PRESENCE Project: An Early Palliative Care Intervention in Brain Tumors

NCT01652768 | Terminated

• 1 other identifier: CASE1310
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Brain Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of the intervention will be measured by participant surveys.

  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.

  10 weeks

Secondary Outcomes (5)

• Change in distress level

  10 weeks

• Change in Anxiety level

  10 weeks

• Change in Depression level

  10 weeks

• Caregiver Response to the Caregiving Experience

  10 weeks

• Caregiver Mastery

  10 weeks

Study Arms (2)

Arm A: Usual Care Group

ACTIVE COMPARATOR

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.

Other: Research Questionnaires

Arm B: PRESENCE Intervention

EXPERIMENTAL

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.

Other: Research Questionnaires; Other: Palliative Care Team; Other: Educational Information Session for Patients and Caregivers; Other: Contact every 2 weeks; Other: Follow-up Surgical Visit Session; Other: Medical and/or Radiation Oncology Appointment Session

Interventions

Research Questionnaires OTHER

Hospital Anxiety and Depression Scale Pearlin \& Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey

Arm A: Usual Care Group; Arm B: PRESENCE Intervention

Palliative Care Team OTHER

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

Arm B: PRESENCE Intervention

Educational Information Session for Patients and Caregivers OTHER

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.

Arm B: PRESENCE Intervention

Contact every 2 weeks OTHER

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

Arm B: PRESENCE Intervention

Follow-up Surgical Visit Session OTHER

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

Arm B: PRESENCE Intervention

Medical and/or Radiation Oncology Appointment Session OTHER

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.

Arm B: PRESENCE Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.
• 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.
• \- 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Glioma; Neoplasms; Caregiver Burden; Anxiety Disorders; Depression

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Polly Mazanec, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

US (1)