NCT01652768

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Brain Tumors

Interventions

Type	Name	Description
OTHER	Research Questionnaires	Hospital Anxiety and Depression Scale Pearlin \& Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey
OTHER	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
OTHER	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.
OTHER	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
OTHER	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
OTHER	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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-07-30
• Last updated: 2013-08-29

Locations

1 site across 1 country: United States