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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02127 | Registry Identifier | NCI CTRP | |
| 1CF2002-0000832 HM 01 | Other Grant/Funding Number | Lance Armstrong Foundation | |
| K07CA093512-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Lance Armstrong Foundation | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided. |
|
| Usual Care Group | Other | Lists of professional resources and referral recommendations will be provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Counseling | Other | Weekly phone calls lasting about 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Responses to Questionnaire Assessment of Depression Measures | Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients. |
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Inclusion Criteria:
Exclusion Criteria:
1) They will be excluded from this phase of the study if they are diagnosed as having a bipolar disorder or psychosis.
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| Name | Affiliation | Role |
|---|---|---|
| Eileen H. Shinn, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D003863 | Depression |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Usual Care | Other | Lists of professional resources and referral recommendations will be provided. |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |