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

19 septembre 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

480

Phase

Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Répartition: Randomisé

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
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

Mesures de résultats secondaires

Mesure des résultats
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Indiana University Melvin and Bren Simon Cancer Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

Chaise d'étude: Kurt Kroenke, MD, Regenstrief Institute, Incorporated

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2006

Achèvement primaire (Anticipé)

1 janvier 2010

Dates d'inscription aux études

Première soumission

11 avril 2006

Première soumission répondant aux critères de contrôle qualité