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

  • STATUS
    Recruiting
  • End date
    Sep 22, 2023
  • participants needed
    119
  • sponsor
    University of Southern California
Updated on 16 April 2021

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.

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.

Details
Condition 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, 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
Treatment questionnaire administration, quality-of-life assessment, medical chart review, biospecimen collection, Physical Performance Testing
Clinical Study IdentifierNCT04832763
SponsorUniversity of Southern California
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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