Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
12 Years
N/A
Both
Cancer
Trial Information
Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
This Randomized Controlled Trial (RCT) seeks to test the efficacy and dose responsiveness of
a manualized family therapy intervention called Family Focused Grief Therapy (FFGT), which
is delivered to families of patients with advanced disease and continued into bereavement.
Randomization is to three arms: 6 sessions of FFGT, 10 sessions of FFGT, or standard care.
The study also explores the potential mediators of effective outcome, empowering further
refinement of the intervention, and undertakes an analysis of health-related costs of
bereavement care. It is a multi-site study involving Memorial Hospital for Cancer and Allied
Diseases (a comprehensive cancer center), Calvary Hospital (a dedicated palliative care
hospital with home hospice care program)and Beth Israel (a medical center with a dedicated
pain and palliative care department. Consenting families will be assessed at baseline
through completion of questionnaires that appraise each individual's psychosocial well-being
and perception of their family's functioning. Therapy will be delivered by family therapists
(social workers, psychologists, and psychiatrists), who will attend regular supervision
sessions to sustain fidelity of the model of intervention. Follow-up of family members for
psychosocial well-being, perceptions of family functioning, and costs of heath-related care
will occur at 3, 6, 9, & 13 months after the patient's death or completion of therapy
sessions.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Talia Zaider, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
05-120
NCT ID:
NCT00580515
Start Date:
November 2005
Completion Date:
December 2012
Related Keywords:
- Cancer
- Cancer
- Randomized Controlled Trial
- Family Therapy intervention
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Calvary Hospital | Bronx, New York |
| Beth Israel Hospice Program | New York, New York 10003 |
