Geriatric Assessment and Nursing Telephone Intervention in Elderly Women With Ovarian Cancer

NCT01471483 | Completed

• 1 other identifier: 11-164
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

Older woman with ovarian cancer have a worse prognosis compared to younger patients. However, the reason is not known. Currently, the standard of care is to evaluate younger and older patients with cancer the same way. However, older patients with cancer often have more complicated issues to manage. For example, older patients often have other medical problems, take more medications, and be dependent on others for help and transportation. Too often, the medical team is unaware of these issues which can effect the patients care. The purpose of this study is to apply a set of questions designed specifically for patients with cancer who are older than 65 years of age. These questions are called a geriatric assessment. The investigators want to better understand which older patients with ovarian cancer will be able to tolerate the chemotherapy and surgery and why. This study will also see if a telephone call from a nurse who specializes in caring for older patients will improve patient care. This study will determine how feasible it is to perform geriatric assessments and telephone calls in patients with ovarian cancer.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Keywords

Geriatric Assessment; Quality of Life; 11-164; Fallopian Tubes

Outcome Measures

Primary Outcomes (2)

• feasibility of a geriatric assessment (GA)

  Geriatric Assessment Measures Selected Based on Reliability, Validity, Brevity, \& Prognostic Value. We will measure: the percentage of patients able to complete GA on their own; the length of time to complete GA; patient satisfaction with the GA, identifying items that were distressing or difficult to comprehend; the percentage of patients who completed all four serial GA;

  2 years

• feasibility of a weekly geriatric nursing telephone intervention

  the percentage of patients able to complete all weekly telephone calls; the length of time for each telephone call; patient satisfaction with the weekly telephone call.

  2 years

Secondary Outcomes (2)

• estimate if the cancer-specific GA parameters will predict toxicity.

  2 years

• differences in the surgical and chemotherapy toxicity

  2 years

Study Arms (2)

patient will receive a phone call from nurse

The proposed study will be a prospective longitudinal feasibility study of 50 older adults with a recent diagnosis of stage II, III or IV ovarian cancer who will receive standard first line chemotherapy and surgery over approximately a six-month period. Half of the 50 patients receive a weekly telephone call from geriatric nurse practitioner (NP); the remaining 25 patients would receive standard oncology care alone (randomization).

Behavioral: geriatric assessment and telephone call from nurse

patients will not receive a phone call from nurse

The proposed study will be a prospective longitudinal feasibility study of 50 older adults with a recent diagnosis of stage II, III or IV ovarian cancer who will receive standard first line chemotherapy and surgery over approximately a six-month period. Half of the 50 patients receive a weekly telephone call from geriatric nurse practitioner (NP); the remaining 25 patients would receive standard oncology care alone (randomization).

Other: geriatric assessment and no call from nurse

Interventions

geriatric assessment and telephone call from nurse BEHAVIORAL

The geriatric assessment will be completed at four time points: 1) on the day the patient receives a new chemotherapy regimen or within 30 days prior, 2) within 30 days of completion of the chemotherapy regimen (or at 12 months from study entry +/-30 days if the chemotherapy regimen is still being continued), 3) within 30 days prior to surgical debulking, and 4) 30 days after surgical debulking. The patient will receive a phone call once a week by a nurse who is an expert in caring for older patients. He/she will be asking questions about symptoms, medications and support at home. Each call is designed to last less than 30 minutes.

patient will receive a phone call from nurse

geriatric assessment and no call from nurse OTHER

The geriatric assessment will be completed at four time points: 1) on the day the patient receives a new chemotherapy regimen or within 30 days prior, 2) within 30 days of completion of the chemotherapy regimen (or at 12 months from study entry +/-30 days if the chemotherapy regimen is still being continued), 3) within 30 days prior to surgical debulking, and 4) 30 days after surgical debulking. They will not receive the phone calls, questions and symptoms will be addressed directly by the doctors and nurses on the medical and surgical teams.

patients will not receive a phone call from nurse

Eligibility Criteria

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

Study Population

The MSKCC Gynecologic clinic

You may qualify if:

• Patients must be \> or = to age of 65. Will receive platinum-based chemotherapy and surgery at MSKCC for stage II-IV ovarian, fallopian tube or peritoneal cancer.
• Pathologic confirmation or high suspicion based on Ca125 level and/or radiologic evidence of ovarian, fallopian tube or peritoneal cancer.
• Able to understand English.
• Be able to provide informed consent.

You may not qualify if:

• Enrolled on a phase I trial.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• William Tew, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 15, 2011
• Study Start: November 8, 2011
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

US (3)