Clinical trial NCT04832763: 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
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-04-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Symptom Burden
timeFrame: Up to 6 months
measure: Change in health-related quality of life (HRQoL)
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Physical function - cardiorespiratory fitness
timeFrame: Up to 6 months
measure: Physical function - power (stair climb)
timeFrame: Up to 6 months
measure: Physical function - Mobility
timeFrame: Up to 6 months
measure: Body composition
timeFrame: Up to 6 months
measure: Biomarker analysis - insulin
timeFrame: Up to 6 months
measure: Biomarker analysis - glucose
timeFrame: Up to 6 months
measure: Biomarker analysis - C-Reactive Protein
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Kimberly Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: