"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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: Digital Diet Diary; Behavioral: NHANES Food Frequency Questionnaire (FFQ); Behavioral: Fitbit data collection; Behavioral: Quality of Life questionnaire; Behavioral: Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire; Behavioral: Godin Exercise Leisure-Time questionnaire; Behavioral: Zoom interviews

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primarily participants in Moffitt Cancer Center's Adolescent and Young Adult Survivorship program

Description

Inclusion Criteria:

• Diagnosed with cancer between the ages of 19 and 29
• Currently between the ages of 20 and 30 years old
• At least 1 year post-adjuvant therapy
• Able to read/speak English
• Able to complete an online survey
• Able to consume food orally

Exclusion Criteria:

• Women who are pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Young adult cancer survivors; Adolescent and young adult cancer survivors

Behavioral: Digital Diet Diary; 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.; Behavioral: NHANES Food Frequency Questionnaire (FFQ); Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year.; Behavioral: Fitbit data collection; 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.; Behavioral: Quality of Life 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.; Behavioral: Functional Assessment of Cancer Therapy - General (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.; Behavioral: 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).; Behavioral: Zoom interviews; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 2: Development of educational intervention for YA cancer survivors	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.	Up to 24 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Heather S.L. Jim, PhD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): February 27, 2024
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer survivor; Young Adult
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: MCC-21786; R03CA270475 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No