Telephone Counseling: Men With Prostate Cancer & Partners

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telephone Counseling With Men With Prostate Cancer and Partners

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Telephone Interpersonal Counseling
* Behavioral: Telephone delivered education only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone Interpersonal Counseling<br>Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes. | Behavioral: Telephone Interpersonal Counseling<br>* Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.<br>|
| Active Comparator: Telephone delivered education only<br>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. | Behavioral: Telephone delivered education only<br>* Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosocial Intervention, Men with Prostate Cancer & Partners