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

19. september 2013 oppdatert 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Forventet)

480

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Tildeling: Randomisert

Hva måler studien?

Primære resultatmål

Resultatmål
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

Sekundære resultatmål

Resultatmål
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Indiana University Melvin and Bren Simon Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Kurt Kroenke, MD, Regenstrief Institute, Incorporated

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2006

Primær fullføring (Forventet)

1. januar 2010

Datoer for studieregistrering

Først innsendt

11. april 2006

Først innsendt som oppfylte QC-kriteriene