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Active Not RecruitingNCT05434702

"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
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
Sex
All
Age
20 Years – 30 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALDigital 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.
BEHAVIORALNHANES Food Frequency Questionnaire (FFQ)Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year.
BEHAVIORALFitbit 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.
BEHAVIORALQuality 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.
BEHAVIORALFunctional 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.
BEHAVIORALGodin 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).
BEHAVIORALZoom 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.

Timeline

Start date
2022-06-20
Primary completion
2024-02-27
Completion
2027-03-01
First posted
2022-06-28
Last updated
2026-02-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05434702. Inclusion in this directory is not an endorsement.