Colorectal Cancer in Adolescents and Young Adults: A Pilot Study of Medical and Psychosocial Issues
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Symptom Burden
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Medical Chart Review (Other)
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.
干预措施: Physical Performance Testing (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Symptom Burden
时间窗: Up to 6 months
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.
Change in health-related quality of life (HRQoL)
时间窗: Baseline up to 6 months
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.
次要结局
- 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)
- Biomarker analysis - glucose(Up to 6 months)
- Biomarker analysis - C-Reactive Protein(Up to 6 months)