Telephone Counseling: Men With Prostate Cancer & Partners

Phase 1

Completed

Conditions: Prostate Cancer

Interventions: Behavioral: Telephone Interpersonal Counseling
Behavioral: Telephone delivered education only

Registration Number: NCT00822510

Lead Sponsor: University of Arizona

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 79

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telephone Interpersonal Counseling	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 education only	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.

Primary Outcome Measures

Name	Time	Method
Spiritual Well Being	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.
Social Well Being	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.
Center for Epidemiological Studies-Depression Scale	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.
Positive Affect	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.
Perceived Stress	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.
Negative Affect	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.
Multidimensional Fatigue Inventory	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.