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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01471483
First received: November 10, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Behavioral: geriatric assessment and telephone call from nurse
Other: geriatric assessment and no call from nurse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Geriatric Assessment and Nursing Telephone Intervention in Elderly Women With Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility of a geriatric assessment (GA) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • estimate if the cancer-specific GA parameters will predict toxicity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
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
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The MSKCC Gynecologic clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471483

Contacts
Contact: William Tew, MD 646-888-4211
Contact: Beatriz Korc-Grodzicki, MD 646-888-3154

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: William Tew, MD    646-888-4211      
Memorial Sloan-Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: William Tew, MD    646-888-4211      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: William Tew, MD    646-888-4211      
Contact: Beatriz Korc-Grodzicki, MD    646-888-3154      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: William Tew, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01471483     History of Changes
Other Study ID Numbers: 11-164
Study First Received: November 10, 2011
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Geriatric Assessment
Quality of Life
11-164
Fallopian Tubes

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on September 18, 2014