NCT02085096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jul 1997

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

5.4 years

First QC Date

March 10, 2014

Last Update Submit

March 3, 2020

Conditions

Prostate Cancer

Keywords

CaregiversCoping Skills

Outcome Measures

Primary Outcomes (1)

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

    From baseline to follow-ups at post-intervention (2-3 months post-baseline) and 6-months post-baseline

Study Arms (2)

Problem-Solving Therapy

EXPERIMENTAL

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.

Behavioral: Problem-Solving Therapy

Standard Supportive Care

PLACEBO COMPARATOR

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

Behavioral: Problem-Solving Therapy

Interventions

Problem-Solving TherapyBEHAVIORAL

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.

Problem-Solving TherapyStandard Supportive Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (5)

  • 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.

    PMID: 12690945BACKGROUND

  • 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.

    PMID: 15657688BACKGROUND

  • 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.

    PMID: 16858462BACKGROUND

  • 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.

    PMID: 17177907BACKGROUND

  • 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.

    PMID: 20680885BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Georgia R Sadler, PhD

    UC San Diego Moores Cancer Center

    PRINCIPAL INVESTIGATOR

  • Vanessa L Malcarne, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

July 1, 1997

Primary Completion

December 1, 2002

Study Completion

September 1, 2005

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)