Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer
2013년 9월 19일 업데이트: 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.
연구 개요
상태
알려지지 않은
상세 설명
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.
연구 유형
중재적
등록 (예상)
480
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Indiana
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Anderson, Indiana, 미국, 46011
- Community Cancer Center at Community Hospital of Anderson
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Bedford, Indiana, 미국, 47421
- Community Cancer Care at Bedford Oncology Specialty Clinic
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Columbus, Indiana, 미국, 47201
- Columbus Regional Hospital Cancer Center
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Greencastle, Indiana, 미국, 46135
- Community Cancer Care at Putnam County Hospital
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Greensburg, Indiana, 미국, 47240
- Community Cancer Care at Decatur County Hospital
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Indianapolis, Indiana, 미국, 46202
- William N. Wishard Memorial Hospital
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Indianapolis, Indiana, 미국, 46206-1367
- Methodist Cancer Center at Methodist Hospital
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Indianapolis, Indiana, 미국, 46219
- Community Regional Cancer Care at Community Hospital East
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Indianapolis, Indiana, 미국, 46256
- Community Regional Cancer Care at Community Hospital North
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Indianapolis, Indiana, 미국, 46202
- Veterans Affairs Medical Center - Indianapolis
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Indianapolis, Indiana, 미국, 46202-2872
- Regenstrief Institute, Incorporated
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Indianapolis, Indiana, 미국, 46202
- Community Cancer Care
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Kokomo, Indiana, 미국, 46902
- Community Cancer Care at Howard Regional Health System
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Madison, Indiana, 미국, 47250
- Community Cancer Care at King's Daughters' Hospital
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Seymour, Indiana, 미국, 47274
- Schneck Medical Center
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Tell City, Indiana, 미국, 47586
- Community Cancer Care at Perry County Hospital
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Tipton, Indiana, 미국, 46072
- Community Cancer Care at Tipton County Memorial Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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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
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2차 결과 측정
결과 측정 |
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Health-related quality of life at baseline and 1, 3, 6, and 12 months
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Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months
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Treatment satisfaction at baseline and 1, 3, 6, and 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Kurt Kroenke, MD, Regenstrief Institute, Incorporated
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu.
- Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.
- Brown LF, Kroenke K, Theobald DE, Wu J, Tu W. The association of depression and anxiety with health-related quality of life in cancer patients with depression and/or pain. Psychooncology. 2010 Jul;19(7):734-41. doi: 10.1002/pon.1627.
- Kroenke K, Theobald D, Wu J, Norton K, Morrison G, Carpenter J, Tu W. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010 Jul 14;304(2):163-71. doi: 10.1001/jama.2010.944.
- Kroenke K, Zhong X, Theobald D, Wu J, Tu W, Carpenter JS. Somatic symptoms in patients with cancer experiencing pain or depression: prevalence, disability, and health care use. Arch Intern Med. 2010 Oct 11;170(18):1686-94. doi: 10.1001/archinternmed.2010.337.
- Cohee AA, Kroenke K, Vachon E, Wu J, Tu W, Johns SA. Predictors of depression outcomes in adults with cancer: A 12 month longitudinal study. J Psychosom Res. 2020 Sep;136:110169. doi: 10.1016/j.jpsychores.2020.110169. Epub 2020 Jun 11.
- Choi Yoo SJ, Nyman JA, Cheville AL, Kroenke K. Cost effectiveness of telecare management for pain and depression in patients with cancer: results from a randomized trial. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):599-606. doi: 10.1016/j.genhosppsych.2014.07.004. Epub 2014 Jul 19.
- Hayano J, Carney RM, Watanabe E, Kawai K, Kodama I, Stein PK, Watkins LL, Freedland KE, Blumenthal JA. Interactive associations of depression and sleep apnea with adverse clinical outcomes after acute myocardial infarction. Psychosom Med. 2012 Oct;74(8):832-9. doi: 10.1097/PSY.0b013e31826d2c81. Epub 2012 Sep 28.
- Wang HL, Kroenke K, Wu J, Tu W, Theobald D, Rawl SM. Predictors of cancer-related pain improvement over time. Psychosom Med. 2012 Jul-Aug;74(6):642-7. doi: 10.1097/PSY.0b013e3182590904. Epub 2012 Jun 28.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 2월 1일
기본 완료 (예상)
2010년 1월 1일
연구 등록 날짜
최초 제출
2006년 4월 11일
QC 기준을 충족하는 최초 제출
2006년 4월 11일
처음 게시됨 (추정)
2006년 4월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 9월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 9월 19일
마지막으로 확인됨
2009년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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