Geriatric Assessment and Nursing Telephone Intervention in Elderly Women With Ovarian Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPeritoneal Cancer
- Interventions
- Other: geriatric assessment and no call from nurseBehavioral: geriatric assessment and telephone call from nurse
- Registration Number
- NCT01471483
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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.
- Enrolled on a phase I trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients will not receive a phone call from nurse geriatric assessment and no 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). patient will receive a phone call from nurse geriatric assessment and telephone 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).
- Primary Outcome Measures
Name Time Method feasibility of a geriatric assessment (GA) 2 years 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;
feasibility of a weekly geriatric nursing telephone intervention 2 years 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.
- Secondary Outcome Measures
Name Time Method estimate if the cancer-specific GA parameters will predict toxicity. 2 years 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).
differences in the surgical and chemotherapy toxicity 2 years 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).
Trial Locations
- Locations (3)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, 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