The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Cytomegalovirus (CMV), a widely prevalent virus in the general US population, has been shown to be associated with increased inflammation and mortality. Previous small pilot studies have demonstrated that latent CMV may be reactivated during chemotherapy in cancer patients, and may be associated with unfavorable cancer outcomes such as fatigue and increased mortality. The central research idea for this study, supported by previous preliminary data, is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer that impacts patient outcomes. The overarching goals of this observational study are: To assess how CMV infection is associated with ovarian cancer symptoms over the course of the disease and its treatment. To describe the relationship between CMV reactivation in ovarian cancer patients, survival, fatigue, and other QOL outcomes, both cross-sectionally and longitudinally.

Official Title
-----------------
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

Conditions
-----------------
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 Ability to read and write in English women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer Treatment plan includes chemotherapy Able to provide written voluntary consent before performance of any study related procedure. Cohort 1 only: within 2 years of completing initial chemotherapy treatment Cohort 2 only: prior to starting chemotherapy Exclusion Criteria: Inability to provide informed written consent Previous exposure to chemotherapy Life expectancy < 3 months or in hospice care or nursing home

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 - Cross-sectional (within 2 years of diagnosis)<br>Individuals diagnosed and treated for ovarian cancer in past two years, will complete 1 study measure | |
| Cohort 2- Prospective (from diagnosis)<br>Individuals newly diagnosed with ovarian cancer, will complete 3 study measures (baseline/diagnosis, completion of chemotherapy, one year post-diagnosis) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1 - Cancer-related fatigue | Cancer-related fatigue will be measured using the Fatigue Symptom Inventory. The scale is composed of 14 items (one is not scored). A total Disruption Index is calculated by summing items 5-11 (each item ranges from 0-10). A lower score indicates lower fatigue. Possible range is 0-70. | post treatment | 
| Cohort 2 - Recurrence-free survival | Time from diagnosis to first known recurrence or death, censored at least follow-up if recurrence free and alive | 3 years |