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

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ClinicalTrials.gov Identifier: NCT02315469
Recruitment Status : Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Tracking Information
First Submitted Date December 9, 2014
First Posted Date December 11, 2014
Last Update Posted Date February 16, 2018
Actual Study Start Date February 10, 2015
Actual Primary Completion Date March 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2018)
  • 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 [ Time Frame: Up to 14 days before surgery ]
    Geriatric assessment variables are used in the predictive model; the risk factors will be used to derive the total score.
  • Occurrence of major post-operative complications outlined in The American College of Surgeons? National Surgical Quality Improvement Program [ Time Frame: Up to 6 weeks after surgery ]
Original Primary Outcome Measures
 (submitted: December 9, 2014)
  • Occurrence of major post-operative complications outlined in The American College of Surgeons' National Surgical Quality Improvement Program [ Time Frame: 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 [ Time Frame: Up to 14 days before surgery ]
    Geriatric assessment variables are used in the predictive model; the risk factors will be used to derive the total score.
Change History Complete list of historical versions of study NCT02315469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 14, 2018)
  • Comorbidity, as measured by the Older American Resources and Services (OARS) Physical Health section [ Time Frame: Up to 14 days before surgery ]
    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.?
  • Extent of residual disease in patients undergoing open primary cytoreduction surgery [ Time Frame: 6 weeks after 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.
  • Functional status, as measured by Activities of Daily Living (ADL) [ Time Frame: Up to 14 days before surgery ]
    The ALD uses a subscale of the Medical Outcomes Study physical health with 10 questions rated on a 3-point scale.
  • Functional status, as measured by Instrumental Activities of Daily Living (IADL) [ Time Frame: Up to 14 days before surgery ]
    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.
  • Number of falls in last 6 months [ Time Frame: Up to 14 days before surgery ]
  • Nutritional status, as measured by BMI [ Time Frame: Up to 14 days before surgery ]
  • Nutritional status, as measured by percentage unintentional weight loss in last 6 months [ Time Frame: Up to 14 days before surgery ]
  • Patient?s overall functioning, as measured by the physician rated performance rating scale [ Time Frame: Up to 14 days before surgery ]
  • Patient?s overall functioning, as measured by the self-reported performance rating scale [ Time Frame: 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 [ Time Frame: Up to 14 days before surgery ]
    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.
  • Social functioning, as measured by the Medical Outcomes Study (MOS) Social Activity Limitations Measure [ Time Frame: Up to 14 days before surgery ]
    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.
  • Social support, as measured by the MOS Social Support Survey [ Time Frame: Up to 14 days before surgery ]
Original Secondary Outcome Measures
 (submitted: December 9, 2014)
  • Extent of residual disease in patients undergoing open primary cytoreduction surgery [ Time Frame: 6 weeks after 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.
  • Functional status, as measured by Instrumental Activities of Daily Living (IADL) [ Time Frame: Up to 14 days before surgery ]
    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.
  • Functional status, as measured by Activities of Daily Living (ADL) [ Time Frame: Up to 14 days before surgery ]
    The ALD uses a subscale of the Medical Outcomes Study physical health with 10 questions rated on a 3-point scale.
  • Patient's overall functioning, as measured by the physician rated performance rating scale [ Time Frame: Up to 14 days before surgery ]
  • Patient's overall functioning, as measured by the self-reported performance rating scale [ Time Frame: Up to 14 days before surgery ]
  • Number of falls in last 6 months [ Time Frame: Up to 14 days before surgery ]
  • Comorbidity, as measured by the Older American Resources and Services (OARS) Physical Health section [ Time Frame: Up to 14 days before surgery ]
    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."
  • Psychological status, as measured by the Mental Health Inventory (MHI) that is based upon the General Well-Being Scale [ Time Frame: Up to 14 days before surgery ]
    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.
  • Social functioning, as measured by the Medical Outcomes Study (MOS) Social Activity Limitations Measure [ Time Frame: Up to 14 days before surgery ]
    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.
  • Social support, as measured by the MOS Social Support Survey [ Time Frame: Up to 14 days before surgery ]
  • Nutritional status, as measured by BMI [ Time Frame: Up to 14 days before surgery ]
  • Nutritional status, as measured by percentage unintentional weight loss in last 6 months [ Time Frame: Up to 14 days before surgery ]
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2015)
  • 30-day readmission after cytoreduction surgery [ Time Frame: Up to 30 days after surgery ]
    Will explore the correlation between pre-surgery GA-GYN score and dichotomized 30-day readmission.
  • Frequency of patients treated with primary cytoreduction, interval cytoreduction, no surgery and the extent of surgery [ Time Frame: 6 weeks after surgery ]
  • Frequency of reasons why surgeons perform interval surgery vs primary surgery and preoperative GA-GYN score [ Time Frame: 6 weeks after surgery ]
  • Preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy [ Time Frame: Up to 14 days before surgery ]
Original Other Pre-specified Outcome Measures
 (submitted: December 9, 2014)
  • Frequency of reasons why surgeons perform interval surgery vs primary surgery and preoperative GA-GYN score [ Time Frame: 6 weeks after surgery ]
  • Frequency of patients treated with primary cytoreduction, interval cytoreduction, no surgery and the extent of surgery [ Time Frame: 6 weeks after surgery ]
  • Preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy [ Time Frame: Up to 14 days before surgery ]
  • 30-day readmission after cytoreduction surgery [ Time Frame: Up to 30 days after surgery ]
    Will explore the correlation between pre-surgery GA-GYN score and dichotomized 30-day readmission.
 
Descriptive Information
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
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • Endometrial Serous Adenocarcinoma
  • Fallopian Tube Carcinoma
  • 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
  • Other: Comprehensive Geriatric Assessment
    Complete pre-operative geriatric assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Groups/Cohorts Observational (geriatric assessment)
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.
Interventions:
  • Other: Comprehensive Geriatric Assessment
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 14, 2018)
190
Original Estimated Enrollment
 (submitted: December 9, 2014)
228
Study Completion Date Not Provided
Actual Primary Completion Date March 15, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02315469
Other Study ID Numbers NRG-CC002
NCI-2014-01376 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-ELD1301
NRG-CC002 ( Other Identifier: NRG Oncology )
NRG-CC002 ( Other Identifier: DCP )
NRG-CC002 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
UG1CA189867 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NRG Oncology
Study Sponsor NRG Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Amina Ahmed NRG Oncology
PRS Account NRG Oncology
Verification Date February 2018