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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01723943
First received: November 6, 2012
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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 Intervention
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
Other: questionnaire administration
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Psychoeducation for Spouses/Partners of Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in State-Trait Anxiety Inventory (STAI) spouse scores [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 Depression Anxiety Stress scale (DAS) spouse scores [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 DAS patient scores [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 Skills Checklist scores [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 CASE scores [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Distribution of stress-related biomarkers in spouse caregivers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measures of central tendency will be computed (mean, mode, median, standard deviation, kertosis, skewness). Comparisons will be made with normative samples.

  • Distribution of stress-related biomarkers in spouse caregivers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measures of central tendency will be computed (mean, mode, median, standard deviation, kertosis, skewness). Comparisons will be made with normative samples.

  • Change in biomarkers over time [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    The Wilcoxon Signed Ranks Test will be computed to examine within group differences, comparing baseline with 3-month follow up data separately in the experimental and separately in the control groups.

  • Relationship between the biomarkers and standardized questionnaires of spouses' depressed mood, anxiety, and behavioral-emotional adjustment [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Correlational analyses using non-parametric statistics will be computed to examine relationships between the biomarkers and the total and subscale scores of the standardized questionnaires.


Estimated Enrollment: 750
Study Start Date: March 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
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
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723943

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Frances Lewis    206-685-0808    fmlewis@u.washington.edu   
Principal Investigator: Frances Lewis         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Frances Lewis Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01723943     History of Changes
Obsolete Identifiers: NCT02032992
Other Study ID Numbers: 8061, NCI-2013-01838, 34500, 8061, P30CA015704, R01CA114561
Study First Received: November 6, 2012
Last Updated: June 27, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 29, 2014