Telephone Counseling: Men With Prostate Cancer & Partners

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Terry Badger, University of Arizona
ClinicalTrials.gov Identifier:
NCT00822510
First received: January 12, 2009
Last updated: June 22, 2016
Last verified: June 2016
  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 Counseling
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
Official Title: Telephone Counseling With Men With Prostate Cancer and Partners

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Center for Epidemiological Studies-Depression Scale [ Time Frame: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks ] [ Designated as safety issue: No ]
    Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression.

  • Perceived Stress [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ] [ Designated as safety issue: No ]
    Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.

  • Positive Affect [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ] [ Designated as safety issue: No ]
    Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.

  • Negative Affect [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ] [ Designated as safety issue: No ]
    Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.

  • Multidimensional Fatigue Inventory [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ] [ Designated as safety issue: No ]
    Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.

  • Social Well Being [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ] [ Designated as safety issue: No ]
    Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.

  • Spiritual Well Being [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ] [ Designated as safety issue: No ]
    Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.


Enrollment: 79
Study Start Date: September 2006
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone Interpersonal Counseling
Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.
Behavioral: Telephone Interpersonal Counseling
Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.
Active Comparator: Telephone delivered education only
Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes.
Behavioral: Telephone delivered education only
Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation

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   (Adult, Senior)
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.

Exclusion Criteria:

  • under 21 years
  • Does not speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822510

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Principal Investigator: Terry Badger, PhD, RN University of Arizona College of Nursing
  More Information

Additional Information:
Responsible Party: Terry Badger, Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT00822510     History of Changes
Other Study ID Numbers: 04-0376-02  R21CA113409 
Study First Received: January 12, 2009
Results First Received: November 30, 2015
Last Updated: June 22, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 August 25, 2016