NCT07105033

Development and Pilot Trial of Focused ACT (FACT) for Patients With Advanced Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the effects of an intervention program called Focused Acceptance and Commitment Therapy (FACT) on the level of anxiety patients diagnosed with cancer feel about death. To learn if an intervention program called Focused Acceptance and Commitment Therapy (FACT), designed to help reduce death-related anxiety, is effective and acceptable to patients diagnosed with advanced cancer.

Detailed description

Primary Objectives: Phase 1 To estimate the initial feasibility and acceptability of delivering the iteratively developed FACT in a single-arm pilot trial. We hypothesize that FACT will be both feasible (defined criteria: ≥90% on intervention fidelity ratings, attendance of ≥70% of FACT sessions, retention post-intervention assessment completion 70%) and acceptable (defined criteria: patients will report average satisfaction as ≥4/5; average appropriateness of the intervention as ≥4/5; ≥75% would recommend FACT to others, and ≥50% indicate they are likely to use FACT strategies following sessions). Phase 2 To estimate initial within person change in self-report measures of death anxiety (DADDS) and cognitive fusion (CFQ) from baseline to post-treatment and 6-week follow-up assessment, in patients who participate in FACT intervention. Secondary Objectives: Phase 1 To estimate initial within person change in self-report measures of death anxiety (DADDS), death anxiety 2 item measure, cognitive fusion (CFQ), QOL (QUAL-E), anxiety (GAD-7), depression (CES-D), perceived stress (PSS), perceived social support (ISEL), illness understanding (Prigerson Illness Understanding Scale) and coping strategies (Brief COPE)) from baseline to post-treatment and 6-week follow-up assessment in patients who participate in FACT intervention in a single-arm pilot trial. Phase 2 To estimate feasibility and acceptability of FACT in a pilot RCT. We hypothesize that FACT will be both feasible (defined criteria: ≥90% on intervention fidelity ratings, attendance of ≥70% of FACT sessions, retention post-intervention assessment completion 70%) and acceptable (defined criteria: patients will report average satisfaction as ≥4/5; average appropriateness of the intervention as ≥4/5; ≥75% would recommend FACT to others, and ≥50% indicate they are likely to use FACT strategies following sessions). Phase 2 To estimate the initial within person change in self-report measures of QOL (QUAL-E), anxiety (GAD-7), depression (CES-D), perceived stress (PSS), perceived social support (ISEL), illness understanding (Prigerson Illness Understanding Scale) and coping strategies (Brief COPE)). Phase 2 To estimate between group differences in self-report measures of death anxiety (DADDS) and cognitive fusion (CFQ) in patients who participate in FACT intervention compared to a treatment as usual control group. We hypothesize that there will be an initial signal of a group by time effect, where those who participated in FACT report lower scores on DADDS and CFQ compared to those receiving treatment as usual at end-of-treatment and follow-up. Phase 2 To estimate between group differences in self-report measures of quality of life (QUAL-E), anxiety (GAD-7), depression (CES-D), perceived stress (PSS), perceived social support (ISEL-12), illness understanding (PUQ) and coping strategies (Brief COPE) for those who participated in FACT intervention compared to those receiving treatment as usual. Exploratory Objectives: Phase 2 To estimate between group differences in documented goals of care conversations (count) and aggressiveness of medical care within the last 30 days of life for patients after their death with measures defined by the National Quality Forum. Phase 1 and 2 To estimate between group differences and change over time in concept of double awareness (DAS) and how it may be associated with other self-report measures.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
BEHAVIORAL	FACT Session	Participants will participate in 4 weekly, 35-45 minute sessions
BEHAVIORAL	Enhanced Usual Care and Assessments	Participants will complete a symptoms questionnaire

Timeline

• Start date: 2025-07-21
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-08-05
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States