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

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ClinicalTrials.gov Identifier: NCT01723943
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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: psychosocial support for caregiver Not Applicable

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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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  (Clinical Trial)
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 : March 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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 Name: counseling and communications studies

Other: educational intervention
Undergo Helping Her Heal educational counseling program
Other Name: intervention, educational

Other: psychosocial support for caregiver
Undergo Helping Her Heal educational counseling program




Primary Outcome Measures :
  1. Change in State-Trait Anxiety Inventory (STAI) spouse scores [ Time Frame: 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).

  2. Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores [ Time Frame: 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.

  3. Change in STAI patient scores [ Time Frame: 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.

  4. Change in CES-D patient scores [ Time Frame: 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 :
  1. Change in spouse/partner Skills Checklist scores [ Time Frame: 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.

  2. Change in spouse/partner CASE scores [ Time Frame: 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.

  3. Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores [ Time Frame: 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.

  4. Change in patient MIS scores [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723943


Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Frances Lewis Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01723943     History of Changes
Obsolete Identifiers: NCT02032992
Other Study ID Numbers: 8061
NCI-2013-01838 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
34500
8061 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
R01CA114561 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Anxiety Disorders
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Mental Disorders
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary