Telephone Counseling: Men With Prostate Cancer & Partners

NCT ID: NCT00822510

Last Updated: 2018-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-10-31

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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Telephone Interpersonal Counseling

Intervention Type BEHAVIORAL

Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.

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.

Group Type ACTIVE_COMPARATOR

Telephone delivered education only

Intervention Type BEHAVIORAL

Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation

Interventions

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Telephone Interpersonal Counseling

Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.

Intervention Type BEHAVIORAL

Telephone delivered education only

Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Terry Badger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry Badger, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Arizona College of Nursing

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Countries

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United States

Related Links

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http://nursing.arizona.edu

College of Nursing Webpage

Other Identifiers

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R21CA113409

Identifier Type: NIH

Identifier Source: secondary_id

View Link

04-0376-02

Identifier Type: -

Identifier Source: org_study_id

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