Focused Acceptance and Commitment Therapy (FACT) for people with advanced cancer
Development and Pilot Trial of Focused ACT (FACT) for Patients With Advanced Cancer
This program will try a short therapy called Focused Acceptance and Commitment Therapy (FACT) to see if it reduces worries about dying in people with advanced cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07105033 on ClinicalTrials.gov |
What this trial studies
This pilot interventional program delivers a brief, manualized Acceptance and Commitment Therapy (FACT) intervention to patients with advanced cancer to target death-related anxiety. Phase 1 is a single-arm pilot estimating feasibility and acceptability using metrics such as intervention fidelity, session attendance, retention, and participant satisfaction; Phase 2 moves toward a pilot randomized comparison including enhanced usual care. Outcomes are measured with validated self-report scales (DADDS for death anxiety, CFQ for cognitive fusion, GAD-7, CES-D, QUAL-E, and others) at baseline, post-treatment, and six-week follow-up. Sessions are delivered in person or via an institution-approved Zoom platform and include structured assessments and coping skills practice.
Who should consider this trial
Good fit: Adults with advanced solid tumor or hematologic cancer who have progressed after at least one line of palliative systemic therapy, report moderate death anxiety (DADDS ≥25), are followed by the Supportive Care Outpatient Service, speak English, can consent, and have access to Zoom-capable technology.
Not a fit: Patients with poor functional status (ECOG ≥3), active suicidal ideation or need for a higher level of care, those already in regular psychotherapy, patients with documented out-of-hospital DNR orders, or those without access to required technology are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, FACT could reduce death-related anxiety and improve coping and quality of life for people with advanced cancer.
How similar studies have performed: ACT-based therapies have shown benefits for distress and coping in cancer populations, but this focused FACT program specifically targeting death anxiety is relatively novel and has limited prior trial data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult cancer patients diagnosed with advanced cancer (solid tumor and hematologic) * Progressed past at least one line of palliative systemic cancer therapy * Patient followed by Supportive Care Outpatient Service * English speaking * Able to provide written informed consent * Willing to participate in a stress and coping program * Willing to identify 1-2 important areas of life they might like to discuss with a counselor * Moderate levels of death anxiety on DADDS (\>=25, on 0-75 scale) * Access to technology to support institutionally approved video-conferencing platform of Zoom Exclusion Criteria: * ECOG performance status \>=3 "capable of only limited selfcare; confined to bed or chair more than 50% of waking hours" * Currently participating in regular psychotherapy (patient defined) * Documented out of hospital DNR (do not resuscitate) orders * Presence of active suicidal ideation or need for a higher level of care (as determined by Supportive Care physician or licensed mental health clinician).
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Juliet Kroll, BA,PHD — M.D. Anderson Cancer Center
- Study coordinator: Juliet Kroll, BA,PHD
- Email: jlkroll@mdanderson.org
- Phone: (346) 723-5858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.