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TeleCare Management of Pain and Depression in Cancer

Phase 3
18 Years
Open (Enrolling)
Depression, Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

TeleCare Management of Pain and Depression in Cancer



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

- Not in hospice care

Type of Study:


Study Design:

Allocation: Randomized

Outcome Measure:

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

Safety Issue:


Principal Investigator

Kurt Kroenke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Regenstrief Institute, Incorporated


United States: Federal Government

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Depression
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • pain
  • depression
  • Depression
  • Depressive Disorder



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