Clinical trial NCT02085096: Problem Solving Therapy for Prostate Cancer Spousal Caregivers
Official title: Problem-Solving Therapy for Prostate Cancer Patient's Spousal Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Caregivers
Coping Skills
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2014-03-12
Enrollment: 338
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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:

-

Primary outcomes:
measure: Change from Baseline of Effects of Stress and Coping to Follow-ups
timeFrame: From baseline to follow-ups at post-intervention (2-3 months post-baseline) and 6-months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
Study officials:
affiliation: UC San Diego Moores Cancer Center
name: Georgia R Sadler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Vanessa L Malcarne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.