Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,584
- 试验地点
- 1
- 主要终点
- depressive symptoms
研究概览
简要总结
The purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment process in both patients and partners. The overall aim is to generate knowledge that helps enables us to integrate the partners' needs, problems and resources in treatment and rehabilitation of breast cancer patients.
详细描述
Breast cancer is a major life event. A patient's experience of breast cancer may depend heavily on her intimate partner. However, both patients and partners may experience depressed mood or other psychosocial adjustment problems. Individual and relationship factors, such as the couple's joint efforts to deal with the cancer experience, are likely to contribute to their psychosocial adjustment. More knowledge is needed on the adjustment problems patients and partners experience and how they deal with them.
The study investigates the following research questions:
- Which psychosocial adjustment problems do patients and partners experience throughout the cancer trajectory?
- To what extent do the patient's psychosocial adjustment problems influence the partner's psychosocial adjustment problems and vice versa?
- Which factors are associated with psychosocial adjustment problems?
- How do different strategies of dyadic coping influence the psychosocial adjustment of both the patient and the partner?
A prospective, population-based cohort will be established of women diagnosed with breast cancer in Denmark and their partners. The study combines questionnaire data and data from nationwide clinical and administrative registries.
An invitation letter and study material will be sent to patients by mail. Patients will be asked to invite their partner to participate in the study. Only couples in which both the patient and the partner wish to participate will be asked to complete the questionnaire at 5 and 12 months of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients: being a female patient diagnosed with primary breast cancer within the last four months
- •For patients: cohabiting with a male partner/spouse
- •For partners: being the male cohabiting partner/spouse of a patient diagnosed with primary breast cancer within the last four months
排除标准
- •For patients: previous diagnosis of breast cancer or breast cancer relapse
结局指标
主要结局
depressive symptoms
时间窗: 12-months follow up
self-report questionnaire CES-D
quality of life
时间窗: 12-months follow up
self-report questionnaire SF-36
dyadic coping
时间窗: 12-months follow up
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
次要结局
- sexual functioning(12-months follow up)
- body image(12-months follow up)
- relationship functioning(12-months follow up)
- symptom experience(12-months follow up)
- work ability(12-months follow up)
- partner's involvement in breast cancer(12-months follow up)
- illness perceptions(baseline)
- use of antidepressants(12-months follow up)
- dimensions of sleep(12-months follow up)
研究者
Nina Rottmann
MSc
University of Southern Denmark