Clinical trial NCT01652768: PRESENCE Project: An Early Palliative Care Intervention in Brain Tumors
Official title: PRESENCE Project: An Early Palliative Care Intervention for Patients With Malignant Brain Tumors and Their Primary Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Brain Tumors
Keywords: Malignant Brain Tumors
Malignant Glioma
High-grade Gliomas
Oncology
Cancer
Patient Caregiver
Caregiver Stress, Anxiety, Depression
Palliative Care Intervention
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of the intervention will be measured by participant surveys.
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in distress level
timeFrame: 10 weeks
measure: Change in Anxiety level
timeFrame: 10 weeks
measure: Change in Depression level
timeFrame: 10 weeks
measure: Caregiver Response to the Caregiving Experience
timeFrame: 10 weeks
measure: Caregiver Mastery
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Polly Mazanec, PhD
role: PRINCIPAL_INVESTIGATOR
References: