Family Therapy for Cancer Palliative Care and Bereavement

Recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Non-English, Under 12, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6-10 sessions over several weeks

700 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on family therapy and does not mention medication changes.

What data supports the effectiveness of the treatment Family Focused Group Therapy in cancer palliative care and bereavement?

Family Focused Grief Therapy (FFGT) has been shown to help families improve communication, cohesiveness, and conflict management, which can reduce the negative effects of grief. Studies indicate that FFGT is effective in aiding families at high risk of poor functioning during palliative care and bereavement, leading to better family functioning and reduced distress. ^{1 2 3 4 5}

Is Family Therapy for Cancer Palliative Care and Bereavement safe for humans?

Family Focused Grief Therapy (FFGT) has been studied in palliative care settings and is generally considered safe. It aims to help families manage grief and improve communication, with no reported safety concerns in the available research. ^{1 2 3 6 7}

How is Family Focused Group Therapy different from other treatments for cancer palliative care and bereavement?

Family Focused Group Therapy is unique because it targets the entire family rather than just the individual, aiming to improve family communication and functioning during palliative care and into bereavement. It is a structured, time-limited intervention that helps families at high risk of poor psychosocial outcomes by promoting cohesiveness and managing conflicts, which is not typically the focus of other treatments. ^{1 2 3 5 6}

Research Team

Talia Zaider, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for families with a member facing advanced cancer. Eligible participants include those with satisfactory cognitive function to consent and participate in therapy, at least two family members willing to join, and certain scores on a family relationship index. Families must speak English and be geographically able to attend sessions. Children under 12 or individuals with significant psychiatric issues are excluded.

Inclusion Criteria

I have stage 4 cancer and may be receiving care to ease symptoms.

Individuals with a poor prognosis Patient and Family Member

My family has at least 2 members, including me, ready to participate.

Exclusion Criteria

Geographical inaccessibility for patient and family member to attend family sessions

Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention

My child is under 12 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Family Focused Grief Therapy sessions are conducted with families of patients with advanced disease

6-10 sessions over several weeks

6 or 10 sessions (in-person)

Bereavement Follow-up

Follow-up of family members for psychosocial well-being, perceptions of family functioning, and costs of health-related care

13 months

Assessments at 3, 6, 9, and 13 months

Treatment Details

Interventions

• Family Focused Group Therapy
• Standard of Care

Trial Overview The study tests the effectiveness of Family Focused Grief Therapy during palliative care and after death. It compares standard care against family therapy in either 6 or 10 sessions, randomly assigning patients into these groups to see which helps more with communication and support.

Participant Groups

Group I: 2 Experimental Treatment 1 Intervention

10 Sessions of Family Focused Group Therapy

Group II: 1 Experimental Treatment 1 Intervention

6 sessions of Family Focused Group Therapy

Group III: 3 Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Beth Israel Medical Center

Collaborator

Trials

71

Recruited

8,500+

Calvary Hospital, Bronx, NY

Collaborator

Trials

13

Recruited

1,500+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Family focused grief therapy: a randomized, controlled trial in palliative care and bereavement. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Challenges in providing family-centered support to families in palliative care. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Family focused grief therapy: a versatile intervention in palliative care and bereavement. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

What works for therapists conducting family meetings: treatment integrity in family-focused grief therapy during palliative care and bereavement. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Psychosocial morbidity associated with patterns of family functioning in palliative care: baseline data from the Family Focused Grief Therapy controlled trial. [2017]

6. Germany pubmed.ncbi.nlm.nih.gov

[Family Focused Grief Therapy - A Suitable Model for the Palliative Care of Cancer Patients and their Families?]. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Family care before and after bereavement. [2019]