Breast CancerNCT00580476
Assessing Depression in a Geriatric Cancer Population
An observational study of Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2006to 5 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric Patients with Breast or Prostate Cancer
Who may be able to join
- 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
Who cannot join
- 1.Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read the 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:
- 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.
- Answer questions about your mood. This will also take about 10 minutes to complete.
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- Breast Cancer, Prostate Cancer
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
To develop a cut-off score for the GDS that is specific to a cancer population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start12 Sep 2006
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope National Medical Center
- Responsible party
- Sponsor
- Investigators
- Christian Nelson, Ph.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580476
- Sponsor's protocol ID
- 06-100
- Status last verified
- Sep 2024
- First submitted
- 19 Dec 2007
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Depression in a Geriatric Cancer Population
- ClinicalTrials.gov ID
- NCT00580476
- Acronym / sponsor ID
- 06-100
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- Breast Cancer, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- City of Hope National Medical Center
- Study start
- 12 Sep 2006 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Answer questions about your mood. This will also take about 10 minutes to complete.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric Patients with Breast or Prostate Cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 1.Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To develop a cut-off score for the GDS that is specific to a cancer population.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Nelson, Ph.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.