CancerNCT00580515
Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
A study testing Family Focused Group Therapy in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Family Focused Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Nov 2005to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Hospice Program
New York, New York, 10003
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Calvary Hospital
The Bronx, New York, 10461
About this study
Official title: Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
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.
Read the 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 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.
- Conditions
- Cancer
- Being tested
- Family Focused Group Therapy, Standard of Care
- Keywords
- Cancer, Randomized Controlled Trial, Family Therapy intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Focused Group TherapyBehavioural
Also called FFGT
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.
Family Focused Group TherapyBehavioural
Also called FFGT
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
Standard of CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6 sessions of Family Focused Group Therapy Receives: Behavioral: Family Focused Group Therapy |
| 2 | Experimental | 10 Sessions of Family Focused Group Therapy Receives: 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 Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start8 Nov 2005
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Beth Israel Medical Center, Calvary Hospital, Bronx, NY, Monash University
- Responsible party
- Sponsor
- Investigators
- Talia Zaider, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580515
- Sponsor's protocol ID
- 05-120
- Other IDs
- CA115329
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2007
- Last updated
- 13 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Family Focused Grief Therapy in Palliative Care and Bereavement
- ClinicalTrials.gov ID
- NCT00580515
- Acronym / sponsor ID
- 05-120
- Conditions
- Cancer
- Keywords
- Cancer, Randomized Controlled Trial, Family Therapy intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Beth Israel Medical Center, Calvary Hospital, Bronx, NY, Monash University
- Study start
- 8 Nov 2005 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Family Focused Group Therapy6 sessions of Family Focused Group Therapy |
| 2 | Experimental | Behavioral: Family Focused Group Therapy10 Sessions of Family Focused Group Therapy |
| 3 | Active comparator | Behavioral: Standard of CareStandard Care- Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Focused Group TherapyAlso: FFGT6 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. | Behavioural | 1, 2 |
| Family Focused Group TherapyAlso: FFGT10 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 | Behavioural | 1, 2 |
| Standard of CareStandard 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. | Behavioural | 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Memorial Sloan-Kettering web siteLink provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talia Zaider, PhD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Focused Group Therapy in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.