Clinical trial NCT00580515: Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
Official title: Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Randomized Controlled Trial
Family Therapy intervention
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Beth Israel Medical Center
name: Calvary Hospital, Bronx, NY
name: Monash University
First posted: 2007-12-24
Enrollment: 700
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Calvary Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Hospice Program
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Talia Zaider, PhD
role: PRINCIPAL_INVESTIGATOR
References: