Clinical trial · Interventional
Effects of a Group Residential Retreat on Cancer Outcomes
NCT02429544CI-TRIAL-00023302withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is unfunded and lack of resources
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electroencephalogram (EEG) | Device | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Residential Program | Behavioral | — | UNRESOLVED |
| Saliva Testing | Other | — | UNRESOLVED |
| Study Diary plus Actigraph | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Experimental Support Group (ESG) - Residential Program
- description
- 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.
- interventionNames
- Behavioral: Residential Program
- Behavioral: Questionnaires
- Device: Electroencephalogram (EEG)
- Other: Saliva Testing
- Behavioral: Study Diary plus Actigraph
- type
- EXPERIMENTAL
- label
- Standard Support Group (SSG) - Residential Program
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 50 and over initially diagnosed with breast cancer by histological tissue diagnosis in 2003 or later. 2. Currently Stage IV (metastatic) breast cancer on the basis of definitive imaging or biopsy with stable disease (scans within the past 2 months). 3. ECOG (Eastern Cooperative Group) Performance Score of 0 or 1. 4. Able to participate occasionally in mildly strenuous physical effort. 5. Able to read, speak, and write in English or ability to provide consent or understand questionnaires. 6. Able to be accompanied by their spouse or significant other partner/friend (spouse, significant other, partner, or friend. 7. Able to travel to the retreat site. 8. Must be right handed. 9. 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. 10. (CAREGIVERS ONLY) Must be primary caregiver of the patient. 11. (CAREGIVERS ONLY) Able to read, speak, and write in English. 12. (CAREGIVERS ONLY) Able to attend the last two days of the retreat with patient. Exclusion Criteria: 1. 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. 2. Evidence of disease progression that would necessitate a treatment in the next 2 weeks. 3. Need for intravenous therapy more frequently than every 3 weeks or inability to time intravenous therapy treatment before and after the study. 4. Currently in treatment for a major psychiatric disorder 5. Clinical history of severe psychiatric disorders. 6. Currently receiving chemotherapy. 7. (CAREGIVERS ONLY) Must be an adult (\>=18 years old).
References
Publications (0)
Data not yet available
No reference posted for this study.