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