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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434702
• Other study ID #: MCC-21786
• Secondary ID: R03CA270475
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

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.
• NHANES Food Frequency Questionnaire (FFQ)
Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year.
• 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.
• 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.
• 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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

•   Moffitt Cancer Center Clinical Trials website