跳至主要内容
临床试验/NCT00498875
NCT00498875进行中(未招募)不适用

Depression and Adherence in Head and Neck Cancer

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2005年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
185
试验地点
1
主要终点
Recruitment rate, Patient satisfaction, Attendance, Questionnaire Completion Rates (questionnaire responses)

研究概览

简要总结

Primary Objectives:

  • Develop and pilot test an innovative intervention to determine its feasibility and acceptability to patients. Recruitment rate, patient satisfaction, attendance, questionnaire completion rates and the reliability and validity of the questionnaires will be assessed.
  • Conduct preliminary analyses on the efficacy of the intervention in improving patients' depression. Evaluate whether depression levels in patients receiving the intervention decreases, and whether the decrease is greater among those who complete more sessions.
  • Test the relationship between patients' depression levels and adherence to swallowing rehabilitation and to dental preventive maintenance regimens.

详细描述

You will be asked to fill out a questionnaire containing questions about your mood, coping with cancer, how closely you follow your treatment schedule, your thoughts, your demographic information (such as age and race), and your medical history. It should take between 25-35 minutes to complete the questionnaire. If you score as nondepressed on the questionnaire, you will be contacted again every week for 6 weeks during radiation treatment, to check for depression again. If you score as depressed during a later screening, you will then be asked additional questions about your symptoms, coping, and social support. It should take between 10-20 minutes to complete these additional questions.

If the answers to your questionnaire indicate that you may be depressed, you will be offered the intervention portion of the study. Only those participants who score as depressed on the questionnaire will be assigned to the intervention. You will then be informed of your test results, and provided with a list of community referrals. Whoever is responsible for your treatment, whether he or she is a M.D. Anderson physician, community referring physician, or both, will also be informed of these test results, and a note will be added to your medical record.

You will be asked to take part in 7 sessions with a trained doctoral-level psychologist or advanced clinical doctoral student under the supervision of a licensed psychiatrist. The first two sessions may be conducted in person, face to face, or may be conducted over the telephone. The remaining five sessions will be done over the telephone. These sessions will last between 30 and 45 minutes and will occur every week for seven weeks.

The 30-45 minute telephone sessions will use "cognitive-behavioral" techniques, a method proven to be effective in relieving depressive symptoms. Cognitive-behavioral techniques will teach you skills in relaxation and activity scheduling, as well as ways to recognize and fight negative thoughts. You will also be given a journal to record and practice ways of fighting depression. The intervention will include an educational component for your spouse/partner or caregiver on the nature of clinical depression. The spouse/caregiver will be given a booklet which explains facts about depressive disorders and helpful ways that they can support you. You may also be given over-the counter samples of toothpaste and oral products if approved by your doctor or dentist. You will also be given the use of a mini-food-blender to help you problem solve issues of eating during the course of the study. You will be asked to return the mini-food-blender at the end of the study.

If you participate in the intervention, upon completion, you will receive a short survey asking about your satisfaction with the intervention. After completing the first questionnaire, you may be contacted again to complete five follow-up questionnaires, at the beginning of radiation treatment, as well as, six and twelve weeks and again, six and twelve months after radiation treatment begins. The questionnaires will be similar to the first one but will also contain questions about any additional depression care you received while participating in the study or after the intervention. This information will include prescription of antidepressants, formal referral to psychiatric services, referral to support groups, and any depression care you received in addition to the intervention in this study. You will also be asked how closely you followed the swallowing exercises, your dental care habits, and your referrals to other sources in the community.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • At least 18 years of age
  • Speak and read English at a 7th grade level
  • Are oriented to time, person, and place
  • Have a Zubrod performance status of 0-
  • To be eligible for the pilot depression intervention patients must score 9 or above on the Patient Health Questionnaire (PHQ-9). Additionally, if a patient has an elevated PHQ score and does not meet the cutoff but expresses a desire to be in the intervention in order to relieve his or her depression, then the PI will contact the participant to further assess eligibility for the intervention. Patients who do not make the cut-off will still be included in the study's statistical analyses.

排除标准

  • 1. Do not have other cancer diagnoses, excepting non-melanoma skin cancer.

研究组 & 干预措施

Questionnaire + Depression Intervention

干预措施: Questionnaire (Behavioral)

Questionnaire + Depression Intervention

干预措施: Depression Intervention (Behavioral)

结局指标

主要结局

Recruitment rate, Patient satisfaction, Attendance, Questionnaire Completion Rates (questionnaire responses)

时间窗: 5 Years

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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