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

Psychoeducation for Spouses/Partners of Women With Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Anxiety Disorder; Psychosocial Effects of Cancer and Its Treatment; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIIC Breast Cancer; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ
• Intervention / Treatment: Other: educational intervention; Other: educational intervention; Other: counseling intervention; Other: psychosocial support for caregiver

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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (educational booklet); 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.	Other: educational intervention; Receive the "What's Happening to the Woman I Love?" booklet; Other Names: intervention, educational; Other: educational intervention; Undergo Helping Her Heal educational counseling program; Other Names: intervention, educational
Experimental: Arm II (Helping Her Heal program); 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.	Other: educational intervention; Receive the "What's Happening to the Woman I Love?" booklet; Other Names: intervention, educational; Other: educational intervention; Undergo Helping Her Heal educational counseling program; Other Names: intervention, educational; Other: counseling intervention; Undergo Helping Her Heal educational counseling program; Other Names: counseling and communications studies; Other: psychosocial support for caregiver; Undergo Helping Her Heal educational counseling program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Frances Lewis, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• Lewis FM, Griffith KA, Alzawad Z, Dawson PL, Zahlis EH, Shands ME. Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples. Psychooncology. 2019 Feb;28(2):430-438. doi: 10.1002/pon.4966. Epub 2018 Dec 28.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Anxiety Disorders; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Carcinoma, Ductal, Breast
• Other Study ID Numbers: 8061 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2013-01838 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 34500; R01CA114561 (U.S. NIH Grant/Contract)