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NCT Number: NCT05434702

"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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Diet Diary

Behavioral

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)

Behavioral

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

Fitbit Data Collection

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Aim 1: Quality of Life in YA Cancer Survivors -EORTC-QOL

    Time frame: 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

  2. Aim 1: Quality of Life in YA Cancer Survivors -FACT-G

    Time frame: 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.

  3. Aim 1: Physical Activity in YA cancer Survivors - Questionnaire

    Time frame: 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).

  4. Aim 1: Physical Activity in YA cancer Survivors - Fitbit data

    Time frame: Up to 2 weeks

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

  5. Aim 1: Healthy eating in YA cancer survivors

    Time frame: 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 outcomes

  1. Aim 2: Development of educational intervention for YA cancer survivors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Jun 28, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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