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

Indiana University Melvin and Bren Simon Cancer Center

Status and phase: Unknown; Phase 3

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Depression; Pain

Treatments: Procedure: psychosocial assessment and care; Procedure: pain therapy; Procedure: management of therapy complications; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00313573

CDR0000466348

IUMC-051009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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