Trial of Family Focused Grief Therapy in Palliative Care and Bereavement

Cancer Clinical Trial

Official title:

Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00580515
• Other study ID #: 05-120
• Secondary ID: CA115329
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2005
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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.
• Family Focused Group Therapy
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
• Standard of Care
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.

Locations

Country	Name	City	State
United States	Calvary Hospital	Bronx	New York
United States	Beth Israel Hospice Program	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Beth Israel Medical Center, Calvary Hospital, Bronx, NY, Monash University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 years
Secondary	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		5 years

External Links

•   Memorial Sloan-Kettering web site