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Stage I Colorectal Cancer AJCC v8NCT04832763

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

A study testing Biospecimen Collection, Medical Chart Review and Physical Performance Testing in people with Stage I Colorectal Cancer AJCC v8 and Stage II Colorectal Cancer AJCC v8, run by University of Southern California at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Medical Chart Review and Physical Performance Testing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
27 Sep 2019to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Colorectal Cancer in Adolescents and Young Adults: A Pilot Study of Medical and Psychosocial Issues

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Medical Chart Review, Physical Performance Testing, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Undergo collection of blood sample

  • Medical Chart ReviewOther

    Also called Chart Review

    Review of medical charts

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Undergo physical function testing

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Complete questionnaire

Study groups in NCT04832763
Study groupRoleWhat they receive
Physical function testing, questionnaireExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Other: Medical Chart Review; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 months

  2. 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.

    Measured: Baseline up to 6 months

Secondary outcomes (7)

  1. 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.

    Measured: Up to 6 months

  2. 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.

    Measured: Up to 6 months

  3. 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

    Measured: Up to 6 months

  4. 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.

    Measured: Up to 6 months

  5. Biomarker analysis - insulin

    Fasting insulin levels measured in blood

    Measured: Up to 6 months

  6. Biomarker analysis - glucose

    Fasting glucose levels measured in blood

    Measured: Up to 6 months

  7. Biomarker analysis - C-Reactive Protein

    C- reactive protein levels measured in blood

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2021
  2. Study start27 Sep 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04832763
Sponsor's protocol ID
3C-19-4
Other IDs
NCI-2020-02581, 3C-19-4, P30CA014089
Status last verified
Jun 2026
First submitted
9 May 2020
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Medical Chart Review and Physical Performance Testing in people with Stage I Colorectal Cancer AJCC v8 and Stage II Colorectal Cancer AJCC v8, run by University of Southern California at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Burden (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04832763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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