The "COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors
Sponsor study identifier
Secondary identifiers
NIH
observational
100
1 country
1
Study Start
June 20, 2022
Actual (reported)Primary Completion
February 27, 2024
Actual (reported)Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 17, 2022
Actual (reported)June 20, 2022
Actual (reported)June 28, 2022
Actual (reported)February 27, 2024
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Aim 1: Quality of Life in YA Cancer Survivors -EORTC-QOL
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
Week 1
Aim 1: Quality of Life in YA Cancer Survivors -FACT-G
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.
Week 1
Aim 1: Physical Activity in YA cancer Survivors - Questionnaire
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).
Up to 2 weeks
Aim 1: Physical Activity in YA cancer Survivors - Fitbit data
Aim 2: Development of educational intervention for YA cancer survivors
Up to 24 months
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.
Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year.
Primarily participants in Moffitt Cancer Center's Adolescent and Young Adult Survivorship program
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Heather S.L. Jim, PhD
Moffitt Cancer Center
100 participants (actual enrollment reported by the registry).
First Submitted
June 17, 2022
First Posted
June 28, 2022
Study Start
June 20, 2022
Actual (reported)Evaluation Of Cardiovascular Health Outcomes Among Survivors 2
Creatine Supplementation and Resistance Training in Premenopausal Females
Frequency and intensity of physical activity will be measured using Fitbit data.
Up to 2 weeks
Aim 1: Healthy eating in YA cancer survivors
Data from the the food frequency questionnaire along with digital diet diary will be compared to American Cancer Society dietary guidelines.
Up to 2 weeks
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.
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.
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.
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 27, 2024
Actual (reported)Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 5, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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