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

Brief Title

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

Official Title

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

Brief Summary

      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

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.

Study Type

Observational

Primary Outcome

Occurrence of major post-operative complications outlined in The American College of Surgeons' National Surgical Quality Improvement Program

Secondary Outcome

 Extent of residual disease in patients undergoing open primary cytoreduction surgery

Condition

Endometrial Serous Adenocarcinoma

Intervention

Comprehensive Geriatric Assessment

Study Arms / Comparison Groups

 Observational (geriatric assessment)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

Start Date

February 10, 2015

Completion Date

February 9, 2019

Primary Completion Date

March 15, 2016

Eligibility Criteria

        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

Gender

Female

Ages

70 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Amina Ahmed, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT02315469

Organization ID

NRG-CC002

Secondary IDs

NCI-2014-01376

Responsible Party

Sponsor

Study Sponsor

NRG Oncology

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Amina Ahmed, Principal Investigator, NRG Oncology

Verification Date

September 2020