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Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer

Primary Purpose

Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Medical Chart Review
Physical Performance Testing
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stage I Colorectal Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of colorectal cancer (any stage)
  • Any type of prior therapy
  • Age >= 18-39 years for AYA/young adult sample, age 40+ for older comparison group
  • For patients on active therapy: must have been diagnosed within the past three months. For survivors: must have completed curative therapy and are 6-24 months post-diagnosis
  • Speak English or Spanish
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients who are more than 3 months from diagnosis, and survivors who are more than 24 months from initial diagnosis
  • Patients who have a life expectancy of less than 6 months per their medical oncologist
  • Patients who are deemed too ill or unable to participate by their medical oncologist (e.g., have cognitive impairment or brain metastases)
  • Patients who do not speak English or Spanish

Sites / Locations

  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical function testing, questionnaire

Arm Description

Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline.

Outcomes

Primary Outcome Measures

Symptom Burden
Symptom burden will be assessed with computer adaptive tests (CATs) from the PROMIS measurement system. PROMIS is an NIH-sponsored system for measuring patient-reported health status, including physical, mental, and social well-being. Participants will complete the PROMIS Anxiety, Depression, Fatigue, and Pain Interference computer adaptive tests (CATs), which administer the minimum number of items necessary to accurately measure patient-reported outcomes while minimizing participant burden.
Change in health-related quality of life (HRQoL)
HRQoL will be measured using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life Instrument, a disease-specific quality of life measure. The FACT-C includes 38 items assessing five domains of health-related quality of life: Physical, Social/Family, Emotional and Functional Well-Being, and a subscale that examines health symptoms specific to CRC patients. Participants evaluate how they have been feeling over the preceding week on a five-point Likert-type scale with a possible total score of 0 to 136, with higher scores reflecting better QoL.

Secondary Outcome Measures

Physical function - cardiorespiratory fitness
Physical function will be measured using the following in-lab test for cardiorespiratory fitness (6-minute walk test): 6-minute Walk Test (6MWT): Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes. The investigator will follow behind the participant so as not to pace the participant, and record the distance covered. Approximate time: 10 minutes.
Physical function - power (stair climb)
Functional power will be measured using a stair climb test (Margaria Stair Climb) that has been successfully performed and correlated with lower-extremity power and mobility performance in older adults with a reliability coefficient of 0.99. Participants will be instructed to ascend a flight of 10 stairs one step at a time as quickly as possible without using a handrail. Timing will begin when one foot steps on the 3rd stair, and ends when one foot reaches the 9th stair. Time is recorded to the nearest .01 second, and an average of 3 trials is calculated. One practice trial will be given before the 3 trials. Approximate time: 5 minutes.
Physical function - Mobility
Mobility will be assessed using the Timed Up and Go (TUG) test, which has been shown to predict immediate fall risk better than static balance tests or isometric muscle strength. Participants begin seated in a chair with hands on the armrests, are asked to rise, walk to a line on the floor 3 meters from the chair, turn around, and return to the same seated position as quickly and safe as possible. Scores will be taken as the time to complete the task, with one practice trial given. An average of time for 3 trials is calculated. Approximate time: 5 minutes
Body composition
Body composition will be assessed via bioelectrical impedance using a validated device (InBody 570, Cerritos, CA). Participants will be asked to remove their shoes and socks and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on their age, sex, height, and body weight. A tape measure will be used to obtain hip circumference defined as the distance around the widest girth of the buttocks using the greater trochanter as a landmark. A tape measure will be used to obtain waist circumference defined as the distance around the midpoint between the last palpable rib and top of the iliac crest.
Biomarker analysis - insulin
Fasting insulin levels measured in blood
Biomarker analysis - glucose
Fasting glucose levels measured in blood
Biomarker analysis - C-Reactive Protein
C- reactive protein levels measured in blood

Full Information

First Posted
May 9, 2020
Last Updated
August 19, 2022
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04832763
Brief Title
Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
Official Title
Colorectal Cancer in Adolescents and Young Adults: A Pilot Study of Medical and Psychosocial Issues
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
August 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates the medical and psychosocial consequences of colorectal cancer on adolescents and young adults. Measuring physical function in adolescents and young adults with colorectal cancer may help doctors better understand the level of physical function during cancer treatment and how to improve the management of colorectal cancer in adolescents and young adults. This study may also help design a future exercise program to decrease risk factors including high blood pressure, high blood sugar, and high cholesterol.
Detailed Description
PRIMARY OBJECTIVES: I. To prospectively characterize the symptom burden and assess the health-related quality of life of adolescents and young adults (AYAs) in active treatment for colorectal cancer in comparison to older patients to identify differences that contribute to the development of appropriately timed, age appropriate interventions. II. To characterize the symptom burden and assess the health-related quality of life of AYAs who have completed curative therapy and are in surveillance for colorectal cancer compared to older patients to identify differences that contribute to the development of appropriately timed, age-appropriate interventions. SECONDARY OBJECTIVE: I. Using a prospective and cross-sectional design, characterize physical function, body composition, and biomarkers of comorbid conditions among AYAs with colorectal cancer (CRC) on active therapy and after completion of therapy in survivorship to identify targets for and timing of interventions. EXPLORATORY OBJECTIVE: I. To assess across Aims differences by cancer site (colon versus [vs.] rectal) by sex, and by race/ethnicity. OUTLINE: Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical function testing, questionnaire
Arm Type
Experimental
Arm Description
Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo collection of blood sample
Intervention Type
Other
Intervention Name(s)
Medical Chart Review
Other Intervention Name(s)
Chart Review
Intervention Description
Review of medical charts
Intervention Type
Other
Intervention Name(s)
Physical Performance Testing
Other Intervention Name(s)
Physical Fitness Testing, Physical Function Testing
Intervention Description
Undergo physical function testing
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaire
Primary Outcome Measure Information:
Title
Symptom Burden
Description
Symptom burden will be assessed with computer adaptive tests (CATs) from the PROMIS measurement system. PROMIS is an NIH-sponsored system for measuring patient-reported health status, including physical, mental, and social well-being. Participants will complete the PROMIS Anxiety, Depression, Fatigue, and Pain Interference computer adaptive tests (CATs), which administer the minimum number of items necessary to accurately measure patient-reported outcomes while minimizing participant burden.
Time Frame
Up to 6 months
Title
Change in health-related quality of life (HRQoL)
Description
HRQoL will be measured using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life Instrument, a disease-specific quality of life measure. The FACT-C includes 38 items assessing five domains of health-related quality of life: Physical, Social/Family, Emotional and Functional Well-Being, and a subscale that examines health symptoms specific to CRC patients. Participants evaluate how they have been feeling over the preceding week on a five-point Likert-type scale with a possible total score of 0 to 136, with higher scores reflecting better QoL.
Time Frame
Baseline up to 6 months
Secondary Outcome Measure Information:
Title
Physical function - cardiorespiratory fitness
Description
Physical function will be measured using the following in-lab test for cardiorespiratory fitness (6-minute walk test): 6-minute Walk Test (6MWT): Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes. The investigator will follow behind the participant so as not to pace the participant, and record the distance covered. Approximate time: 10 minutes.
Time Frame
Up to 6 months
Title
Physical function - power (stair climb)
Description
Functional power will be measured using a stair climb test (Margaria Stair Climb) that has been successfully performed and correlated with lower-extremity power and mobility performance in older adults with a reliability coefficient of 0.99. Participants will be instructed to ascend a flight of 10 stairs one step at a time as quickly as possible without using a handrail. Timing will begin when one foot steps on the 3rd stair, and ends when one foot reaches the 9th stair. Time is recorded to the nearest .01 second, and an average of 3 trials is calculated. One practice trial will be given before the 3 trials. Approximate time: 5 minutes.
Time Frame
Up to 6 months
Title
Physical function - Mobility
Description
Mobility will be assessed using the Timed Up and Go (TUG) test, which has been shown to predict immediate fall risk better than static balance tests or isometric muscle strength. Participants begin seated in a chair with hands on the armrests, are asked to rise, walk to a line on the floor 3 meters from the chair, turn around, and return to the same seated position as quickly and safe as possible. Scores will be taken as the time to complete the task, with one practice trial given. An average of time for 3 trials is calculated. Approximate time: 5 minutes
Time Frame
Up to 6 months
Title
Body composition
Description
Body composition will be assessed via bioelectrical impedance using a validated device (InBody 570, Cerritos, CA). Participants will be asked to remove their shoes and socks and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on their age, sex, height, and body weight. A tape measure will be used to obtain hip circumference defined as the distance around the widest girth of the buttocks using the greater trochanter as a landmark. A tape measure will be used to obtain waist circumference defined as the distance around the midpoint between the last palpable rib and top of the iliac crest.
Time Frame
Up to 6 months
Title
Biomarker analysis - insulin
Description
Fasting insulin levels measured in blood
Time Frame
Up to 6 months
Title
Biomarker analysis - glucose
Description
Fasting glucose levels measured in blood
Time Frame
Up to 6 months
Title
Biomarker analysis - C-Reactive Protein
Description
C- reactive protein levels measured in blood
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of colorectal cancer (any stage) Any type of prior therapy Age >= 18-39 years for AYA/young adult sample, age 40+ for older comparison group For patients on active therapy: must have been diagnosed within the past three months. For survivors: must have completed curative therapy and are 6-24 months post-diagnosis Speak English or Spanish Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Patients who are more than 3 months from diagnosis, and survivors who are more than 24 months from initial diagnosis Patients who have a life expectancy of less than 6 months per their medical oncologist Patients who are deemed too ill or unable to participate by their medical oncologist (e.g., have cognitive impairment or brain metastases) Patients who do not speak English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Miller, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer

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