Clinical trial NCT00822510: Telephone Counseling: Men With Prostate Cancer & Partners
Official title: Telephone Counseling With Men With Prostate Cancer and Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Psychosocial Intervention
Men with Prostate Cancer & Partners
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-01-14
Enrollment: 79
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Center for Epidemiological Studies-Depression Scale
timeFrame: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks
measure: Perceived Stress
timeFrame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
measure: Positive Affect
timeFrame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
measure: Negative Affect
timeFrame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
measure: Multidimensional Fatigue Inventory
timeFrame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
measure: Social Well Being
timeFrame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
measure: Spiritual Well Being
timeFrame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona College of Nursing
name: Terry Badger, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: