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

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT01723943

Collaborator

National Cancer Institute (NCI) (NIH)

108

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder 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	Other: educational intervention Other: counseling intervention Other: educational intervention Other: psychosocial support for caregiver	N/A

Detailed Description

PRIMARY OBJECTIVES:

To test whether the intervention has a beneficial effect on spouses' outcome variables.
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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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 Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Supportive Care

Official Title:

Psychoeducation for Spouses/Partners of Women With Breast Cancer

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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
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: counseling intervention Undergo Helping Her Heal educational counseling program Other Names: counseling and communications studies Other: educational intervention Undergo Helping Her Heal educational counseling program Other Names: intervention, educational Other: psychosocial support for caregiver Undergo Helping Her Heal educational counseling program

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

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: counseling intervention

Undergo Helping Her Heal educational counseling program

Other Names:

counseling and communications studies

Other: educational intervention

Undergo Helping Her Heal educational counseling program

Other Names:

intervention, educational

Other: psychosocial support for caregiver

Undergo Helping Her Heal educational counseling program

Outcome Measures

Primary Outcome Measures

Change in State-Trait Anxiety Inventory (STAI) spouse scores [Baseline to 8 weeks]
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).
Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores [Baseline to 8 weeks]
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.
Change in STAI patient scores [Baseline to 8 weeks]
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.
Change in CES-D patient scores [Baseline to 8 weeks]
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.

Secondary Outcome Measures

Change in spouse/partner Skills Checklist scores [Baseline to 8 weeks]
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.
Change in spouse/partner CASE scores [Baseline to 8 weeks]
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.
Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores [Baseline to 8 weeks]
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.
Change in patient MIS scores [Baseline to 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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