Telephone Counseling: Men With Prostate Cancer & Partners
Telephone Counseling With Men With Prostate Cancer and Partners
2 other identifiers
interventional
79
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Sep 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 12, 2009
CompletedFirst Posted
Study publicly available on registry
January 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
June 23, 2016
CompletedMay 11, 2018
June 1, 2016
3 years
January 12, 2009
November 30, 2015
April 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks
Perceived Stress
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
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
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
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
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
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)
Study Arms (2)
Telephone Interpersonal Counseling
EXPERIMENTALTelephone 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
ACTIVE COMPARATORTelephone 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.
Interventions
Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.
Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- under 21 years
- Does not speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Arizona
Tucson, Arizona, 85721, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Terry Badger, PhD, PMHCNS-BC, FAAN
- Organization
- University of Arizona College of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Terry Badger, PhD, RN
University of Arizona College of Nursing
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 12, 2009
First Posted
January 14, 2009
Study Start
September 1, 2006
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
May 11, 2018
Results First Posted
June 23, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share