Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients

Depression Clinical Trial

Official title:

Psychoeducation for Spouses/Partners of Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723943
• Other study ID #: 8061
• Secondary ID: NCI-2013-0183834
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: February 6, 2018
• Start date: March 2009
• Est. completion date: December 2014

Study information

• Verified date: February 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies educational counseling in improving communication and quality of life in spouses and breast cancer patients. An outpatient education and behavior skills training program may help spouses and patients with breast cancer communicate better and improve quality of life. It is not yet known whether educational counseling is more effective than an educational booklet in improving communication and quality of life.

Description:

PRIMARY OBJECTIVES:

I. To test whether the intervention has a beneficial effect on spouses' outcome variables.

II. To test whether the intervention has a beneficial effect on ill partners (patients') outcome variables.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Participants receive the "What's Happening to the Woman I Love?" booklet, which focuses on ways to understand and deal with marital communication and relationship issues arising from breast cancer diagnosis.

ARM II: Participants undergo the Helping Her Heal educational counseling program comprising 5 1-hour sessions 2 weeks apart.

SESSION I: Participants learn stress management skills and discover ways stress affects themselves and their partner.

SESSION II: Participants practice attentive listening and reduce the tendency to try to distract patients from talking about sad or difficult aspects of the cancer experience.

SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the cancer.

SESSION IV: Participants learn strategies for physically reconnecting with spouses.

SESSION V: Participants review skills from prior sessions, identify strategies he or she will continue to use to manage their personal stress, and identify ways to maintain connection and support.

After completion of study, patients are followed up at 3 and 6 months.

Other known NCT identifiers

• NCT02032992

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Spouses (in both heterosexual couples and same-sex couples) of women diagnosed within the past 6 months with stage 0, I, II or III breast cancer (in situ/local/regional disease) will be eligible to participate, as will the diagnosed wife/partner

• Spouses and patients must be married or cohabiting for at least 6 months

• Spouses and patients must have English as one of their languages of choice (they can be multilingual)

• Spouses and patients must live within 25 miles of the University of Washington (UW) study center

• Spouses/partners must be willing to give a sample of blood and/or sputum at time of first and second data collections

Exclusion Criteria:

• Woman diagnosed with stage IV or recurrent breast cancer or who is > 6 months post-diagnosis

• Woman and/or spouse not able to read and write in English

• Spouses could not participate if the ill partner refused participation

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• Depression
• Ductal Breast Carcinoma in Situ
• Lobular Breast Carcinoma in Situ
• Psychosocial Effects of Cancer and Its Treatment
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Intervention

Other:
• educational intervention
Receive the "What's Happening to the Woman I Love?" booklet
• counseling intervention
Undergo Helping Her Heal educational counseling program
• educational intervention
Undergo Helping Her Heal educational counseling program
• psychosocial support for caregiver
Undergo Helping Her Heal educational counseling program

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in State-Trait Anxiety Inventory (STAI) spouse scores	The primary analysis will be multivariate analysis of covariance (MANCOVA) with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include analysis of covariance (ANCOVA).	Baseline to 8 weeks
Primary	Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores	The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.	Baseline to 8 weeks
Primary	Change in STAI patient scores	The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.	Baseline to 8 weeks
Primary	Change in CES-D patient scores	The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.	Baseline to 8 weeks
Secondary	Change in spouse/partner Skills Checklist scores	Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.	Baseline to 8 weeks
Secondary	Change in spouse/partner CASE scores	Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.	Baseline to 8 weeks
Secondary	Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores	Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.	Baseline to 8 weeks
Secondary	Change in patient MIS scores	Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.	Baseline to 8 weeks