Telephone Counseling: Men With Prostate Cancer & Partners
April 10, 2018 updated by: Terry Badger, University of Arizona
Telephone Counseling With Men With Prostate Cancer and Partners
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85721
- University of Arizona
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks
|
|
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 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
|
|
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.
|
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
|
|
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.
|
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
|
|
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.
|
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
|
|
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.
|
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
|
|
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.
|
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Terry Badger, PhD, RN, University of Arizona College of Nursing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
January 12, 2009
First Submitted That Met QC Criteria
January 13, 2009
First Posted (Estimate)
January 14, 2009
Study Record Updates
Last Update Posted (Actual)
May 11, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-0376-02
- R21CA113409 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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