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

NCT04832763 | Active Not Recruiting DMC

• 3 other identifiers: 3C-19-4NCI-2020-02581P30CA014089
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 6 months

• 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.

  Baseline up to 6 months

Secondary Outcomes (7)

• Physical function - cardiorespiratory fitness

  Up to 6 months

• Physical function - power (stair climb)

  Up to 6 months

• Physical function - Mobility

  Up to 6 months

• Body composition

  Up to 6 months

• Biomarker analysis - insulin

  Up to 6 months

Study Arms (1)

Physical function testing, questionnaire

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Medical Chart Review; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood sample

Physical function testing, questionnaire

Medical Chart Review OTHER

Review of medical charts

Also known as: Chart Review

Physical function testing, questionnaire

Physical Performance Testing OTHER

Undergo physical function testing

Also known as: Physical Fitness Testing, Physical Function Testing

Physical function testing, questionnaire

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Physical function testing, questionnaire

Questionnaire Administration OTHER

Complete questionnaire

Physical function testing, questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Kimberly Miller, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: April 6, 2021
• Study Start: September 27, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (2)