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

19 september 2013 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

480

Fas

Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Tilldelning: Randomiserad

Vad mäter studien?

Primära resultatmått

Resultatmått
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

Sekundära resultatmått

Resultatmått
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Indiana University Melvin and Bren Simon Cancer Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

Studiestol: Kurt Kroenke, MD, Regenstrief Institute, Incorporated

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2006

Primärt slutförande (Förväntat)

1 januari 2010

Studieregistreringsdatum

Först inskickad

11 april 2006

Först inskickad som uppfyllde QC-kriterierna