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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.

調査の概要

状態

わからない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

480

段階

フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

割り当て：ランダム化

この研究は何を測定していますか？

主要な結果の測定

結果測定
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

二次結果の測定

結果測定
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Indiana University Melvin and Bren Simon Cancer Center

協力者

National Cancer Institute (NCI)

捜査官

スタディチェア：Kurt Kroenke, MD、Regenstrief Institute, Incorporated

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2006年2月1日

一次修了 (予想される)

2010年1月1日

試験登録日

最初に提出

2006年4月11日

QC基準を満たした最初の提出物