Trial of Family Focused Grief Therapy in Palliative Care and Bereavement - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) Beth Israel Medical Center Calvary Hospital New York Visiting Nurse Service Hospice Program
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00580515

Purpose

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.

Condition	Intervention
Cancer	Behavioral: Family Focused Group Therapy Behavioral: No intervention

MedlinePlus related topics: Bereavement Cancer Palliative Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 6 sessions of Family Focused Group Therapy	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.
2: Experimental 10 Sessions of Family Focused Group Therapy	Behavioral: 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
3: No Intervention Standard Care- Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request	Behavioral: No intervention Standard of Care

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 care program), The Visiting Nursing Service of New York, and Beth Israel Hospice Service (which runs a community-based hospice home-care program). 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

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject/Patient Inclusion Criteria

Individuals with advanced disease/Stage 4 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580515

Contacts

Contact: David Kissane, MD

kissaned@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: David Kissane, MD kissaned@mskcc.org
Calvary Hospital	Recruiting
Bronx, New York, United States, 10461
Contact: Robert Brescia, MD
New York Visiting Nurse Service Hospice Program	Recruiting
New York, New York, United States, 10065
Contact: Jeanne Dennis, PhD
Beth Israel Hospice Program	Recruiting
New York, New York, United States, 10003
Contact: Wayne Ury, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Beth Israel Medical Center

Calvary Hospital

New York Visiting Nurse Service Hospice Program

Investigators

Principal Investigator:

David Kissane, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( David Kissane, MD )
Study ID Numbers:	05-120, CA115329
Study First Received:	December 20, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00580515 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Cancer
Randomized Controlled Trial
Family Therapy intervention

ClinicalTrials.gov processed this record on May 07, 2009