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

February 6, 2018 updated by: University of Washington

Psychoeducation for Spouses/Partners of Women With Breast Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: educational intervention
Undergo Helping Her Heal educational counseling program
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: educational intervention
Receive the "What's Happening to the Woman I Love?" booklet
Other Names:
  • intervention, educational
Other: educational intervention
Undergo Helping Her Heal educational counseling program
Other Names:
  • intervention, educational
Other: counseling intervention
Undergo Helping Her Heal educational counseling program
Other Names:
  • counseling and communications studies
Other: psychosocial support for caregiver
Undergo Helping Her Heal educational counseling program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frances Lewis, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8061 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2013-01838 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 34500
  • R01CA114561 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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