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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05434702
Enrollment
100
Registered
2022-06-28
Start date
2022-06-20
Completion date
2027-03-01
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

Young Adult, Cancer survivor

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

Interventions

BEHAVIORALDigital 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.

BEHAVIORALNHANES Food Frequency Questionnaire (FFQ)

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

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.

BEHAVIORALQuality 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.

BEHAVIORALFunctional 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.

BEHAVIORALGodin 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).

BEHAVIORALZoom 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.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Aim 1: Quality of Life in YA Cancer Survivors -EORTC-QOLWeek 1Quality 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-GWeek 1Quality 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 - QuestionnaireUp to 2 weeksFrequency 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 dataUp to 2 weeksFrequency and intensity of physical activity will be measured using Fitbit data.
Aim 1: Healthy eating in YA cancer survivorsUp to 2 weeksData from the the food frequency questionnaire along with digital diet diary will be compared to American Cancer Society dietary guidelines.

Secondary

MeasureTime frameDescription
Aim 2: Development of educational intervention for YA cancer survivorsUp to 24 monthsData 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHeather S.L. Jim, PhD

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026