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NCT Number: NCT01723943

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

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.

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Key information

Conditions

Anxiety Disorder Adenocarcinoma Anxiety Disorders Behavior Behavioral Symptoms Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Depression Ductal Breast Carcinoma In Situ Lobular Breast Carcinoma in Situ Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Psychosocial Effects of Cancer and Its Treatment Skin Diseases Skin and Connective Tissue Diseases Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive the "What's Happening to the Woman I Love?" booklet

Other names: intervention, educational

counseling intervention

Other

Undergo Helping Her Heal educational counseling program

Other names: counseling and communications studies

Psychosocial Support for Caregiver

Other

Undergo Helping Her Heal educational counseling program

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Psychoeducation for Spouses/Partners of Women With Breast Cancer

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2012
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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