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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02085096
Other study ID # 5180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1997
Est. completion date September 2005

Study information

Verified date March 2020
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 338
Est. completion date September 2005
Est. primary completion date December 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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:

-

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Problem-Solving Therapy
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.

Locations

Country Name City State
United States UC San Diego Moores Cancer Center La Jolla California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Diego San Diego State University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Epub 2005 Jan 19. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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