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

19 september 2013 bijgewerkt door: Indiana University Melvin and Bren Simon Cancer Center

TeleCare Management of Pain and Depression in 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

480

Fase

Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Indiana
  - Anderson, Indiana, Verenigde Staten, 46011
    - Community Cancer Center at Community Hospital of Anderson
  - Bedford, Indiana, Verenigde Staten, 47421
    - Community Cancer Care at Bedford Oncology Specialty Clinic
  - Columbus, Indiana, Verenigde Staten, 47201
    - Columbus Regional Hospital Cancer Center
  - Greencastle, Indiana, Verenigde Staten, 46135
    - Community Cancer Care at Putnam County Hospital
  - Greensburg, Indiana, Verenigde Staten, 47240
    - Community Cancer Care at Decatur County Hospital
  - Indianapolis, Indiana, Verenigde Staten, 46202
    - William N. Wishard Memorial Hospital
  - Indianapolis, Indiana, Verenigde Staten, 46206-1367
    - Methodist Cancer Center at Methodist Hospital
  - Indianapolis, Indiana, Verenigde Staten, 46219
    - Community Regional Cancer Care at Community Hospital East
  - Indianapolis, Indiana, Verenigde Staten, 46256
    - Community Regional Cancer Care at Community Hospital North
  - Indianapolis, Indiana, Verenigde Staten, 46202
    - Veterans Affairs Medical Center - Indianapolis
  - Indianapolis, Indiana, Verenigde Staten, 46202-2872
    - Regenstrief Institute, Incorporated
  - Indianapolis, Indiana, Verenigde Staten, 46202
    - Community Cancer Care
  - Kokomo, Indiana, Verenigde Staten, 46902
    - Community Cancer Care at Howard Regional Health System
  - Madison, Indiana, Verenigde Staten, 47250
    - Community Cancer Care at King's Daughters' Hospital
  - Seymour, Indiana, Verenigde Staten, 47274
    - Schneck Medical Center
  - Tell City, Indiana, Verenigde Staten, 47586
    - Community Cancer Care at Perry County Hospital
  - Tipton, Indiana, Verenigde Staten, 46072
    - Community Cancer Care at Tipton County Memorial Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Toewijzing: Gerandomiseerd

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
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

Secundaire uitkomstmaten

Uitkomstmaat
Health-related quality of life at baseline and 1, 3, 6, and 12 months
Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months
Treatment satisfaction at baseline and 1, 3, 6, and 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Indiana University Melvin and Bren Simon Cancer Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

Studie stoel: Kurt Kroenke, MD, Regenstrief Institute, Incorporated

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2006

Primaire voltooiing (Verwacht)

1 januari 2010

Studieregistratiedata

Eerst ingediend

11 april 2006

Eerst ingediend dat voldeed aan de QC-criteria