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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Pain Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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unspecified adult solid tumor, protocol specific pain depression

Study Design

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Allocation Method

RANDOMIZED

Interventions

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management of therapy complications

Intervention Type PROCEDURE

pain therapy

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Regenstrief Institute, Incorporated

Principal Investigators

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Kurt Kroenke, MD

Role: STUDY_CHAIR

Regenstrief Institute, Incorporated

Locations

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Community Cancer Center at Community Hospital of Anderson

Anderson, Indiana, United States

Site Status

Community Cancer Care at Bedford Oncology Specialty Clinic

Bedford, Indiana, United States

Site Status

Columbus Regional Hospital Cancer Center

Columbus, Indiana, United States

Site Status

Community Cancer Care at Putnam County Hospital

Greencastle, Indiana, United States

Site Status