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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00313573
First received: April 11, 2006
Last updated: September 19, 2013
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Depression
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: management of therapy complications
Procedure: pain therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: TeleCare Management of Pain and Depression in Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life at baseline and 1, 3, 6, and 12 months [ Designated as safety issue: No ]
  • Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months [ Designated as safety issue: No ]
  • Treatment satisfaction at baseline and 1, 3, 6, and 12 months [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: February 2006
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313573

Locations
United States, Indiana
Community Cancer Center at Community Hospital of Anderson
Anderson, Indiana, United States, 46011
Community Cancer Care at Bedford Oncology Specialty Clinic
Bedford, Indiana, United States, 47421
Columbus Regional Hospital Cancer Center
Columbus, Indiana, United States, 47201
Community Cancer Care at Putnam County Hospital
Greencastle, Indiana, United States, 46135
Community Cancer Care at Decatur County Hospital
Greensburg, Indiana, United States, 47240
Community Cancer Care
Indianapolis, Indiana, United States, 46202
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States, 46219
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
Regenstrief Institute, Incorporated
Indianapolis, Indiana, United States, 46202-2872
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States, 46256
Community Cancer Care at Howard Regional Health System
Kokomo, Indiana, United States, 46902
Community Cancer Care at King's Daughters' Hospital
Madison, Indiana, United States, 47250
Schneck Medical Center
Seymour, Indiana, United States, 47274
Community Cancer Care at Perry County Hospital
Tell City, Indiana, United States, 47586
Community Cancer Care at Tipton County Memorial Hospital
Tipton, Indiana, United States, 46072
Sponsors and Collaborators
Indiana University Melvin and Bren Simon Cancer Center
Investigators
Study Chair: Kurt Kroenke, MD Regenstrief Institute, Incorporated
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kurt Kroenke, Regenstrief Institute, Incorporated
ClinicalTrials.gov Identifier: NCT00313573     History of Changes
Other Study ID Numbers: CDR0000466348, IUMC-051009
Study First Received: April 11, 2006
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
pain
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014