Treatment-Related Symptom Management in Patients Treated for Localized Prostate Cancer - Full Text View

Sponsors and Collaborators:	Baylor College of Medicine National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00903487

Purpose

RATIONALE: Studying how men with localized prostate cancer managed their treatment-related side-effects may help doctors plan better treatment in the future.

PURPOSE: This clinical trial is studying treatment-caused symptom management in patients treated for localized prostate cancer.

Condition	Intervention
Prostate Cancer	Other: informational intervention Procedure: assessment of therapy complications

Study Type:	Interventional
Study Design:	Health Services Research, Open Label
Official Title:	A Qualitative Study of Prostate Cancer Symptom Management

Resource links provided by NLM:

MedlinePlus related topics: Cancer Palliative Care Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Access previously collected data [ Designated as safety issue: No ]
Hierarchical classification or taxonomy of critical symptom management competencies [ Designated as safety issue: No ]
Instructional objectives for a tailored intervention [ Designated as safety issue: No ]

Estimated Enrollment:	106
Study Start Date:	March 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To collect qualitative data from prostate cancer patients, their partners, and health-care providers describing effective and ineffective symptom-management knowledge, skills, and behaviors in men treated for localized prostate cancer.
To analyze qualitative data using the critical incident technique to develop a hierarchical classification or taxonomy of critical symptom-management competencies.
To use the taxonomy of symptom-management competencies from objective II to develop the instructional objectives for a tailored intervention to help these patients manage their treatment-related side-effects and related psychosocial concerns more effectively.

OUTLINE: Using the qualitative data collected during a 2003-2005 study from University of California, San Francisco database of prostate cancer patients, their partners, and health-care providers that describe effective and ineffective symptom-management knowledge, skills, and behaviors in men treated for localized prostate cancer is analyzed. From these data a hierarchical classification or taxonomy of critical symptom-management competencies is developed, eventually developing instructional objectives for a tailored intervention to manage these patients' treatment-related side-effects and quality of life.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of localized prostate cancer and treated with radiation therapy or surgery

PATIENT CHARACTERISTICS:

Able to speak, read, and understand English

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903487

Locations

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: David M. Latini, PhD 877-794-7852 canceroutcomes@bcm.edu

Sponsors and Collaborators

Baylor College of Medicine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

David M. Latini, PhD

Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dan L. Duncan Cancer Center at Baylor College of Medicine ( David M. Latini )
Study ID Numbers:	CDR0000600458, BCM-H-19322
Study First Received:	May 15, 2009
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00903487 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009