Ovarian CancerPhase 1NCT00515372
Depression Treatment and Screening in Ovarian Cancer Patients
A Phase 1 study testing Telephone Counseling in people with Ovarian Cancer and Peritoneal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of this study is to compare an intervention program with "enhanced" standard care to see which may be more effective in improving quality… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Telephone Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2002to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women are eligible if they a) are on active treatment, but not at the end of a treatment regimen) for newly diagnosed, recurrent, or persistent ovarian cancer or peritoneal cancer or fallopian tube cancer (any stage) c) are at least 18 years of age; d) speak and read English at a 7th grade level; e) are oriented to time, person, and place; g) have a Zubrod performance status (49) of 0-2; and h) provide informed consent.
- They are eligible for the pilot intervention phase of the study if they have a diagnosis of major depressive disorder, dysthymic disorder, adjustment disorder with depressed mood, minor depression, major depression in partial remission, or recurrent brief depressive disorder.
Who cannot join
- 1) They will be excluded from this phase of the study if they are diagnosed as having a bipolar disorder or psychosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of this study is to compare an intervention program with "enhanced" standard care to see which may be more effective in improving quality of life for these patients.
Read the detailed description
Study Participation:
If you agree to take part in this study, you will fill out a questionnaire, complete an interview (called a SCID interview), and information will be collected from your medical record.
For the questionnaire, you will answer questions about your mood, ability to cope with cancer, thoughts about cancer, and demographic information (such as your age and race). It should take between 30 and 40 minutes to complete the questionnaire.
For the SCID interview (which may be conducted during your routine visit at M. D. Anderson or by telephone), a trained interviewer will ask you questions related to the degree of depression you may be experiencing. It should take between 30 and 40 minutes to complete the SCID interview. The study staff will also show you TAT cards, which are standardized psychological testing cards, and ask you to give responses to the cards.
Information collected from your medical record will include the cancer stage, if the disease has gotten worse, treatment, and side effects. This information will help researchers learn how specific treatments affect patients.
- You may also be asked to have an informal interview on your personal experience about matters not related to depression. Information learned from this interview may need to be addressed in order to help you cope with your personal cancer experiences (such as communicating with your study doctor and study staff, financial counseling, and spiritual guidance).
- If you are not found to be eligible for the intervention group, you will be contacted again in 4 months to complete a second questionnaire and SCID interview. Both will be the same as the first questionnaire and SCID interview, except that the questionnaire will have additional questions about the type of psychosocial help you may have received outside of this research study during the 4-month period.
Study Group Randomization:
If your answers to the first questionnaire show that you might benefit from psychosocial support, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups (an intervention group or an enhanced standard care group).
Intervention Group:
If you are assigned to the intervention group, you will receive intervention plus enhanced standard care that is described below. For the intervention, you will have 10 telephone calls by a trained psychologist under the supervision of a licensed psychiatrist. The psychologist will discuss with you and teach you cognitive-behavioral techniques. These techniques will show you ways to relax, how to schedule physical activities, and how to identify and counter negative thoughts. You will also receive a journal to write down ideas on how to practice fighting depression. These intervention calls will last about 30 minutes each time, and will occur once a week (almost every week).
Standard Care Group:
If you are assigned to the enhanced standard care group, you will be informed of the results of the analysis of your first questionnaire and provided with a list of professional resources and referral recommendations for psychosocial counseling. Your treating doctor and/or regular doctor will also be informed of these results as well. After 4 months in this group, you will be able to receive the intervention as described above.
Additional Information:
In order to check for quality control (to see if the intervention and SCID interview have been appropriately done), a random sample of telephone counseling sessions (from the intervention group) will be tape recorded, and a random sample of interviews (the SCID interviews) will be tape recorded and/or videotaped. Before any information is tape recorded and/or videotaped, you will be asked for your permission.
The tape recording and/or videotaping will be done by members of study staff. No identifying information (such as your name and medical record number) will be recorded on the audiotape and/or videotape. The audiotape and/or videotape will only be labeled with study ID numbers.
Length of Study:
If your answers to the first questionnaire do not show that you might benefit from psychosocial support, your participation will be over (in about 4 months) after you have completed the follow-up questionnaire and SCID interview.
If you are assigned to the intervention, your participation will be over (in about 4 months) once you have completed the 10 weekly intervention sessions.
If you are assigned to the standard care group, your participation will be over in about 4 months, or about 8 months if you are able to also take part in the intervention once you have completed your participation in the standard care group.
This is an investigational study. Up to 588 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- Telephone Counseling, Usual Care
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Depression, Telephone Counseling, Quality of Life
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CounselingOther
Also called Survey
Weekly phone calls lasting about 30 minutes.
Usual CareOther
Lists of professional resources and referral recommendations will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided. Receives: Other: Telephone Counseling |
| Usual Care Group | Other | Lists of professional resources and referral recommendations will be provided. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Responses to Questionnaire Assessment of Depression Measures
Measured: Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study start20 Dec 2002
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lance Armstrong Foundation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eileen H. Shinn, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515372
- Sponsor's protocol ID
- ID02-258
- Other IDs
- NCI-2012-02127, 1CF2002-0000832 HM 01, K07CA093512-01A2
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2007
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Treatment and Screening in Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT00515372
- Acronym / sponsor ID
- ID02-258
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Depression, Telephone Counseling, Quality of Life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 409 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Lance Armstrong Foundation, National Cancer Institute (NCI)
- Study start
- 20 Dec 2002 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Aug 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 behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of this study is to compare an intervention program with "enhanced" standard care to see which may be more effective in improving quality of life for these patients.
Detailed description
Study Participation:
If you agree to take part in this study, you will fill out a questionnaire, complete an interview (called a SCID interview), and information will be collected from your medical record.
For the questionnaire, you will answer questions about your mood, ability to cope with cancer, thoughts about cancer, and demographic information (such as your age and race). It should take between 30 and 40 minutes to complete the questionnaire.
For the SCID interview (which may be conducted during your routine visit at M. D. Anderson or by telephone), a trained interviewer will ask you questions related to the degree of depression you may be experiencing. It should take between 30 and 40 minutes to complete the SCID interview. The study staff will also show you TAT cards, which are standardized psychological testing cards, and ask you to give responses to the cards.
Information collected from your medical record will include the cancer stage, if the disease has gotten worse, treatment, and side effects. This information will help researchers learn how specific treatments affect patients.
- You may also be asked to have an informal interview on your personal experience about matters not related to depression. Information learned from this interview may need to be addressed in order to help you cope with your personal cancer experiences (such as communicating with your study doctor and study staff, financial counseling, and spiritual guidance).
- If you are not found to be eligible for the intervention group, you will be contacted again in 4 months to complete a second questionnaire and SCID interview. Both will be the same as the first questionnaire and SCID interview, except that the questionnaire will have additional questions about the type of psychosocial help you may have received outside of this research study during the 4-month period.
Study Group Randomization:
If your answers to the first questionnaire show that you might benefit from psychosocial support, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups (an intervention group or an enhanced standard care group).
Intervention Group:
If you are assigned to the intervention group, you will receive intervention plus enhanced standard care that is described below. For the intervention, you will have 10 telephone calls by a trained psychologist under the supervision of a licensed psychiatrist. The psychologist will discuss with you and teach you cognitive-behavioral techniques. These techniques will show you ways to relax, how to schedule physical activities, and how to identify and counter negative thoughts. You will also receive a journal to write down ideas on how to practice fighting depression. These intervention calls will last about 30 minutes each time, and will occur once a week (almost every week).
Standard Care Group:
If you are assigned to the enhanced standard care group, you will be informed of the results of the analysis of your first questionnaire and provided with a list of professional resources and referral recommendations for psychosocial counseling. Your treating doctor and/or regular doctor will also be informed of these results as well. After 4 months in this group, you will be able to receive the intervention as described above.
Additional Information:
In order to check for quality control (to see if the intervention and SCID interview have been appropriately done), a random sample of telephone counseling sessions (from the intervention group) will be tape recorded, and a random sample of interviews (the SCID interviews) will be tape recorded and/or videotaped. Before any information is tape recorded and/or videotaped, you will be asked for your permission.
The tape recording and/or videotaping will be done by members of study staff. No identifying information (such as your name and medical record number) will be recorded on the audiotape and/or videotape. The audiotape and/or videotape will only be labeled with study ID numbers.
Length of Study:
If your answers to the first questionnaire do not show that you might benefit from psychosocial support, your participation will be over (in about 4 months) after you have completed the follow-up questionnaire and SCID interview.
If you are assigned to the intervention, your participation will be over (in about 4 months) once you have completed the 10 weekly intervention sessions.
If you are assigned to the standard care group, your participation will be over in about 4 months, or about 8 months if you are able to also take part in the intervention once you have completed your participation in the standard care group.
This is an investigational study. Up to 588 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Telephone CounselingWeekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided. |
| Usual Care Group | Other | Other: Usual CareLists of professional resources and referral recommendations will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women are eligible if they a) are on active treatment, but not at the end of a treatment regimen) for newly diagnosed, recurrent, or persistent ovarian cancer or peritoneal cancer or fallopian tube cancer (any stage) c) are at least 18 years of age; d) speak and read English at a 7th grade level; e) are oriented to time, person, and place; g) have a Zubrod performance status (49) of 0-2; and h) provide informed consent.
- They are eligible for the pilot intervention phase of the study if they have a diagnosis of major depressive disorder, dysthymic disorder, adjustment disorder with depressed mood, minor depression, major depression in partial remission, or recurrent brief depressive disorder.
Key exclusion criteria (1 listed)
- 1) They will be excluded from this phase of the study if they are diagnosed as having a bipolar disorder or psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone CounselingAlso: SurveyWeekly phone calls lasting about 30 minutes. | Other | Intervention Group |
| Usual CareLists of professional resources and referral recommendations will be provided. | Other | Usual Care Group |
Primary outcome
Patient Responses to Questionnaire Assessment of Depression Measures
Time frame: Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Eileen H. Shinn, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telephone Counseling in people with Ovarian Cancer and Peritoneal Cancer, run by M.D. Anderson 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 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Patient Responses to Questionnaire Assessment of Depression Measures (time frame: Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.). 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 18 Sep 2026.