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

Active, not recruiting

• Conditions: Health Behavior
• Interventions: 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

• Registration Number: NCT05434702
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study Start: 2022-06-20
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Primary Completion: 2024-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young adult cancer survivors	NHANES Food Frequency Questionnaire (FFQ)	Adolescent and young adult cancer survivors
Young adult cancer survivors	Fitbit data collection	Adolescent and young adult cancer survivors
Young adult cancer survivors	Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire	Adolescent and young adult cancer survivors
Young adult cancer survivors	Godin Exercise Leisure-Time questionnaire	Adolescent and young adult cancer survivors
Young adult cancer survivors	Digital Diet Diary	Adolescent and young adult cancer survivors
Young adult cancer survivors	Quality of Life questionnaire	Adolescent and young adult cancer survivors
Young adult cancer survivors	Zoom interviews	Adolescent and young adult cancer survivors

Primary Outcome Measures

Name	Time	Method
Aim 1: Physical Activity in YA cancer Survivors - Fitbit data	Up to 2 weeks	Frequency and intensity of physical activity will be measured using Fitbit data.
Aim 1: Quality of Life in YA Cancer Survivors -EORTC-QOL	Week 1	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
Aim 1: Quality of Life in YA Cancer Survivors -FACT-G	Week 1	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.
Aim 1: Physical Activity in YA cancer Survivors - Questionnaire	Up to 2 weeks	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).
Aim 1: Healthy eating in YA cancer survivors	Up to 2 weeks	Data from the the food frequency questionnaire along with digital diet diary will be compared to American Cancer Society dietary guidelines.

Secondary Outcome Measures

Name	Time	Method
Aim 2: Development of educational intervention for YA cancer survivors	Up to 24 months	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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States