Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
NCT ID: NCT04832763
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
32 participants
INTERVENTIONAL
2019-09-27
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Physical function testing, questionnaire
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.
Biospecimen Collection
Undergo collection of blood sample
Medical Chart Review
Review of medical charts
Physical Performance Testing
Undergo physical function testing
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaire
Interventions
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Biospecimen Collection
Undergo collection of blood sample
Medical Chart Review
Review of medical charts
Physical Performance Testing
Undergo physical function testing
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Kimberly Miller, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2020-02581
Identifier Type: REGISTRY
Identifier Source: secondary_id
3C-19-4
Identifier Type: OTHER
Identifier Source: secondary_id
3C-19-4
Identifier Type: -
Identifier Source: org_study_id