Clinical trial · Observational
Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery
Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
NCT02315469CI-TRIAL-00055213completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Serous Adenocarcinoma | Endometrial Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIIA Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Geriatric Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Other: Comprehensive Geriatric Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Occurrence of major post-operative complications outlined in The American College of Surgeons' National Surgical Quality Improvement Program
- timeFrame
- Up to 6 weeks after surgery
- measure
- 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
- timeFrame
- Up to 14 days before surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.