- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00580515
Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
The purpose of this study is to learn how well family therapy works if given while a family member is being treated for a serious illness and whether it helps their family to continue meeting for a time after their death. The therapy aims to assist the family communication and support during both palliative care and bereavement. The investigators also want to learn how many family therapy sessions spread out over time are best for helping patients and their families.
Patients are randomly assigned to one of three groups: patients who receive standard palliative care, patients and their families who take part in 6 sessions, and patients and their families who take part in 10 sessions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Calvary Hospital
-
New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, United States, 10003
- Beth Israel Hospice Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Subject/Patient Inclusion Criteria
- Individuals with advanced disease/Stage 4-IV cancer who may be involved in palliative care treatment program.
- Individuals with a poor prognosis Patient and Family Member Inclusion Criteria.
- Per investigator's judgment participants must have satisfactory cognitive functioning to provide valid informed consent and participate in family therapy.
- In the event that the index family member is declining or too frail to take part in family meetings, the family is able to participate without the index patient being involved in the study.
- For every enrolled family there must be at least 2 family members willing/able to take part at the time of recruitment.
- The presence of FRI screening scores of ≤ 9 or cohesiveness subscale score < 4 based on the perception of any single family member, including the patient.
Exclusion Criteria:
- Inability through language to complete the study questionnaires - inability to speak English with an English-speaking therapist.
- Age less than 12 years old for a child.
- Patient and family member determined geographical inaccessibility to attend family sessions.
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
6 sessions of Family Focused Group Therapy
|
6 Sessions of Family Focused Group Therapy (FFGT).
The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases.
The first two sessions are assessment sessions and occur one week apart.
There will be two or six focused intervention sessions depending on the predetermined length of therapy.
The first focused intervention session is approximately two weeks after the last assessment session.
Subsequent focused intervention sessions are expected to follow once every month.
Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart.
The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months.
Other Names:
10 Sessions of Family Focused Group Therapy (FFGT).
The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases.
The first two sessions are assessment sessions and occur one week apart.
There will be two or six focused intervention sessions depending on the predetermined length of therapy.
The first focused intervention session is approximately two weeks after the last assessment session.
Subsequent focused intervention sessions are expected to follow once every month.
Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart.
The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months
Other Names:
|
Experimental: 2
10 Sessions of Family Focused Group Therapy
|
6 Sessions of Family Focused Group Therapy (FFGT).
The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases.
The first two sessions are assessment sessions and occur one week apart.
There will be two or six focused intervention sessions depending on the predetermined length of therapy.
The first focused intervention session is approximately two weeks after the last assessment session.
Subsequent focused intervention sessions are expected to follow once every month.
Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart.
The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months.
Other Names:
10 Sessions of Family Focused Group Therapy (FFGT).
The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases.
The first two sessions are assessment sessions and occur one week apart.
There will be two or six focused intervention sessions depending on the predetermined length of therapy.
The first focused intervention session is approximately two weeks after the last assessment session.
Subsequent focused intervention sessions are expected to follow once every month.
Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart.
The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months
Other Names:
|
Active Comparator: 3
Standard Care- Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request
|
Standard of Care Families assigned to the Usual Care Condition will receive standard psychosocial care which is based on the following patterns: Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the efficacy and dose responsiveness of family intervention in preventing bereavement and depression compared with standard palliative care among family members and to examine whether distress moderates impact of FFGT
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate whether family coping and communication mediate the impact of FFGT and examine costs of FFGT and standard palliative care, and whether the additional costs are offset by reductions in community health utilization
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Talia Zaider, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 05-120
- CA115329
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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