Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery

Study Overview
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Brief Summary
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This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine whether the preoperative geriatric assessment (GA)-gynecology (GYN) score will be associated with major post-operative complications in elderly patients undergoing open primary cytoreduction surgery. SECONDARY OBJECTIVES: I. To explore associations between individual variables of the preoperative geriatric assessment and major post-operative complications in patients undergoing open primary cytoreduction surgery. II. To assess the association between the preoperative GA-GYN score and cytoreducibility defined by extent of residual disease in patients undergoing open primary cytoreduction surgery. TERTIARY OBJECTIVES : I. To evaluate whether the preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy will be associated with major postoperative complications in elderly patients undergoing open interval cytoreduction surgery. II. To describe reasons why surgeons at centers where open cytoreduction surgery is the standard of care choose to perform interval surgery vs primary surgery, and to explore the association of the preoperative GA-GYN score with the decision to perform primary surgery or interval surgery or no surgery. III. To collect the following specific information on how elderly women with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma are treated at centers that consider open cytoreduction surgery the standard of care: (1) the percentage of patients treated with primary open cytoreduction vs. interval open cytoreduction vs. no surgery and (2) to ascertain the extent of cytoreduction. IV. To determine whether neoadjuvant chemotherapy will be associated with changes in the GA-GYN score to change by comparing the GA-GYN scores obtained before and after neoadjuvant chemotherapy. V. To determine whether 30-day readmission rates after cytoreductive surgery correlate with the GA-GYN score. OUTLINE: At time of consent and within 14 days of surgery, patients complete a pre-operative geriatric assessment that evaluates functional status, comorbid medical conditions, psychological state, social support, and nutritional status. Post-operative complications are also collected for 6 weeks after surgery or until the date patients initiate or restart chemotherapy whichever is first.

Official Title
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Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers

Conditions
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Endometrial Serous Adenocarcinoma, Fallopian Tube Carcinoma, Malignant Female Reproductive System Neoplasm, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7

Intervention / Treatment
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* Other: Comprehensive Geriatric Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician Patients must have signed an approved informed consent and authorization permitting release of personal health information Patients who can understand sufficiently to be able to respond to questions posed by the study instruments Patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire NOTE: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all Post-operative pathology will not exclude patients from this study Exclusion Criteria: Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up Patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (MIS) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers Patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded Patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Observational (geriatric assessment)<br>At time of consent and within 14 days of surgery, patients complete a pre-operative geriatric assessment that evaluates functional status, comorbid medical conditions, psychological state, social support, and nutritional status. Post-operative complications are also collected for 6 weeks after surgery or until the date patients initiate or restart chemotherapy whichever is first. | Other: Comprehensive Geriatric Assessment<br>* Complete pre-operative geriatric assessment<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major post-operative complications outlined in The American College of Surgeons' National Surgical Quality Improvement Program |  | Up to 6 weeks after surgery | 
| GA-GYN score, defined as the summation of the risk score for each risk factor derived from the predictive model including 5 risk factors from the GA and 3 other risk factors | Geriatric assessment variables are used in the predictive model; the risk factors will be used to derive the total score. | Up to 14 days before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of residual disease in patients undergoing open primary cytoreduction surgery | The association between the preoperative GA-GYN score and cytoreducibility defined by extent of residual disease in patients undergoing open primary cytoreduction surgery will be assessed. Cytoreducibility is defined as complete cytoreduction (maximum dimension of residual disease =< 0.1 cm), optimal cytoreduction (maximum dimension of residual disease greater than 0.1 cm but less than or equal to 1.0 cm), or suboptimal cytoreduction (maximum dimension of residual disease greater than 1.0 cm) according to extent of residual disease. | 6 weeks after surgery | 
| Functional status, as measured by Instrumental Activities of Daily Living (IADL) | The IADL subscale consists of 7 questions rated on a 3-point Likert scale measuring the degree to which an activity can be performed independently. | Up to 14 days before surgery | 
| Functional status, as measured by Activities of Daily Living (ADL) | The ALD uses a subscale of the Medical Outcomes Study physical health with 10 questions rated on a 3-point scale. | Up to 14 days before surgery | 
| Patient's overall functioning, as measured by the physician rated performance rating scale |  | Up to 14 days before surgery | 
| Patient's overall functioning, as measured by the self-reported performance rating scale |  | Up to 14 days before surgery | 
| Number of falls in last 6 months |  | Up to 14 days before surgery | 
| Comorbidity, as measured by the Older American Resources and Services (OARS) Physical Health section | The OARS Physical Health Section is a comorbidity scale that contains a list of current illnesses and conditions an individual might have, and the degree to which they impair daily activities, rated on a 3-point scale of  not at all to  a great deal. | Up to 14 days before surgery | 
| Psychological status, as measured by the Mental Health Inventory (MHI) that is based upon the General Well-Being Scale | The full length MHI consists of 38 items grouped into the following five subscales and three global scores: anxiety, depression, general positive affect, emotional ties, and loss of behavioral emotional control, Psychological Distress (negative affect), Psychological Well-Being (positive affect), and the MHI total score a 17 item version of the MHI will be used, which will yield three global scores of Psychological Distress, Psychological Well-Being and MHI total score, as in the original 38 item MHI. | Up to 14 days before surgery | 
| Social functioning, as measured by the Medical Outcomes Study (MOS) Social Activity Limitations Measure | The four-item subscale identifies the extent to which physical or emotional problems interfere with an individual's social activities. All items are rated on a 5-point Likert scale, with response categories varying in each item. The mean of the total score is transformed to a scale of 0-100, with a higher number indicating greater support. | Up to 14 days before surgery | 
| Social support, as measured by the MOS Social Support Survey |  | Up to 14 days before surgery | 
| Nutritional status, as measured by BMI |  | Up to 14 days before surgery | 
| Nutritional status, as measured by percentage unintentional weight loss in last 6 months |  | Up to 14 days before surgery |