Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 5
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
6 sessions of Family Focused Group Therapy
干预措施: Family Focused Group Therapy (Behavioral)
2
10 Sessions of Family Focused Group Therapy
干预措施: Family Focused Group Therapy (Behavioral)
3
Standard Care- Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
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
时间窗: 5 years
次要结局
- 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)