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

NCT01723943 | Completed

• 5 other identifiers: 8061NCI-2013-0183834500P30CA015704R01CA114561
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Change in State-Trait Anxiety Inventory (STAI) spouse scores

  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

  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

  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

  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 Outcomes (4)

• Change in spouse/partner Skills Checklist scores

  Baseline to 8 weeks

• Change in spouse/partner CASE scores

  Baseline to 8 weeks

• Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores

  Baseline to 8 weeks

• Change in patient MIS scores

  Baseline to 8 weeks

Study Arms (2)

Arm I (educational booklet)

ACTIVE COMPARATOR

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

Arm II (Helping Her Heal program)

EXPERIMENTAL

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

Interventions

educational intervention OTHER

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

Also known as: intervention, educational

Arm I (educational booklet)

counseling intervention OTHER

Undergo Helping Her Heal educational counseling program

Also known as: counseling and communications studies

Arm II (Helping Her Heal program)

psychosocial support for caregiver OTHER

Undergo Helping Her Heal educational counseling program

Arm II (Helping Her Heal program)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 30549145 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Early Intervention, Educational; Methods; Counseling; Psychiatric Rehabilitation; Caregivers

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques; Mental Health Services; Behavioral Disciplines and Activities; Rehabilitation; Therapeutics; Health Personnel

Study Officials

• Frances Lewis

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: March 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (1)