Overview

This trial is active, not recruiting.

Conditions ovarian cancer, peritoneal cancer, fallopian tube cancer
Treatments geriatric assessment and telephone call from nurse, geriatric assessment and no call from nurse
Sponsor Memorial Sloan Kettering Cancer Center
Start date November 2011
End date November 2017
Trial size 50 participants
Trial identifier NCT01471483, 11-164

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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).
geriatric assessment and telephone call from nurse
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.
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).
geriatric assessment and no call from nurse
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.

Primary Outcomes

Measure
feasibility of a geriatric assessment (GA)
time frame: 2 years
feasibility of a weekly geriatric nursing telephone intervention
time frame: 2 years

Secondary Outcomes

Measure
estimate if the cancer-specific GA parameters will predict toxicity.
time frame: 2 years
differences in the surgical and chemotherapy toxicity
time frame: 2 years

Eligibility Criteria

Female participants at least 65 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - Enrolled on a phase I trial.

Additional Information

Official title Geriatric Assessment and Nursing Telephone Intervention in Elderly Women With Ovarian Cancer
Principal investigator William Tew, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.