Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Assessing Depression in a Geriatric Cancer Population

This study is ongoing, but not recruiting participants.
City of Hope National Medical Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center. Identifier:
First received: December 19, 2007
Last updated: February 2, 2015
Last verified: February 2015

The goal of this study is to learn more about how we measure depression in elderly cancer patients (patients aged 70 and older). Depression is one of the most common causes of emotional distress in the elderly and continues to be under-recognized. This is a problem because depression can have a negative impact on quality of life. The symptoms of depression are linked to poor health outcomes and higher costs of health care. In fact, depression is one of the top five concerns facing the elderly today.

Breast Cancer
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessing Depression in a Geriatric Cancer Population

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Test the sensitivity and specificity of the Geriatric Depression Scale-Short Form and two other widely used assessments of depression to detect major and minor depression in a geriatric breast and prostate cancer population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To develop a cut-off score for the GDS that is specific to a cancer population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: September 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
150 patients will be women with breast cancer (75 early stage and 75 late stage)
150 will be men with prostate cancer (75 early stage and 75 late stage)

Detailed Description:

We have a few questionnaires that have been used to measure depression, but we do not know how these measures work with people with cancer. This study will help us answer this question. To complete this study, we need people who may or may not be feeling down or depressed.

If you choose to take part, you will be asked to do the following:

  1. Fill out questionnaires that ask about:

    • Your age, eduction, race, and income
    • Your mood

    In all, these questionnaires will take about 10 minutes to complete.

  2. Answer questions about your mood. This will also take about 10 minutes to complete.

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Geriatric Patients with Breast or Prostate Cancer


Inclusion Criteria:

  1. Age 70 and older
  2. Diagnosis of early or late stage prostate cancer, or diagnosis of early or late stage breast cancer
  3. Actively engaged in one of the following cancer treatments: chemotherapy, radiation therapy, hormone therapy
  4. Able to provide informed consent
  5. Ability to converse, write and read English

Exclusion Criteria:

1.Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.

  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 identifier: NCT00580476

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
City of Hope National Medical Center
Principal Investigator: Christian Nelson, Ph.D. Memorial Sloan Kettering Cancer Center.
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center. Identifier: NCT00580476     History of Changes
Other Study ID Numbers: 06-100
Study First Received: December 19, 2007
Last Updated: February 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:
Breast Cancer
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 27, 2015