Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Sponsor
Population Health Research Institute
Study ID
NCT05738252
Status
Recruiting
Apply to this trial

Conditions

  • Frailty
  • Gynecologic Cancer
  • Oncology

Eligibility Criteria

Sex
FEMALE
Age
55 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Clinical Frailty Scale — DIAGNOSTIC_TEST
    A way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician
  • Frailty Phenotype — DIAGNOSTIC_TEST
    Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity

Study Details

FARGO is a prospective cohort study that aims to determine the performance of preoperative frailty assessment based on the Frailty Phenotype (FP), compared to a perioperative cardiovascular risk assessment based on the combination of preoperative Revised Cardiac Risk Index (RCRI), age and occurrence of myocardial injury after noncardiac surgery (MINS), in predicting the composite of all-cause death or new disability at 6 months after surgery in patients aged 55 or older. Patients will have confirmed or suspected gynecologic cancer, undergoing cytoreductive or high-risk surgery with or without chemotherapy.

Key Dates

First listed
Feb 22, 2023
Start date
Jun 15, 2023
Status verified
Apr 2025
Primary completion
May 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
280 participants (estimated)

Arms

  • Arm: Group A
    We expect that some of the eligible patients (Group A) will undergo surgery without NACT. Group A will undergo only one preoperative study visit (baseline) within 45 days prior to their surgery. Group A will complete the study assessments and follow-ups. Some patients of Group A will undergo adjuvant chemotherapy after surgery; this will not affect their study timeline.
  • Arm: Group B
    Patients undergoing NACT before their surgery (group B) will have a first baseline study assessment within 45 days prior to their first chemotherapy treatment; in this group, a second preoperative study visit will be repeated after chemotherapy is considered terminated at least 18 days post-chemotherapy cycle and within 45 days prior to surgery. Group B will complete the study assessments and follow-ups. Some patients of Group B will undergo adjuvant chemotherapy after surgery; this will not affect their study timeline.
  • Arm: Group C
    Post-chemotherapy, a small proportion of patients will not be deemed eligible for surgery by the treating physician (group C). Group C will be included in the evaluation of chemotherapy-related outcomes, and will also be asked to complete a follow-up visit 6 months from the date of registration
  • Arm: Group D
    An even smaller proportion of patients will initially be deemed eligible, recruited, and will complete the baseline assessment; however, they will eventually not undergo neither surgery nor chemotherapy. For Group D, a follow-up visit at 6 months from the baseline visit will be completed.

Primary Outcome Measure

All-cause death or new disability at 6 months [ Time Frame: 6 months ]

Central Contacts

Related Studies