Trial of Family Focused Grief Therapy in Palliative Care and Bereavement (NCT00580515) | Clinical Trial Compass
CompletedNot Applicable
Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
United States700 participantsStarted 2005-11-08
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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