- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00300001
Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dale E Theobald, PhD, MD
- Numéro de téléphone: 317-621-4325
- E-mail: dtheobald@ecommunity.com
Sauvegarde des contacts de l'étude
- Nom: Donna L Butler, MSN
- Numéro de téléphone: 317-621-4305
- E-mail: dbutler@ecommunity.com
Lieux d'étude
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46202
- Recrutement
- Quality Oncology Care, Inc.
-
Chercheur principal:
- Dale E Theobald, PhD, MD
-
Indianapolis, Indiana, États-Unis, 46256
- Recrutement
- Community Regional Cancer Center-Community Hospital North
-
Chercheur principal:
- Dale E Theobald, PhD, MD
-
Martinsville, Indiana, États-Unis, 46151
- Recrutement
- Morgan Hospital and Medical Center
-
Chercheur principal:
- Dale E. Theobald, PhD, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
18 years old or older Diagnosis of solid tumor or hematologic malignancy Starting active treatment (chemotherapy or hormonal therapy) Must be able to give informed consent & consent to use the Cancer Symptom Monitor -
Exclusion Criteria:
Inability to give informed consent Life expectancy of less than 3 months Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Dale E. Theobald, PhD, MD, Community Cancer Care, Inc.
Publications et liens utiles
Publications générales
- Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.
- Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
- McDonald MV, Passik SD, Dugan W, Rosenfeld B, Theobald DE, Edgerton S. Nurses' recognition of depression in their patients with cancer. Oncol Nurs Forum. 1999 Apr;26(3):593-9.
- Patrick DL, Ferketich SL, Frame PS, Harris JJ, Hendricks CB, Levin B, Link MP, Lustig C, McLaughlin J, Ried LD, Turrisi AT 3rd, Unutzer J, Vernon SW; National Institutes of Health State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference Statement: Symptom Management in Cancer: Pain, Depression, and Fatigue, July 15-17, 2002. J Natl Cancer Inst. 2003 Aug 6;95(15):1110-7. doi: 10.1093/jnci/djg014.
- Berger AM, Portenoy RK, Weissman DE., Eds. Principles and Practice of Supportive Oncology, 2nd Ed.; Lippincott-Raven: Philadelphia, 2002.
- Max MB, Portenoy RK, Laska EM, Eds. Oxford Textbook of Palliative Medicine, 2nd Ed.; Oxford Medical Publications: New York, 1998.
- Cleeland CS, Reyes-Gibby CC. When is it justified to treat symptoms? Measuring symptom burden. Oncology (Williston Park). 2002 Sep;16(9 Suppl 10):64-70.
- Chang VT, Ingham J. Symptom control. Cancer Invest. 2003;21(4):564-78. doi: 10.1081/cnv-120022376.
- Oncology Nursing Society, Research Agenda, 2003-2205. Available at http://www.ons.org/images/PDFs/Research/2003Plan.pdf.
- Passik SD, Dugan W, McDonald MV, Rosenfeld B, Theobald DE, Edgerton S. Oncologists' recognition of depression in their patients with cancer. J Clin Oncol. 1998 Apr;16(4):1594-600. doi: 10.1200/JCO.1998.16.4.1594.
- Abdullah M, Theobald DE, Butler D, Kroenke K, Perkins A, Edgerton S, Dugan WM Jr. Access to communication technologies in a sample of cancer patients: an urban and rural survey. BMC Cancer. 2005 Feb 17;5:18. doi: 10.1186/1471-2407-5-18.
- Theobald DE, Butler D, Coburn J, et al. IVR-based cancer symptom assessment: Nurses' expectations and perceived barriers. (Abstract) Am Soc Clin Oncol, New Orleans, 2004.
- Schubert MM, Williams BE, Lloid ME, Donaldson G, Chapko MK. Clinical assessment scale for the rating of oral mucosal changes associated with bone marrow transplantation. Development of an oral mucositis index. Cancer. 1992 May 15;69(10):2469-77. doi: 10.1002/1097-0142(19920515)69:103.0.co;2-w.
- Kreuger RA. Focus Groups: A practical guide for Applied Research. Sage Publications: Thousand Oakes, CA, 1994.
- Munhall P. Nursing Research: A qualitative perspective, third edition. 2001.
- Morgan, D. Focus Groups as Qualitative Research. Sage Publications. Thousand Oakes, CA, 1997.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2005-0186
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .