PRESENCE Project: An Early Palliative Care Intervention in Brain Tumors
NCT ID: NCT01652768
Last Updated: 2013-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2011-12-31
2013-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A: Usual Care Group
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.
Research Questionnaires
Hospital Anxiety and Depression Scale Pearlin \& Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey
Arm B: PRESENCE Intervention
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.
Educational Information Session for Patients and Caregivers
Provide an educational class "Moving Forward: Facing a Brain Tumor Diagnosis" for patient and caregiver Week 5 through 7: The PRESENCE Project Social Worker and oncology RN will provide an educational class.
Intervention (Length of time for class = 2 hours):
1. Provide an educational class "Moving Forward: Facing a Brain Tumor Diagnosis" for patient and caregiver.
2. Provide additional resources/referrals for any needs that are identified by patient or care partner during the educational class.
3. Provide supportive care.
Research Questionnaires
Hospital Anxiety and Depression Scale Pearlin \& Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey
Palliative Care Team
Week 1: 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).
1. Introduce the palliative care team concept.
2. Provide contact information for the palliative care team given
3. Administer Initial Patient and Caregiver Psychosocial Assessments (Appendix A)
4. Offer community resources to patient and caregiver (Appendix B)
5. Provide additional resources/referrals for any needs that are identified by patient or care partner during initial psychosocial assessment
6. Provide supportive care
Contact every 2 weeks
The PRESENCE Project APN and/or Presence Project Social Worker will contact the patient and caregiver via telephone or office visit every two weeks and as needed until the second medical oncology visit.
(Anticipated length of time for phone intervention or visit is 20 minutes; however, length of time for intervention is tailored to the patient and caregiver's needs):
1. Administer Patient and Caregiver Follow-up Assessment
2. Provide pain and/or symptom management intervention for any issues identified during the follow-up assessment
3. Provide resources/referrals for any needs identified during the social work follow-up assessment
4. Provide supportive care
Follow-up Surgical Visit Session
The PRESENCE Project APN will meet with patient and caregiver at the surgical follow-up visit, approximately two weeks after surgery.
Intervention (Anticipated length of time for visit is about 30 minutes; however length of time for intervention is tailored to the patient and caregiver's needs):
1. Administer Patient and Caregiver Follow-up Assessment
2. Administer Symptom Assessment Tool
3. Provide pain and/or symptom management intervention
4. Provide supportive care
Medical and/or Radiation Oncology Appointment Session
The PRESENCE Project APN and/or Presence Project Social Worker will meet with patient and caregiver at the first medical and/or radiation oncology appointment (weeks 3 and 4).
Intervention (Anticipated length of time for visit is about 30 minutes; however length of time for intervention is tailored to the patient and caregiver's needs):
1. Administer Patient and Caregiver Follow-up Assessment
2. Re-assess pain and/or symptom management issues and /or intervention
3. Provide resources/referrals for any needs identified during the social work follow-up assessment
4. Provide supportive care.
Interventions
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Educational Information Session for Patients and Caregivers
Provide an educational class "Moving Forward: Facing a Brain Tumor Diagnosis" for patient and caregiver Week 5 through 7: The PRESENCE Project Social Worker and oncology RN will provide an educational class.
Intervention (Length of time for class = 2 hours):
1. Provide an educational class "Moving Forward: Facing a Brain Tumor Diagnosis" for patient and caregiver.
2. Provide additional resources/referrals for any needs that are identified by patient or care partner during the educational class.
3. Provide supportive care.
Research Questionnaires
Hospital Anxiety and Depression Scale Pearlin \& Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey
Palliative Care Team
Week 1: 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).
1. Introduce the palliative care team concept.
2. Provide contact information for the palliative care team given
3. Administer Initial Patient and Caregiver Psychosocial Assessments (Appendix A)
4. Offer community resources to patient and caregiver (Appendix B)
5. Provide additional resources/referrals for any needs that are identified by patient or care partner during initial psychosocial assessment
6. Provide supportive care
Contact every 2 weeks
The PRESENCE Project APN and/or Presence Project Social Worker will contact the patient and caregiver via telephone or office visit every two weeks and as needed until the second medical oncology visit.
(Anticipated length of time for phone intervention or visit is 20 minutes; however, length of time for intervention is tailored to the patient and caregiver's needs):
1. Administer Patient and Caregiver Follow-up Assessment
2. Provide pain and/or symptom management intervention for any issues identified during the follow-up assessment
3. Provide resources/referrals for any needs identified during the social work follow-up assessment
4. Provide supportive care
Follow-up Surgical Visit Session
The PRESENCE Project APN will meet with patient and caregiver at the surgical follow-up visit, approximately two weeks after surgery.
Intervention (Anticipated length of time for visit is about 30 minutes; however length of time for intervention is tailored to the patient and caregiver's needs):
1. Administer Patient and Caregiver Follow-up Assessment
2. Administer Symptom Assessment Tool
3. Provide pain and/or symptom management intervention
4. Provide supportive care
Medical and/or Radiation Oncology Appointment Session
The PRESENCE Project APN and/or Presence Project Social Worker will meet with patient and caregiver at the first medical and/or radiation oncology appointment (weeks 3 and 4).
Intervention (Anticipated length of time for visit is about 30 minutes; however length of time for intervention is tailored to the patient and caregiver's needs):
1. Administer Patient and Caregiver Follow-up Assessment
2. Re-assess pain and/or symptom management issues and /or intervention
3. Provide resources/referrals for any needs identified during the social work follow-up assessment
4. Provide supportive care.
Eligibility Criteria
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Inclusion Criteria
* were involved in caregiving during the first ten weeks following diagnosis at the SCC
* are capable of providing informed consent.
* 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
\- 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.
18 Years
ALL
Yes
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Polly Mazanec, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE1310
Identifier Type: -
Identifier Source: org_study_id