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

University of Washington

Status: Completed

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Anxiety Disorder; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Lobular Breast Carcinoma in Situ; Psychosocial Effects of Cancer and Its Treatment; Ductal Breast Carcinoma in Situ; Depression

Treatments: Other: educational intervention; Other: counseling intervention; Other: psychosocial support for caregiver

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01723943

8061 (Other Identifier)

NCI-2013-01838 (Registry Identifier)

R01CA114561 (U.S. NIH Grant/Contract)

P30CA015704 (U.S. NIH Grant/Contract)

34500

Details and patient eligibility

About

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.

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SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the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

Enrollment: 108 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Arm I (educational booklet)

Active Comparator group

Description:

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.

Treatment:

Other: educational intervention

Other: educational intervention

Arm II (Helping Her Heal program)

Experimental group

Description:

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.

Treatment:

Other: psychosocial support for caregiver

Other: educational intervention

Other: counseling intervention

Other: educational intervention