Health BehaviorNCT05434702
"COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors
An observational study of Health Behavior, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Digital Diet Diary, NHANES Food Frequency Questionnaire (FFQ) and Fitbit data collection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Primarily participants in Moffitt Cancer Center's Adolescent and Young Adult Survivorship program
Who may be able to join
- 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
Who cannot join
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Health Behavior
- Being tested
- Digital Diet Diary, NHANES Food Frequency Questionnaire (FFQ), Fitbit data collection, Quality of Life questionnaire, Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
- Keywords
- Young Adult, Cancer survivor
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Diet DiaryBehavioural
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)Behavioural
Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year.
Fitbit data collectionBehavioural
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 questionnaireBehavioural
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) QuestionnaireBehavioural
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 questionnaireBehavioural
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 interviewsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Young adult cancer survivors | Adolescent and young adult cancer survivors Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 2 weeks
Secondary outcomes (1)
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start20 Jun 2022
- Primary completion27 Feb 2024
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Heather S.L. Jim, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434702
- Sponsor's protocol ID
- MCC-21786
- Other IDs
- R03CA270475
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors
- ClinicalTrials.gov ID
- NCT05434702
- Acronym / sponsor ID
- MCC-21786
- Conditions
- Health Behavior
- Keywords
- Young Adult, Cancer survivor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adult cancer survivors | – | 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 interviewsAdolescent and young adult cancer survivors |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primarily participants in Moffitt Cancer Center's Adolescent and Young Adult Survivorship program
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Women who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Diet DiaryParticipants 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. | Behavioural | Young adult cancer survivors |
| NHANES Food Frequency Questionnaire (FFQ)Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year. | Behavioural | Young adult cancer survivors |
| Fitbit data collectionParticipants 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. | Behavioural | Young adult cancer survivors |
| Quality of Life questionnaireThe 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. | Behavioural | Young adult cancer survivors |
| Functional Assessment of Cancer Therapy - General (FACT-G) QuestionnaireThe 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. | Behavioural | Young adult cancer survivors |
| Godin Exercise Leisure-Time questionnaireThe 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). | Behavioural | Young adult cancer survivors |
| Zoom interviewsA 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. | Behavioural | Young adult cancer survivors |
Primary outcome
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
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.
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).
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.
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.
1 secondary outcome
Aim 2: Development of educational intervention for YA cancer survivors
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather S.L. Jim, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Quality of Life in YA Cancer Survivors -EORTC-QOL (time frame: Week 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.