View Clinical Trial (Medical Research Study)
PRESENCE Project: An Early Palliative Care Intervention for Patients With Malignant Brain Tumors and Their Primary Caregivers
| City: |
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Cleveland |
| State: |
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Ohio |
| Zip Code: |
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44106 |
| Conditions: |
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Malignant Brain Tumors |
| Purpose: |
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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.
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| Study Summary: |
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Patients and caregivers will be enrolled in two phases. Phase I is a qualitative study
exploring the experience of primary caregivers of patients with a new diagnosis of malignant
brain tumor during the first 10 weeks of the diagnosis and beginning treatment process.
During Phase I, only caregivers patients with a malignant brain tumor who are at least two
months and not more than six months into treatment at the Seidman Cancer Center (SCC)will be
enrolled. They will be asked to participate in a qualitative interview to describe the newly
diagnosed experience (diagnosis through first 10 weeks of treatment) of having a loved one
with a malignant brain tumor.
A convenience sample of 20 patients and their primary caregivers will be enrolled for Phase
II of this pilot project. The first ten patients and caregivers enrolled will receive usual
care (Phase II, Arm A). 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 second ten patients and caregivers enrolled will receiving the intervention (Phase II,
Arm B). 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. 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.
RESEARCH OBJECTIVES:
1. To investigate the feasibility of an early palliative care intervention (PRESENCE:
Providing Resources Education, Support, and Enabling New brain tumor patients to Cope
Effectively) for patients newly diagnosed with a malignant brain tumor and their
primary caregivers.
2. To explore the experience of being a caregiver of a patient newly diagnosed with a
malignant brain tumor.
3. To determine the effect of the PRESENCE Intervention on patient and caregiver distress,
anxiety, and depression.
4. To determine the effect of the PRESENCE Intervention on caregiver reaction (benefit and
burden) and caregiver mastery.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01652768 |
| Primary Contact: |
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Principal Investigator
Polly Mazanec, PhD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cleveland, Ohio 44106
United States
Polly Mazanec, PhD
Phone: 216-368-4788
Email: polly.mazanec@case.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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