PRESENCE Project: An Early Palliative Care Intervention in Brain Tumors

Malignant Brain Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01652768
• Other study ID #: CASE1310
• Status: Terminated
• Phase: N/A
• First received: July 26, 2012
• Last updated: August 28, 2013
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Malignant Brain Tumors

Intervention

Other:
• 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). Introduce the palliative care team concept. Provide contact information for the palliative care team given Administer Initial Patient and Caregiver Psychosocial Assessments (Appendix A) Offer community resources to patient and caregiver (Appendix B) Provide additional resources/referrals for any needs that are identified by patient or care partner during initial psychosocial assessment Provide supportive care
• 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): Provide an educational class "Moving Forward: Facing a Brain Tumor Diagnosis" for patient and caregiver. Provide additional resources/referrals for any needs that are identified by patient or care partner during the educational class. 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): Administer Patient and Caregiver Follow-up Assessment Provide pain and/or symptom management intervention for any issues identified during the follow-up assessment Provide resources/referrals for any needs identified during the social work follow-up assessment 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): Administer Patient and Caregiver Follow-up Assessment Administer Symptom Assessment Tool Provide pain and/or symptom management intervention 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): Administer Patient and Caregiver Follow-up Assessment Re-assess pain and/or symptom management issues and /or intervention Provide resources/referrals for any needs identified during the social work follow-up assessment Provide supportive care.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in distress level	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	No
Secondary	Change in Anxiety level	Distress: Psychological distress is defined as "the general concept of maladaptive psychological functioning in the face of stressful life events" (Abeloff et al., 2000, p. 556). Distress is being measured as a global construct, using a distress thermometer as described by the National Comprehensive Cancer Network (NCCN) Guidelines (Holland & Alici, 2010; nccn.org). Participants will rate their present level of distress (on a 0-10 scale, with 0 being no distress, to 10 being the most distressed) and then identify particular stressors in the area of practical problems, family problems, emotional problems, spiritual/religious concerns, physical problems, and any additional stressor as identified by the participant.	10 weeks	No
Secondary	Change in Depression level	Anxiety and depression are two psychological outcomes commonly reported in caregiving research. The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983) will be used to measure both concepts reflective of psychological wellbeing in patients and caregivers. The HADS is a reliable and valid instrument, with strong internal consistency for cancer populations. It has been used for patients who are hospitalized or ambulatory patients and for caregivers. It consists of 14 items which are scored on a four-point Likert scale (0-3). Items are recoded and summarized into subscales of anxiety and depression (range 0-21). Participants scoring 11 or higher are considered anxious or depressed.	10 weeks	No
Secondary	Caregiver Response to the Caregiving Experience	The reaction is either positive (caregiver benefit) or negative (caregiver burden). The caregiver reaction will be assessed using the Caregiver Reaction Assessment (CRA). This 24-item instrument will be used to measure the burden of informal caregiving using a 5-point Likert scale. The CRA consists of five subscales that represent positive and negative burden aspects of caregiving. They include 1) impact on schedule; 2) caregiver's esteem; 3) lack of family support; 4) impact on health; and 5) impact on finances. Positive items are reversed scored. Higher scores indicate greater levels of perceived burden.	10 weeks	No
Secondary	Caregiver Mastery	The Pearlin & Schooler Mastery Instrument (1978) will be used to assess caregiver mastery. Caregiver mastery refers to the caregivers' perceptions of their ability to meet the challenges of caregiving, to feel in control of the situation, and to use effective problem solving skills. The Pearlin & Schooler Master Instrument is a seven item, five-point Likert scale instrument with a Crohnbach's alpha = 0.73. Scoring is done by summing item scores for a total score (possible range 7-35) with higher scores indicating higher levels of mastery. Examples of items include, "I have little control over the things that happen to me", and "There is little I can do to change many of the important things in my life".	10 weeks	No