Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes

NCT ID: NCT00300001

Last Updated: 2006-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Solid Tumor Hematologic Malignancy

Keywords

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Cancer Symptom Management Supportive Symptom Interventions Symptom Severity quality of life Home-based symptom monitoring

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Community Cancer Care

OTHER

Sponsor Role lead

Principal Investigators

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Dale E. Theobald, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Community Cancer Care, Inc.

Locations

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Quality Oncology Care, Inc.

Indianapolis, Indiana, United States

Site Status RECRUITING

Community Regional Cancer Center-Community Hospital North

Indianapolis, Indiana, United States

Site Status RECRUITING

Morgan Hospital and Medical Center

Martinsville, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dale E Theobald, PhD, MD

Role: CONTACT

Phone: 317-621-4325

Email: [email protected]

Donna L Butler, MSN

Role: CONTACT

Phone: 317-621-4305

Email: [email protected]

References

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Berger AM, Portenoy RK, Weissman DE., Eds. Principles and Practice of Supportive Oncology, 2nd Ed.; Lippincott-Raven: Philadelphia, 2002.

Reference Type BACKGROUND

Max MB, Portenoy RK, Laska EM, Eds. Oxford Textbook of Palliative Medicine, 2nd Ed.; Oxford Medical Publications: New York, 1998.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12380956 (View on PubMed)

Chang VT, Ingham J. Symptom control. Cancer Invest. 2003;21(4):564-78. doi: 10.1081/cnv-120022376.

Reference Type BACKGROUND
PMID: 14533447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12902440 (View on PubMed)

Oncology Nursing Society, Research Agenda, 2003-2205. Available at http://www.ons.org/images/PDFs/Research/2003Plan.pdf.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9552071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10214600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15717933 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15108222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11013380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1568168 (View on PubMed)

Kreuger RA. Focus Groups: A practical guide for Applied Research. Sage Publications: Thousand Oakes, CA, 1994.

Reference Type BACKGROUND

Munhall P. Nursing Research: A qualitative perspective, third edition. 2001.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 8445433 (View on PubMed)

Morgan, D. Focus Groups as Qualitative Research. Sage Publications. Thousand Oakes, CA, 1997.

Reference Type BACKGROUND

Other Identifiers

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2005-0186

Identifier Type: -

Identifier Source: org_study_id