Malignant Brain TumorsNCT01652768

PRESENCE Project: An Early Palliative Care Intervention in Brain Tumors

A study testing Research Questionnaires, Palliative Care Team and Educational Information Session for Patients and Caregivers in people with Malignant Brain Tumors, run by Case Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Malignant Brain Tumors
What is being tested?: Research Questionnaires, Palliative Care Team and Educational Information Session for Patients and Caregivers
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Aug 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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.

Who cannot join

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 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

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

Read the 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:

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.
To explore the experience of being a caregiver of a patient newly diagnosed with a malignant brain tumor.
To determine the effect of the PRESENCE Intervention on patient and caregiver distress, anxiety, and depression.
To determine the effect of the PRESENCE Intervention on caregiver reaction (benefit and burden) and caregiver mastery.

Conditions: Malignant Brain Tumors
Being tested: Research Questionnaires, Palliative Care Team, Educational Information Session for Patients and Caregivers, Contact every 2 weeks, Follow-up Surgical Visit Session
Keywords: Malignant Brain Tumors, Malignant Glioma, High-grade Gliomas, Oncology, Cancer, Patient Caregiver, Caregiver Stress, Anxiety, Depression, Palliative Care Intervention
Medical subject headings: Glioma, Neoplasms, Caregiver Burden, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Research QuestionnairesOther
Hospital Anxiety and Depression Scale Pearlin \& Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey
Palliative Care TeamOther
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
Educational Information Session for Patients and CaregiversOther
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.
Contact every 2 weeksOther
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
Follow-up Surgical Visit SessionOther
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
Medical and/or Radiation Oncology Appointment SessionOther
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.

Study groups in NCT01652768
Study group	Role	What they receive
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. Receives: 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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10 weeks

Secondary outcomes (5)

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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
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".
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Aug 2013

First posted30 Jul 2012 (estimated)
Study startDec 2011
Primary completionAug 2013
Study completionAug 2013

Why it stopped: Research Cancelled

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malignant Brain TumorsStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01652768
Sponsor's protocol ID: CASE1310
Status last verified: Aug 2013
First submitted: 26 Jul 2012
Last updated: 29 Aug 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Brain Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRESENCE Project: An Early Palliative Care Intervention for Patients With Malignant Brain Tumors and Their Primary Caregivers
ClinicalTrials.gov ID: NCT01652768
Acronym / sponsor ID: CASE1310
Conditions: Malignant Brain Tumors
Keywords: Malignant Brain Tumors, Malignant Glioma, High-grade Gliomas, Oncology, Cancer, Patient Caregiver, Caregiver Stress, Anxiety, Depression, Palliative Care Intervention
Study type: Interventional
Recruitment status: TerminatedReason stopped: Research Cancelled
Enrolment: 1 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Study start: Dec 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 30 Jul 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

RESEARCH OBJECTIVES:

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.
To explore the experience of being a caregiver of a patient newly diagnosed with a malignant brain tumor.
To determine the effect of the PRESENCE Intervention on patient and caregiver distress, anxiety, and depression.
To determine the effect of the PRESENCE Intervention on caregiver reaction (benefit and burden) and caregiver mastery.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Usual Care Group	Active comparator	Other: Research QuestionnairesUsual 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.
Arm B: PRESENCE Intervention	Experimental	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 SessionThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.
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

Key exclusion criteria (6 listed)

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 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Research QuestionnairesHospital Anxiety and Depression Scale Pearlin \& Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey	Other	Arm A: Usual Care Group, Arm B: PRESENCE Intervention
Palliative Care TeamWeek 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	Arm B: PRESENCE Intervention
Educational Information Session for Patients and CaregiversProvide 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	Arm B: PRESENCE Intervention
Contact every 2 weeksThe 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	Arm B: PRESENCE Intervention
Follow-up Surgical Visit SessionThe 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	Arm B: PRESENCE Intervention
Medical and/or Radiation Oncology Appointment SessionThe 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.	Other	Arm B: PRESENCE Intervention

Primary outcome

Feasibility of the intervention will be measured by participant surveys.
Time frame: 10 weeks
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.

5 secondary outcomes

Change in distress level
Time frame: 10 weeks
Change in Anxiety level
Time frame: 10 weeks
Change in Depression level
Time frame: 10 weeks
Caregiver Response to the Caregiving Experience
Time frame: 10 weeks
Caregiver Mastery
Time frame: 10 weeks

Results and safety

The study was stopped early (reason given: Research Cancelled). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Polly Mazanec, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Research Cancelled). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the intervention will be measured by participant surveys. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01652768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2013.