Telephone Counseling: Men With Prostate Cancer & Partners
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Telephone Interpersonal Counseling
Telephone delivered education only
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Psychosocial Intervention, Men with Prostate Cancer & Partners
Eligibility 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
Sites / Locations
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telephone Interpersonal Counseling
Telephone delivered education only
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Center for Epidemiological Studies-Depression Scale
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
Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.
Positive Affect
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
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
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
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
Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.
Secondary Outcome Measures
Full Information
NCT ID
NCT00822510
First Posted
January 12, 2009
Last Updated
April 10, 2018
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00822510
Brief Title
Telephone Counseling: Men With Prostate Cancer & Partners
Official Title
Telephone Counseling With Men With Prostate Cancer and Partners
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Psychosocial Intervention, Men with Prostate Cancer & Partners
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone Interpersonal Counseling
Arm Type
Experimental
Arm Description
Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.
Arm Title
Telephone delivered education only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Interpersonal Counseling
Intervention Description
Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Telephone delivered education only
Intervention Description
Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation
Primary Outcome Measure Information:
Title
Center for Epidemiological Studies-Depression Scale
Description
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.
Time Frame
3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks
Title
Perceived Stress
Description
Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.
Time Frame
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Title
Positive Affect
Description
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.
Time Frame
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Title
Negative Affect
Description
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.
Time Frame
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Title
Multidimensional Fatigue Inventory
Description
Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.
Time Frame
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Title
Social Well Being
Description
Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.
Time Frame
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Title
Spiritual Well Being
Description
Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.
Time Frame
3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Badger, PhD, RN
Organizational Affiliation
University of Arizona College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://nursing.arizona.edu
Description
College of Nursing Webpage
Learn more about this trial
Telephone Counseling: Men With Prostate Cancer & Partners
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