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

February 3, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Week 1
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.
Week 1
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).
Up to 2 weeks
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.
Up to 2 weeks
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.
Up to 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather S.L. Jim, PhD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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