Cancer Clinical Trial - Trial of Family Focused Grief Therapy in

Status Active, not recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT00580515
Study type	Interventional
Source	Memorial Sloan Kettering Cancer Center
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 2005
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Trial of Family Focused Grief Therapy in Palliative Care and Bereavement

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms