Preserving Fertility After Colorectal Cancer Study

Study Overview
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Brief Summary
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The PREFACE Study is a prospective, longitudinal cohort study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.

Detailed Description
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The Preserving Fertility After Colorectal Cancer (PREFACE) Study comprehensively investigates fertility, sexual health and clinical outcomes along the cancer care continuum among individuals diagnosed with colorectal cancer between age 18 to 49 years. Patients are recruited prior to colorectal cancer therapy [baseline] and followed for up to 36 months after completion of first-course therapy (or 45 months after diagnosis for patients on maintenance therapy). Study timepoints are defined at: (i) completion of first-course treatment (or 9 months after diagnosis for patients on maintenance therapy [treatment]); (ii) and at 9, 18 and 36 month intervals thereafter [surveillance]. This cohort is enriched by a robust collection of biospecimens and data.

Official Title
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Preserving Fertility After Colorectal Cancer: The PREFACE Study

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known diagnosis of colorectal cancer Age 18 to 49 years at colorectal cancer diagnosis Diagnosed by and/or consulting with a physician participating in the PREFACE Study No prior history of colorectal cancer and/or colorectal cancer treatment Mentally and physically able to consent and participate in the study Exclusion Criteria: Women who are pregnant at the time of colorectal cancer diagnosis Prisoners Unable to provide informed consent Unable to read, write, or complete questionnaires in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PREFACE: Vanderbilt-Ingram Cancer Center<br>Patient recruitment and follow-up, longitudinal collection of data and multiple biospecimen at pre-defined study timepoints, objective assessment of health behaviors/habits, individual interviews. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change(s) in serum hormonal markers | For female patients not taking oral contraceptive pills (OCPs), serum hormonal markers to be measured include: anti-Mullerian hormone (AMH), estrogens, sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and androgens. For male patients, serum hormonal markers to be measured include: inhibin B, FSH, androgens, estrogens, SHBG and LH. | Baseline, treatment and multiple surveillance timepoints (up to 5 years) | 
| Reproductive health history (Questionnaire) |  | Baseline timepoint | 
| Change(s) in reproductive health (Questionnaire) |  | Baseline, treatment and multiple surveillance timepoints (up to 5 years) | 
| Sexual health history (Questionnaire) |  | Baseline timepoint | 
| Changes in sexual health (Questionnaire) |  | Baseline, treatment and multiple surveillance timepoints (Up to 5 years) | 
| Sexual health (Interview) |  | 9 month post-treatment/Surveillance timepoint | 
| Disease-free survival |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change(s) in health-related quality of life (Questionnaire) |  | At baseline, treatment and multiple surveillance timepoints (Up to 5 years) | 
| Physical activity (Accelerometer) |  | Baseline timepoint | 
| Physical activity (Accelerometer) |  | Completion of first-course treatment (or 9 months after baseline) | 
| Physical activity (Accelerometer) |  | 9 month post-treatment/Surveillance timepoint | 
| Physical activity (Accelerometer) |  | 18 month post-treatment/Surveillance timepoint | 
| Physical activity (Accelerometer) |  | 36 month post-treatment/Surveillance timepoint |