Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes
23. august 2006 opdateret af: Community Cancer Care
The primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Patients will be randomly assigned to one of two groups.
One group will be offered an Internet assisted home-based symptom reporting system Cancer Symptom Monitor (CSM) for a twelve-month study period.
Patient and care team evaluations will be measured using quantitative and qualitative methods (via focus groups).
The second group will receive "standard care" without home-based symptom monitoring.
Both groups will be evaluated at baseline, 1, 2, 3, 6, 9, & 12 months, for symptom levels and overall quality of life during the twelve-month study period.
Undersøgelsestype
Observationel
Tilmelding
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Quality Oncology Care, Inc.
-
Ledende efterforsker:
- Dale E Theobald, PhD, MD
-
Indianapolis, Indiana, Forenede Stater, 46256
- Rekruttering
- Community Regional Cancer Center-Community Hospital North
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Ledende efterforsker:
- Dale E Theobald, PhD, MD
-
Martinsville, Indiana, Forenede Stater, 46151
- Rekruttering
- Morgan Hospital and Medical Center
-
Ledende efterforsker:
- Dale E. Theobald, PhD, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dale E. Theobald, PhD, MD, Community Cancer Care, Inc.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2006
Datoer for studieregistrering
Først indsendt
3. marts 2006
Først indsendt, der opfyldte QC-kriterier
3. marts 2006
Først opslået (Skøn)
7. marts 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. august 2006
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. august 2006
Sidst verificeret
1. august 2006
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2005-0186
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .