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

NCT05434702 | Active Not Recruiting

• 2 other identifiers: MCC-21786R03CA270475
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Health Behavior

Keywords

Young Adult; Cancer survivor

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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).

  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.

  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.

  Up to 2 weeks

Secondary Outcomes (1)

• Aim 2: Development of educational intervention for YA cancer survivors

  Up to 24 months

Study Arms (1)

Young adult cancer survivors

Adolescent and 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 interviews

Interventions

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.

Young adult cancer survivors

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.

Young adult cancer survivors

NHANES Food Frequency Questionnaire (FFQ) BEHAVIORAL

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

Young adult cancer survivors

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.

Young adult cancer survivors

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.

Young adult cancer survivors

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).

Young adult cancer survivors

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.

Young adult cancer survivors

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primarily participants in Moffitt Cancer Center's Adolescent and Young Adult Survivorship program

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Health Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Heather S.L. Jim, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: June 20, 2022
• Primary Completion: February 27, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)