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PRESENCE Project: An Early Palliative Care Intervention for Patients With Malignant Brain Tumors and Their Primary Caregivers


N/A
18 Years
N/A
Open (Enrolling)
Both
Malignant Brain Tumors

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Trial Information

PRESENCE Project: An Early Palliative Care Intervention for Patients With Malignant Brain Tumors and Their Primary Caregivers


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Feasibility of the intervention will be measured by participant surveys.

Outcome Description:

Using the patient satisfaction tool, the researchers will report descriptive data on patient and caregiver satisfaction with the intervention and any burden associated with participating in the intervention. In addition, the ability to contact patients and caregivers on an every two week basis, patient and caregiver attendance at the educational program, and evaluations from the Moving Forward program will be tracked.

Outcome Time Frame:

10 weeks

Safety Issue:

No

Principal Investigator

Polly Mazanec, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE1310

NCT ID:

NCT01652768

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Malignant Brain Tumors
  • Malignant Brain Tumors
  • Malignant Glioma
  • High-grade Gliomas
  • Oncology
  • Cancer
  • Patient Caregiver
  • Caregiver Stress, Anxiety, Depression
  • Palliative Care Intervention
  • Brain Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065