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

Study Overview
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Brief Summary
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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.

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 SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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

Official Title
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Psychoeducation for Spouses/Partners of Women With Breast Cancer

Conditions
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Depression, Ductal Breast Carcinoma in Situ, Anxiety Disorder, 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 / Treatment
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* Other: educational intervention
* Other: counseling intervention
* Other: educational intervention
* Other: psychosocial support for caregiver


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |