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NCT Number: NCT01471483

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. feasibility of a geriatric assessment (GA)

    Time frame: 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;

  2. feasibility of a weekly geriatric nursing telephone intervention

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. differences in the surgical and chemotherapy toxicity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2011
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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