Telephone Counseling: Men With Prostate Cancer & Partners

Telephone Counseling With Men With Prostate Cancer and Partners

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Telephone Interpersonal Counseling; Behavioral: Telephone delivered education only

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Telephone Interpersonal Counseling; Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.
Active Comparator: 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.	Behavioral: Telephone delivered education only; Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Terry Badger, PhD, RN, University of Arizona College of Nursing

Publications and helpful links

Helpful Links

• College of Nursing Webpage

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 12, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (Estimate): January 14, 2009

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Psychosocial Intervention; Men with Prostate Cancer & Partners
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 04-0376-02; R21CA113409 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO