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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01471483
• Other study ID #: 11-164
• Status: Active, not recruiting
• Start date: November 2011
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan-Kettering Cancer Center at Commack	Commack	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	estimate if the cancer-specific GA parameters will predict toxicity.	describe chemotherapy and surgical toxicity. We will describe the chemotherapy & surgical toxicity, estimate & correlation of toxicity with geriatric assessment variables and determine any differences between the telephone intervention vs. the control groups. We will collect 1) Grade 3-5 chemotherapy toxicity; 2) Hospitalizations; 3) Chemotherapy dose delay or reduction; 4) Percentage of patients who complete all 6 cycles of chemotherapy; 5) Percentage of patients who undergo surgical debulking (optimal, suboptimal, no surgery); 6) Surgical complications (MSKCC GYN Surgical Grading System).	2 years
Secondary	differences in the surgical and chemotherapy toxicity	nursing telephone intervention group vs. the control groups. Will describe chemotherapy & surgical toxicity, estimate any correlation of toxicity with geriatric assessment variables & determine any differences between telephone intervention vs. the control groups. Will collect 1) Grade 3-5 chemotherapy toxicity; 2) hospitalizations; 3) Chemotherapy dose delay or reduction; 4) Percentage of patients who complete all 6 cycles of chemotherapy; 5) Percentage of patients who undergo surgical debulking (optimal, suboptimal, no surgery); 6) Surgical complications (MSKCC GYN Surgical Grading System).	2 years

External Links

•   Memorial Sloan-Kettering Cancer Center