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Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer

2013年9月19日更新者：Indiana University Melvin and Bren Simon Cancer Center

TeleCare Management of Pain and Depression in Cancer

RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.

PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.

研究概览

地位

未知

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

Compare the effectiveness of a state-wide, telemedicine intervention with standard care in cancer patients with clinical depression and/or cancer-related pain.
Compare improvement in clinical depression and/or cancer-related pain in patients undergoing these interventions.

Secondary

Compare health-related quality of life, functional status, and patient satisfaction with treatment in patients undergoing these interventions.
Compare the economic benefits of these interventions in these patients.

OUTLINE: This is a randomized, longitudinal, multicenter study. Patients are stratified according to study site and type of symptom (pain only vs depression only vs pain and depression). Patients are randomized to 1 of 2 treatment arms.

Arm I (standard care): Patients receive treatment for pain, depression, and other symptoms from their oncologist.
Arm II (telemedicine intervention): Patients undergo automated, home-based symptom monitoring either by telephone or the Internet, depending on preference, coupled with telephonic care management by a clinical specialist. Patients complete questionnaires via the Internet or undergo standardized interviews via telephone measuring depression, pain, quality of life, and other patient-reported variables twice weekly for approximately 1 month, once weekly for 2 months, twice a month for 3 months, and then once a month for 6 months. A clinical specialist trained in treating the symptoms of pain and depression also contacts the patient by phone to assess symptom severity and initiate treatment. A follow-up call is made at 1-2 weeks to assess symptom severity, adherence, and adverse effects. Patients with depression receive 2 additional follow-up calls in the first 12 weeks. The clinical specialist also calls the patient when automated monitoring indicates inadequate symptom improvement or side effects, or the patient requests to be contacted. The clinical specialist works with the patient's regular doctor in adjusting medicines and treatment for symptoms as needed. Patients who do not complete their scheduled assessments receive an automated call or e-mail message reminding them to complete the symptoms questionnaires. Patients who do not respond to this reminder within 24 hours are contacted by the clinical specialist.

In both arms, patients are interviewed at baseline, 1, 3, 6, and 12 months. Patients are asked questions about pain, depression, other physical and emotional symptoms, work activities, quality of life, and satisfaction with treatment.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.

研究类型

介入性

注册 (预期的)

480

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Indiana
  - Anderson、Indiana、美国、46011
    - Community Cancer Center at Community Hospital of Anderson
  - Bedford、Indiana、美国、47421
    - Community Cancer Care at Bedford Oncology Specialty Clinic
  - Columbus、Indiana、美国、47201
    - Columbus Regional Hospital Cancer Center
  - Greencastle、Indiana、美国、46135
    - Community Cancer Care at Putnam County Hospital
  - Greensburg、Indiana、美国、47240
    - Community Cancer Care at Decatur County Hospital
  - Indianapolis、Indiana、美国、46202
    - William N. Wishard Memorial Hospital
  - Indianapolis、Indiana、美国、46206-1367
    - Methodist Cancer Center at Methodist Hospital
  - Indianapolis、Indiana、美国、46219
    - Community Regional Cancer Care at Community Hospital East
  - Indianapolis、Indiana、美国、46256
    - Community Regional Cancer Care at Community Hospital North
  - Indianapolis、Indiana、美国、46202
    - Veterans Affairs Medical Center - Indianapolis
  - Indianapolis、Indiana、美国、46202-2872
    - Regenstrief Institute, Incorporated
  - Indianapolis、Indiana、美国、46202
    - Community Cancer Care
  - Kokomo、Indiana、美国、46902
    - Community Cancer Care at Howard Regional Health System
  - Madison、Indiana、美国、47250
    - Community Cancer Care at King's Daughters' Hospital
  - Seymour、Indiana、美国、47274
    - Schneck Medical Center
  - Tell City、Indiana、美国、47586
    - Community Cancer Care at Perry County Hospital
  - Tipton、Indiana、美国、46072
    - Community Cancer Care at Tipton County Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

Diagnosis of cancer AND 1 or both of the following:
- Clinical depression
  - Depression must be of at least moderate severity (PHQ-9 score ≥ 10)
    - Depressed mood and/or anhedonia endorsed
  - No depression directly precipitated by cancer therapy for which depression is a well known side effect (e.g., interferon, corticosteroids)
- Cancer-related pain
  - Pain must be at least moderate in severity (Brief Pain Inventory score ≥ 6), persisted despite using ≥ 2 analgesics, and cancer-related
  - If the only pain is due to a pre-existing condition (e.g., migraine, headache, arthritis, etc), the patient may not be eligible

PATIENT CHARACTERISTICS:

Life expectancy ≥ 6 months
Must speak English
Not pregnant
Fertile patients must use effective contraception
No moderately severe cognitive impairment
No schizophrenia or other psychosis
No disability claim currently being adjudicated for pain

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Not in hospice care

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

分配：随机化

研究衡量的是什么？

主要结果指标

结果测量
Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

次要结果测量

结果测量
Health-related quality of life at baseline and 1, 3, 6, and 12 months
Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months
Treatment satisfaction at baseline and 1, 3, 6, and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Indiana University Melvin and Bren Simon Cancer Center

合作者

National Cancer Institute (NCI)

调查人员

学习椅：Kurt Kroenke, MD、Regenstrief Institute, Incorporated

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年2月1日

初级完成 (预期的)

2010年1月1日

研究注册日期

首次提交

2006年4月11日

首先提交符合 QC 标准的