Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients
NCT ID: NCT01723943
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2009-03-31
2014-12-31
Brief Summary
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Detailed Description
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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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
educational intervention
Receive the "What's Happening to the Woman I Love?" booklet
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.
counseling intervention
Undergo Helping Her Heal educational counseling program
educational intervention
Undergo Helping Her Heal educational counseling program
psychosocial support for caregiver
Undergo Helping Her Heal educational counseling program
Interventions
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educational intervention
Receive the "What's Happening to the Woman I Love?" booklet
counseling intervention
Undergo Helping Her Heal educational counseling program
educational intervention
Undergo Helping Her Heal educational counseling program
psychosocial support for caregiver
Undergo Helping Her Heal educational counseling program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 and/or spouse not able to read and write in English
* Spouses could not participate if the ill partner refused participation
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Frances Lewis
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Lewis FM, Griffith KA, Alzawad Z, Dawson PL, Zahlis EH, Shands ME. Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples. Psychooncology. 2019 Feb;28(2):430-438. doi: 10.1002/pon.4966. Epub 2018 Dec 28.
Other Identifiers
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NCI-2013-01838
Identifier Type: REGISTRY
Identifier Source: secondary_id
34500
Identifier Type: -
Identifier Source: secondary_id
8061
Identifier Type: OTHER
Identifier Source: secondary_id
8061
Identifier Type: -
Identifier Source: org_study_id
NCT02032992
Identifier Type: -
Identifier Source: nct_alias
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