Effects of a Group Residential Retreat on Cancer Outcomes
Breast Cancer
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Stage IV breast cancer, Metastatic, Residential group programs, Questionnaires, Surveys, EEG, Computer testing, Saliva test, Study diary, Actigraph
Eligibility Criteria
Inclusion Criteria:
- 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 1.
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
Experimental Support Group (ESG) - Residential Program
Standard Support Group (SSG) - Residential Program
Standard of Care Group (SOC) - No 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.
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.
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.