Clinical trial NCT01723943: Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients
Official title: Psychoeducation for Spouses/Partners of Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-11-08
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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

Primary outcomes:
measure: Change in State-Trait Anxiety Inventory (STAI) spouse scores
timeFrame: Baseline to 8 weeks
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores
timeFrame: Baseline to 8 weeks
measure: Change in STAI patient scores
timeFrame: Baseline to 8 weeks
measure: Change in CES-D patient scores
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in spouse/partner Skills Checklist scores
timeFrame: Baseline to 8 weeks
measure: Change in spouse/partner CASE scores
timeFrame: Baseline to 8 weeks
measure: Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores
timeFrame: Baseline to 8 weeks
measure: Change in patient MIS scores
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Frances Lewis
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.