Psychoeducation for Spouses/Partners of Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores
时间窗: 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.
Change in CES-D patient scores
时间窗: 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.
Change in State-Trait Anxiety Inventory (STAI) spouse scores
时间窗: 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).
Change in STAI patient scores
时间窗: 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.
次要结局
- Change in patient MIS scores(Baseline to 8 weeks)
- 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)