to wear a Fitbit continuously (24/7) for one week to track steps and activity intensity. The Fitbit is worn on the wrist and uses accelerometer and heart rate technology to quantify steps taken and integrated barometric altimeter to measure activity intensity. The resulting Fitbit data will be automatically pulled from the participant's smartphone or study device.

Fitbit data collection

The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) includes questions about participant's quality of life during the past week, self-reported general health, self reported chronic conditions and psychological distress using a scale from 1-5, 1=excellent, 5= poor. A lower total score indicates better qualify of life.

Quality of Life questionnaire

The Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.

Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire

The Godin Exercise Leisure-Time questionnaire measures the frequency of strenuous, moderate, and mild exercise for periods of 15 minutes or more during the participant's free time throughout a typical week. The scoring using the formula leisure score index (LSI) which is obtained using the following formula: (frequency of mild × 3) + (frequency of moderate × 5) + (frequency of strenuous × 9).

Godin Exercise Leisure-Time questionnaire

A subset of 30 participants (10 African American, 10 Hispanic, 10 non-Hispanic white) will participate in semi-structured interviews to explore (a) sociocultural, environmental, and individual factors associated with lifestyle behaviors; (b) awareness of American Cancer Society (ACS) guidelines, current practices, and essential intervention modules (ex. integrating cultural foods and preferences) to provide study team with information needed to develop healthy behavior interventions for young adult cancer survivors.

Zoom interviews

Sylvia Crowder, PhD

Crystal Bryant, MPH

Heather S.L. Jim, PhD

Sylvia L Crowder, PhD

The purpose of this study is to better understand the current lifestyle behaviors that people with a young adult cancer diagnosis have after treatment. Investigators are also interested in understanding what affects the quality of life of young adult cancer survivors. Investigators will use this information to develop and test a diet and physical activity intervention to help young adult cancer survivors feel their best

"COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors

The "COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors

Quality of life will be measured using the EORTC-QOL questionnaire. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) includes questions about participant's quality of life during the past week, self-reported general health, self reported chronic conditions and psychological distress using a scale from 1-5, 1=excellent, 5= poor. A lower total score indicates better qualify of life

Quality of life will be measured using the FACT-G questionnaire. The Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.

Frequency and intensity of physical activity will be measured using the Godin Exercise leisure time questionnaire. The Godin Exercise Leisure-Time questionnaire measures the frequency of strenuous, moderate, and mild exercise for periods of 15 minutes or more during the participant's free time throughout a typical week. The scoring using the formula leisure score index (LSI) which is obtained using the following formula: (frequency of mild × 3) + (frequency of moderate × 5) + (frequency of strenuous × 9).

Frequency and intensity of physical activity will be measured using Fitbit data.

Data from the the food frequency questionnaire along with digital diet diary will be compared to American Cancer Society dietary guidelines.

Data collected from zoom interviews with a sub-set participants will be used to provide study team with information needed to develop healthy behavior interventions for young adult cancer survivors.

National Institutes of Health (NIH)

H. Lee Moffitt Cancer Center and Research Institute

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician

Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

Fitbit Data Collection

Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth

Nutrition Counseling

Participants will take a survey at baseline and weeks 4,8,12 \& 16. The questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.

Fact G Survey

Participants will take a survey at baseline and weeks 4,8,12 \& 16. The questionnaire measures participants anxiety with a scale of 0=not at all, 3=Nearly everyday.

General Anxiety Disorder (GAD)-7

Participants will take a survey at baseline and weeks 4,8,12 \& 16. The questionnaire measures participants depression with a scale of 0=not at all, 3=Nearly everyday.

Patient Health Questionnaire (PHQ)-9

Kea Turner, PhD, MPH, MA

Pamela Hodul, MD

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.

Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

The study will be deemed feasible if ≥ 50% of eligible participants are recruited

The study will be deemed feasible if ≥ 50% of participants submit study assessments

The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake

Intervention adherence will be deemed successful if ≥ 60% of participants attend recommended palliative care visits (# of visits based on provider recommendation)

Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks

Intervention adherence will be deemed successful if ≥ 60% of participants rack food intake for 8/12 weeks

Canopy Cancer Collective

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth

Participants will take a survey at baseline and weeks 4,8,12 \& 16. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.

Survey

Emma Hume

Kea Turner, PhD

Jose M Pimiento, MD

Rutika Mehta, MD, MPH

Jessica Frakes, MD

Sarah E Hoffe, MD

Jason B Fleming, MD

Jenny Permuth, PhD

Mohammed Al-Jumayli, MD

Brian Gonzalez, PhD

Nate Parker, PhD

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment

Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients

The study will be deemed feasible if ≥ 50% of eligible participants are enrolled

The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks

The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments

The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20).

The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100).

Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician for 4/6 visits

Intervention adherence will be deemed successful if ≥ 60% of participants track food intake for 8/12 weeks

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
"COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors	NCT05434702	Health Behavior	Digital Diet Di... NHANES Food Fre... Fitbit data col... Quality of Life... Functional Asse... Godin Exercise ... Zoom interviews	20 Years - 30 Years	H. Lee Moffitt Cancer Center and Research Institute
Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer	NCT05438927	Pancreatic Canc...	Fitbit Data Col... Nutrition Couns... Fact G Survey General Anxiety... Patient Health ...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients	NCT05438940	GastroEsophagea...	Fitbit Data Col... Nutrition Couns... Survey	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients	NCT05438940	GastroEsophagea...	Fitbit Data Col... Nutrition Couns... Survey	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients	NCT05438940	GastroEsophagea...	Fitbit Data Col... Nutrition Couns... Survey	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for fitbit data collection