NCT00580476

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
16.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

18 years

First QC Date

December 19, 2007

Last Update Submit

September 6, 2024

Conditions

Keywords

Breast CancerProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (1)

  • To develop a cut-off score for the GDS that is specific to a cancer population.

    2 years

Study Arms (2)

1

150 patients will be women with breast cancer (75 early stage and 75 late stage)

2

150 will be men with prostate cancer (75 early stage and 75 late stage)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Geriatric Patients with Breast or Prostate Cancer

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Christian Nelson, Ph.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 24, 2007

Study Start

September 12, 2006

Primary Completion

September 5, 2024

Study Completion

September 5, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations