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Telephone Counseling: Men With Prostate Cancer & Partners

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00822510
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : June 23, 2016
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Terry Badger, University of Arizona

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Telephone Interpersonal Counseling Behavioral: Telephone delivered education only Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telephone Counseling With Men With Prostate Cancer and Partners
Study Start Date : September 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Center for Epidemiological Studies-Depression Scale [ Time Frame: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks ]
    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.

  2. Perceived Stress [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ]
    Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.

  3. Positive Affect [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ]
    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.

  4. Negative Affect [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ]
    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.

  5. Multidimensional Fatigue Inventory [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ]
    Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.

  6. Social Well Being [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ]
    Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.

  7. Spiritual Well Being [ Time Frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks) ]
    Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822510


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

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Responsible Party: Terry Badger, Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT00822510    
Other Study ID Numbers: 04-0376-02
R21CA113409 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2009    Key Record Dates
Results First Posted: June 23, 2016
Last Update Posted: May 11, 2018
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Terry Badger, University of Arizona:
Psychosocial Intervention
Men with Prostate Cancer & Partners
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases