Effects of a Group Residential Retreat on Cancer Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Compliance in Residential Retreat Program
研究概览
简要总结
The goal of this behavioral research study is to compare 2 different types of residential group programs to help researchers learn if and how well these groups may help to improve physical and emotional well-being in patients with stage IV breast cancer.
详细描述
Baseline Visit:
Signing this consent form does not mean that you will be able to take part in this study. The following baseline tests will help the doctor decide if you are eligible:
- You will complete 7 questionnaires about your mood, sleep, fatigue, how you have been feeling, and your general quality of life. The questionnaires should take about 60-80 minutes to complete.
- You will have an electroencephalogram (EEG) to check your brain's electrical activity. During the EEG, a snug cap with small electrodes will be placed on your head to measure the electrical patterns coming from the brain. This is like the way a doctor listens to your heart from the surface of your skin. During the EEG, you will complete 3 tests to check your attention, short-term memory, and levels of emotions on the computer. The study staff will discuss each test in more detail with you. The EEG and tests will take about 45-60 minutes total.
- If you have not had a computed tomography (CT) scan in the last 2 months, you will have one performed to check the status of the disease. If you have had one in the last 2 months, the results will be collected from your medical records.
- You will have an electrocardiogram (EKG) to check your heart function.
- Blood (about 6 tablespoons) will be drawn for tests to measure hormones and your immune system responses. You will need to fast (not eat or drink anything except water) for 12 hours before this blood draw. You will be provided with healthy snacks after your blood draw.
The day after your baseline visit, saliva will be collected to measure the level of cortisol (a type of stress hormone) in your body. These saliva samples will be collected 4 times each day for 3 days in a row. You will collect these samples at home when you first wake up, about 45 minutes later, about 10 hours after waking up, and then at bedtime. To collect each saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will write down the times you took these samples. You will mail these samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.
Every day for the next 7 days after your baseline visit, you will fill out a diary about your sleeping habits. You will also wear a special type of wrist watch for these 7 days. The watch will collect data about your physical activity and sleeping habits. After you have worn it for 7 days, you will mail the watch and the sleep diary back to MD Anderson in postage-paid envelopes that will be provided to you.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 50 and over initially diagnosed with breast cancer by histological tissue diagnosis in 2003 or later.
- •Currently Stage IV (metastatic) breast cancer on the basis of definitive imaging or biopsy with stable disease (scans within the past 2 months).
- •ECOG (Eastern Cooperative Group) Performance Score of 0 or
- •Able to participate occasionally in mildly strenuous physical effort.
- •Able to read, speak, and write in English or ability to provide consent or understand questionnaires.
- •Able to be accompanied by their spouse or significant other partner/friend (spouse, significant other, partner, or friend.
- •Able to travel to the retreat site.
- •Must be right handed.
- •Patients must have had a contrast-enhanced computerized tomographic (CT) scan of the chest and abdomen within 2 months of study entry and be willing to have a follow up scan within 2 months of the completion of the retreat.
- •(CAREGIVERS ONLY) Must be primary caregiver of the patient.
- •(CAREGIVERS ONLY) Able to read, speak, and write in English.
- •(CAREGIVERS ONLY) Able to attend the last two days of the retreat with patient.
排除标准
- •Significant co-morbidities (e.g., diabetes, cardiac disease, or other condition that in the opinion of the primary physician or investigators would limit participation in the intervention groups) that would preclude study participation.
- •Evidence of disease progression that would necessitate a treatment in the next 2 weeks.
- •Need for intravenous therapy more frequently than every 3 weeks or inability to time intravenous therapy treatment before and after the study.
- •Currently in treatment for a major psychiatric disorder
- •Clinical history of severe psychiatric disorders.
- •Currently receiving chemotherapy.
- •(CAREGIVERS ONLY) Must be an adult (>=18 years old).
研究组 & 干预措施
Experimental Support Group (ESG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Residential Program (Behavioral)
Experimental Support Group (ESG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Questionnaires (Behavioral)
Experimental Support Group (ESG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Electroencephalogram (EEG) (Device)
Experimental Support Group (ESG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Saliva Testing (Other)
Experimental Support Group (ESG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Study Diary plus Actigraph (Behavioral)
Standard Support Group (SSG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Residential Program (Behavioral)
Standard Support Group (SSG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Questionnaires (Behavioral)
Standard Support Group (SSG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Electroencephalogram (EEG) (Device)
Standard Support Group (SSG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Saliva Testing (Other)
Standard Support Group (SSG) - Residential Program
Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Study Diary plus Actigraph (Behavioral)
Standard of Care Group (SOC) - No Residential Program
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Questionnaires (Behavioral)
Standard of Care Group (SOC) - No Residential Program
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Electroencephalogram (EEG) (Device)
Standard of Care Group (SOC) - No Residential Program
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Saliva Testing (Other)
Standard of Care Group (SOC) - No Residential Program
Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.
干预措施: Study Diary plus Actigraph (Behavioral)
结局指标
主要结局
Compliance in Residential Retreat Program
时间窗: 3 months
Participant compliance with assessments monitored as well as participation in all aspects of the intervention program. Intervention deemed feasible if ≥ 60% of enrolled couples complete all assessments and attend the assigned retreat.
次要结局
未报告次要终点