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临床试验/NCT00515372
NCT00515372进行中(未招募)1 期

Depression Treatment and Screening in Ovarian Cancer Patients

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2002年12月20日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
409
试验地点
1
主要终点
Patient Responses to Questionnaire Assessment of Depression Measures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 1) They will be excluded from this phase of the study if they are diagnosed as having a bipolar disorder or psychosis.

研究组 & 干预措施

Intervention Group

Active Comparator

Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.

干预措施: Telephone Counseling (Other)

Usual Care Group

Other

Lists of professional resources and referral recommendations will be provided.

干预措施: Usual Care (Other)

结局指标

主要结局

Patient Responses to Questionnaire Assessment of Depression Measures

时间窗: Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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