Spousal Relationships and Pain in Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 1
- 主要终点
- Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses.
研究概览
简要总结
Ecological Momentary Assessment (EMA) refers to the collection of repeated measurements of phenomena as they occur in naturalistic settings using hand-held computers. By providing an EMA of psychosocial variables that influence patient pain and pain behaviors, this study seeks to characterize the pain experience in metastatic breast cancer from both patients' and spouses' perspectives.
This study consists of two parts. Part 1 involves developing and pilot testing a hand-held computer program designed to assess antecedents, behaviors, and consequences of patient pain, as well as spouse response to pain. Five couples will complete a baseline survey and carry the hand-held computer for two weeks. They will be interviewed for feedback to refine the program. Part 2 is a longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. The Optional Procedure for Part 2 involves using electronic diaries (EDs) to measure the cancer pain experience for patients with metastatic breast cancer and their spouses.
The specific aims of this study are to: (1) To examine patient pain, spouse response to patient pain, and patient behaviors in response to pain over the course of 6 months in couples facing metastatic breast cancer, (2) test the biopsychosocial model of chronic pain in breast cancer; expanding it to include the influence of patient psychological functioning, spouse psychological functioning, and relationship functioning, on patient pain, spouse behaviors, and patient behaviors in response to pain, (3) use ecological momentary assessment to characterize patient pain, spouse response to patient pain, and patient behaviors in response to pain.
详细描述
Part 1:
Women with metastatic breast cancer will be asked to take part in the study. Project staff will review patients' medical records to determine their eligibility for the study. Eligible patients will be approached by a project staff member when they begin treatment for metastatic disease.
By agreeing to participate, you are agreeing to allow the study staff to contact your spouse. Spouses who are not present at the time patients are consented will not be asked to participate. Interested patients may still participate in this study even if their spouse is unwilling or unable to participate.
A project staff member will show participants how to use hand-held computers. Learning to use the computers does not require previous computer experience. Participants will take the computers home and, when signaled by the computer, answer a brief series of questions about how they are feeling physically and emotionally at that particular moment.
Participants will be prompted to answer questions 6 times a day, for 14 days after starting treatment. It should take about 2 minutes to answer the questions each time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Patients: Being a female patient diagnosed with metastatic breast cancer.
- •For Patients: Initiating treatment for metastatic breast cancer
- •For Patients: Having and ECOG Performance Status Score of 2 or less
- •For Spouses: Being the male spouse or significant other of a female patient diagnosed with metastatic breast cancer
- •For Spouses: Having the patient's consent to be contacted
- •For Patients and Spouses: Having the ability to read and speak English well enough to understand the consent form and complete the questionnaires
- •For Patients and Spouses: Being able to provide informed consent
排除标准
- •For Patients and Spouses: Not being able to provide informed consent.
- •For Patients: Rating average pain as 0 on the BPI
结局指标
主要结局
Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses.
时间窗: 6 Months
次要结局
- Pilot of hand-held computers at home for metastatic breast cancer patient and spouses to answer questions about pain and other symptoms.(14 Days (Survey Response + 30 Minute Interview))