Telephone Counseling: Men With Prostate Cancer & Partners

Prostate Cancer Clinical Trial

Official title:

Telephone Counseling With Men With Prostate Cancer and Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822510
• Other study ID #: 04-0376-02
• Secondary ID: R21CA113409
• Status: Completed
• Phase: Phase 1
• Start date: September 2006
• Est. completion date: October 2009

Study information

• Verified date: June 2016
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Telephone Interpersonal Counseling
Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.
• Telephone delivered education only
Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

•   College of Nursing Webpage