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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00300001
• Other study ID #: 2005-0186
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2006
• Last updated: August 23, 2006
• Start date: March 2006

Study information

• Verified date: August 2006
• Source: Community Cancer Care
• Contact: Dale E Theobald, PhD, MD
• Phone: 317-621-4325
• Email: dtheobald[@]ecommunity.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Cancer
• Hematologic Malignancy
• Solid Tumor

Locations

Country	Name	City	State
United States	Community Regional Cancer Center-Community Hospital North	Indianapolis	Indiana
United States	Quality Oncology Care, Inc.	Indianapolis	Indiana
United States	Morgan Hospital and Medical Center	Martinsville	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Community Cancer Care	Amgen

Country where clinical trial is conducted

United States, 

References & Publications (17)

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

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. — View Citation

Chang VT, Ingham J. Symptom control. Cancer Invest. 2003;21(4):564-78. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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

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

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. — View Citation

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

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

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. — View Citation

Patrick DL, Ferketich SL, Frame PS, Harris JJ, Hendricks CB, Levin B, Link MP, Lustig C, McLaughlin J, Ried LD, Turrisi AT 3rd, Unützer 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Theobald DE, Butler D, Abdullah M, Perkins A, Edgerton S, Dugan WM. Access to communication technologies in a sample of cancer patients in Indiana: An urban and rural survey. (Poster Discussion) National Rural Health Meetings, San Diego, 2004.

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.

* Note: There are 17 references in all — Click here to view all references