PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

NCT06089083 | Recruiting

• 4 other identifiers: 23407NCI-2023-07434R03AG088902K12HD001262
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

This study seeks to understand how frailty, a term that describes people who are more vulnerable stressors such as a new medical problem, affects the outcomes and quality of life in adult patients with gynecologic cancer.

Conditions

Malignant Female Reproductive System Neoplasm; Gynecologic Cancer; Gynecologic Neoplasm

Keywords

Frailty; Risk Factors

Outcome Measures

Primary Outcomes (3)

• Proportion of participants who are categorized as frail

  The Fried frailty phenotype (FP) assesses physical frailty through five criteria: unintentional weight loss; weakness or poor handgrip strength; self-reported exhaustion; slow walking speed; and low physical activity. Participants who receive a score of \>3 will be categorized as 'frail'. Participants who receive a score \<=3 will be categorized as Non-frail at time of enrollment.

  At time of enrollment, 1 day

• Demographic risk factors associated with those who screen positive for frailty

  Demographic risk factors obtained from medical record review (i.e. sex, age, race, ethnicity, cancer type, cancer histology, cancer stage, comorbidities, etc.) will be assessed and analyzed for differences between participants categorized as frail versus non-frail.

  At time of enrollment, 1 day

• Oncologic risk factors associated with those who screen positive for frailty

  Risk factors determined to be oncologic in nature will be assessed and analyzed for differences between participants categorized as frail versus non-frail.

  At time of enrollment, 1 day

Secondary Outcomes (8)

• Mean number of healthy days at home

  Up to 10 years

• Mean length of hospital stay

  Up to 10 years

• Percentage of participants readmitted to hospital

  Up to 10 years

• Percentage of participants with reported surgical complications

  Up to 10 years

• Mean time to initiation of standard of care chemotherapy

  Up to 10 years

Study Arms (1)

Newly diagnosed gynecologic cancer

Participants will undergo physical function assessments, complete surveys, and medical records every 3 months +/- 4 weeks prior to standard of care surgery (outside of this protocol). After surgery subjects will be followed for at least 3 months +/- 4 weeks for up to one year after diagnosis. Medical record reviews will occur periodically to examine for long-term follow up oncologic outcomes of progression free survival, overall survival, and chemotherapy delays for up to 10 years after enrollment.

Other: Physical function assessment; Other: Self-reported Assessments and Questionnaires; Procedure: Surgery (Standard of Care, Non-Interventional)

Interventions

Physical function assessment OTHER

Physical assessments of frailty will be conducted in person.

Newly diagnosed gynecologic cancer

Self-reported Assessments and Questionnaires OTHER

Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study

Also known as: Questionnaires

Newly diagnosed gynecologic cancer

Surgery (Standard of Care, Non-Interventional) PROCEDURE

Surgical data will be reviewed via medical record

Also known as: Surgical Procedure

Newly diagnosed gynecologic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing evaluation for a newly diagnosed gynecologic malignancy

You may qualify if:

• Age 18 years or greater
• Undergoing evaluation for a newly diagnosed gynecologic malignancy
• Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it

You may not qualify if:

• Contraindication to any study-related procedure or assessment
• Does not speak a language for which the consent form and study materials are available

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, San Francisco: lead
• Conquer Cancer Foundation: collaborator
• American Society of Clinical Oncology: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Genital Neoplasms, Female; Frailty

Interventions

Surveys and Questionnaires; Surgical Procedures, Operative; Standard of Care

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Quality Indicators, Health Care; Health Services Administration

Study Officials

• Stephanie Cham, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Titzler

CONTACT

415-353-9600; janet.titzler@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2033
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)