Trial of Family Focused Grief Therapy in Palliative Care and Bereavement

NCT00580515 | Completed

• 2 other identifiers: 05-120CA115329
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Cancer; Randomized Controlled Trial; Family Therapy intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

EXPERIMENTAL

6 sessions of Family Focused Group Therapy

Behavioral: Family Focused Group Therapy

2

EXPERIMENTAL

10 Sessions of Family Focused Group Therapy

Behavioral: Family Focused Group Therapy

3

ACTIVE COMPARATOR

Standard Care- Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request

Behavioral: Standard of Care

Interventions

Standard of Care BEHAVIORAL

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.

3

Family Focused Group Therapy BEHAVIORAL

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.

Also known as: FFGT

1; 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with advanced disease/Stage 4-IV cancer who may be involved in palliative care treatment program.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Beth Israel Medical Center: collaborator
• Calvary Hospital, Bronx, NY: collaborator
• Monash University: collaborator

Study Sites (3)

Beth Israel Hospice Program

New York, New York, 10003, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Calvary Hospital

The Bronx, New York, 10461, United States

Location

Related Links

• Memorial Sloan-Kettering web site

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Talia Zaider, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: November 8, 2005
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (3)