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Problem Solving Therapy for Prostate Cancer Spousal Caregivers

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Therapy
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Caregivers, Coping Skills

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosed with prostate cancer within 18 months of study enrollment.
  • The patient and significant other cohabited
  • Couples resided in San Diego County
  • Both patient and significant other were sufficiently proficient in English

Exclusion Criteria:

-

Sites / Locations

  • UC San Diego Moores Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Problem-Solving Therapy

Standard Supportive Care

Arm Description

A problem-solving therapy training program will be provided to the spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.

Participants who are randomized to this arm will be encouraged to use whatever supporting care is recommended to them by their health provider.

Outcomes

Primary Outcome Measures

Change from Baseline of Effects of Stress and Coping to Follow-ups

Secondary Outcome Measures

Full Information

First Posted
March 10, 2014
Last Updated
March 3, 2020
Sponsor
University of California, San Diego
Collaborators
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT02085096
Brief Title
Problem Solving Therapy for Prostate Cancer Spousal Caregivers
Official Title
Problem-Solving Therapy for Prostate Cancer Patient's Spousal Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
Detailed Description
Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients. Participants were randomly assigned to an experimental group which received problem-solving therapy, or to a control group which relied on their standard methods of coping (e.g. their normal therapist, family and friends). Participants completed baseline surveys regarding their distress and coping prior to randomization. They then completed these surveys again at post-intervention (approximately 2-3 months post-baseline) and 6 months post-baseline to determine lasting effects of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Caregivers, Coping Skills

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem-Solving Therapy
Arm Type
Experimental
Arm Description
A problem-solving therapy training program will be provided to the spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
Arm Title
Standard Supportive Care
Arm Type
Placebo Comparator
Arm Description
Participants who are randomized to this arm will be encouraged to use whatever supporting care is recommended to them by their health provider.
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Therapy
Intervention Description
Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
Primary Outcome Measure Information:
Title
Change from Baseline of Effects of Stress and Coping to Follow-ups
Time Frame
From baseline to follow-ups at post-intervention (2-3 months post-baseline) and 6-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with prostate cancer within 18 months of study enrollment. The patient and significant other cohabited Couples resided in San Diego County Both patient and significant other were sufficiently proficient in English Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgia R Sadler, PhD
Organizational Affiliation
UC San Diego Moores Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa L Malcarne, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12690945
Citation
Banthia R, Malcarne VL, Varni JW, Ko CM, Sadler GR, Greenbergs HL. The effects of dyadic strength and coping styles on psychological distress in couples faced with prostate cancer. J Behav Med. 2003 Feb;26(1):31-52. doi: 10.1023/a:1021743005541.
Results Reference
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PubMed Identifier
15657688
Citation
Ko CM, Malcarne VL, Varni JW, Roesch SC, Banthia R, Greenbergs HL, Sadler GR. Problem-solving and distress in prostate cancer patients and their spousal caregivers. Support Care Cancer. 2005 Jun;13(6):367-74. doi: 10.1007/s00520-004-0748-5. Epub 2005 Jan 19.
Results Reference
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PubMed Identifier
16858462
Citation
Hawes S, Malcarne V, Ko C, Sadler G, Banthuia R, Sherman S, Varni J, Schmidt J. Identifying problems faced by spouses and partners of patients with prostate cancer. Oncol Nurs Forum. 2006 Jul 1;33(4):807-14. doi: 10.1188/06.ONF.807-814.
Results Reference
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PubMed Identifier
17177907
Citation
Yoshimoto SM, Ghorbani S, Baer JM, Cheng KW, Banthia R, Malcarne VL, Sadler GR, Ko CM, Greenbergs HL, Varni JW. Religious coping and problem-solving by couples faced with prostate cancer. Eur J Cancer Care (Engl). 2006 Dec;15(5):481-8. doi: 10.1111/j.1365-2354.2006.00700.x.
Results Reference
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PubMed Identifier
20680885
Citation
Merz EL, Malcarne VL, Ko CM, Sadler M, Kwack L, Varni JW, Sadler GR. Dyadic concordance among prostate cancer patients and their partners and health-related quality of life: does it matter? Psychol Health. 2011 Jun;26(6):651-66. doi: 10.1080/08870441003721251. Epub 2011 Jul 11.
Results Reference
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Problem Solving Therapy for Prostate Cancer Spousal Caregivers

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