Clinical trial · Interventional
PRESENCE Project: An Early Palliative Care Intervention in Brain Tumors
PRESENCE Project: An Early Palliative Care Intervention for Patients With Malignant Brain Tumors and Their Primary Caregivers
NCT01652768CI-TRIAL-00011952terminatedN/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): Research Cancelled
Summary
Brief summary (as posted)
The purpose of this pilot study is to investigate the feasibility of an early palliative care intervention (PRESENCE: Providing Resources Education, Support, and Enabling New brain tumor patients to Cope Effectively) and the effect of the intervention on patient and caregiver distress.
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 |
|---|---|---|---|
| Malignant Brain Tumors | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contact every 2 weeks | Other | — | UNRESOLVED |
| Educational Information Session for Patients and Caregivers | Other | — | UNRESOLVED |
| Follow-up Surgical Visit Session | Other | — | UNRESOLVED |
| Medical and/or Radiation Oncology Appointment Session | Other | — | UNRESOLVED |
| Palliative Care Team | Other | — | UNRESOLVED |
| Research Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Usual Care Group
- description
- Usual care is defined as standard post-operative care on a surgical unit in University Hospitals Case Medical Center. Discharge planning will be provided by the assigned in-patient social worker. Referrals to the assigned outpatient social worker will be made as appropriate. Patients and caregivers will be seen in the ambulatory medical oncology setting about three to six weeks after surgery, depending on post-operative recovery time. The research assistant will administer the research questionnaires at week one post-surgery and 8-10 weeks post surgery.
- interventionNames
- Other: Research Questionnaires
- type
- EXPERIMENTAL
- label
- Arm B: PRESENCE Intervention
- description
- The unique features of the PRESENCE Project (PP) Intervention are 1) the early palliative care intervention (immediately post-op) provided by the new palliative care brain tumor team (Social worker, advanced practice nurse (APN), medical oncology registered nurse); 2) an educational information session for patients and caregivers; and 3) frequent (every two week and as needed) telephone or clinic visits during the first ten weeks post operatively (Figure 1). In usual care, the patient and caregiver receive little supportive care until they begin cancer treatment. The intervention provides aggressive supportive care from the time of diagnosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Caregivers (Phase I): * are identified by the patient and/or caregiver as the "primary caregiver" * were involved in caregiving during the first ten weeks following diagnosis at the SCC * are capable of providing informed consent. Exclusion Criteria for Caregivers (Phase I): \- include those whose are caring for patients who are in hospice or within 2 months of death, as this experience may influence their recollection of the diagnosis phase of the cancer trajectory. Inclusion Criteria for Patients (Phase II): * are newly diagnosed malignant brain tumor patients who are at University Hospitals and who are within a week of surgery * are receiving on-going care at the Seidman Cancer Center * are able to identify a primary caregiver involved in their care, support, and/or care planning * are capable of providing informed consent. Exclusion Criteria for Patients (Phase II): \- are those with a life expectancy of less than two months and/or those who are electing hospice care who will be receiving medical and or radiation oncology care outside of the Seidman Cancer Center. Eligibility criteria for caregivers (Phase II) * being identified by the patient as the "primary caregiver" * capable of providing informed consent. * Both the patient and caregiver must consent to be in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.