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

Depression Clinical Trial

Official title:

TeleCare Management of Pain and Depression in Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00313573
• Other study ID #: CDR0000466348
• Secondary ID: IUMC-051009
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: September 19, 2013
• Start date: February 2006

Study information

• Verified date: May 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• management of therapy complications

• pain therapy

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Community Cancer Center at Community Hospital of Anderson	Anderson	Indiana
United States	Community Cancer Care at Bedford Oncology Specialty Clinic	Bedford	Indiana
United States	Columbus Regional Hospital Cancer Center	Columbus	Indiana
United States	Community Cancer Care at Putnam County Hospital	Greencastle	Indiana
United States	Community Cancer Care at Decatur County Hospital	Greensburg	Indiana
United States	Community Cancer Care	Indianapolis	Indiana
United States	Community Regional Cancer Care at Community Hospital East	Indianapolis	Indiana
United States	Community Regional Cancer Care at Community Hospital North	Indianapolis	Indiana
United States	Methodist Cancer Center at Methodist Hospital	Indianapolis	Indiana
United States	Regenstrief Institute, Incorporated	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis	Indianapolis	Indiana
United States	William N. Wishard Memorial Hospital	Indianapolis	Indiana
United States	Community Cancer Care at Howard Regional Health System	Kokomo	Indiana
United States	Community Cancer Care at King's Daughters' Hospital	Madison	Indiana
United States	Schneck Medical Center	Seymour	Indiana
United States	Community Cancer Care at Perry County Hospital	Tell City	Indiana
United States	Community Cancer Care at Tipton County Memorial Hospital	Tipton	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University Melvin and Bren Simon Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	Health-related quality of life at baseline and 1, 3, 6, and 12 months			No
Secondary	Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months			No
Secondary	Treatment satisfaction at baseline and 1, 3, 6, and 12 months			No