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Telephone Counseling: Men With Prostate Cancer & Partners

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University of Arizona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00822510
First received: January 12, 2009
Last updated: January 13, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this project is to test a telephone delivered educational support program versus an education only program for improving symptom management and quality of life in men with prostate cancer and their partners.


Condition Intervention Phase
Prostate Cancer
 Behavioral: Telephone Interpersonal Counselling Intervention
Behavioral: Telephone delivered education only
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2006
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Telephone delivered education and support for 8 weeks
 Behavioral: Telephone Interpersonal Counselling Intervention
Telephone delivered 8 week education and support intervention
Active Comparator: 2
Telephone delivered education only for 8 weeks
 Behavioral: Telephone delivered education only
Telephone delivered education for 8 weeks

Detailed Description:

Eligibility Criteria for men: receiving treatment for prostate cancer,over 21 years of age, English speaking, have access to and ability to talk on the phone and have a partner willing to participate in the study. Participants can live anywhere in the United States because the intervention is telephone delivered.

Partners can be anyone the man selects (friend or relative) who is over 21 years of age, English speaking and has access to or ability to speak on the phone.

Men and their partners will be assigned to one of two groups. Each survivor will receive 8 telephone calls over an 8-week period for about 30 minutes each. Each partner will receive 4 telephone calls every other week for about 30 minutes each. We will ask everyone to complete a baseline assessment over the telephone, after the 8 weeks, and then again about 8 weeks after the second assessment.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving treatment for prostate cancer
  • Over 21 years
  • Access to and ability to talk on the phone
  • Speaks English and has a partner to participate with him.
  • Partners are anyone who the man chooses (friend or relative) who is over 21 years, English speaking and has access and ability to talk on the phone.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822510

Contacts
Contact: Maria Figueroa 866-218-6641 (toll free) figueroa@nursing.arizona.edu
Contact: Terry Badger, PhD, RN 866-218-6641 (toll free) tbadger@nursing.arizona.edu

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721
Contact: Maria Figueroa     866-241-6641     figueroa@nursing.arizona.edu    
Contact: Terry Badger, PhD, RN     866-241-6641     tbadger@nursing.arizona.edu    
Principal Investigator: Terry Badger, PhD, RN            
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Terry Badger, PhD, RN University of Arizona College of Nursing
  More Information

Additional Information:
College of Nursing Webpage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Terry Badger, PhD, RN, FAAN, University of Arizona College of Nursing
ClinicalTrials.gov Identifier: NCT00822510     History of Changes
Other Study ID Numbers: 04-0376-02, R21CA113409
Study First Received: January 12, 2009
Last Updated: January 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Psychosocial Intervention
Men with Prostate Cancer & Partners

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013