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

NCT ID: NCT07105033

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2029-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Examine Initial Acceptability and Efficacy Signal of FACT

Potential participants will be identified weekly via MDACC's computerized appointment system for the Supportive Care Outpatient Clinic.

Group Type: EXPERIMENTAL

FACT Session

Intervention Type: BEHAVIORAL

Participants will participate in 4 weekly, 35-45 minute sessions

Controlled Trial (RCT) to Examine Feasibility, Acceptability and Initially Efficacy of FACT

Potential participants will be identified weekly via MDACC's computerized appointment system for the Supportive Care Outpatient Clinic.

Group Type: EXPERIMENTAL

Enhanced Usual Care and Assessments

Intervention Type: BEHAVIORAL

Participants will complete a symptoms questionnaire

Interventions

FACT Session

Participants will participate in 4 weekly, 35-45 minute sessions

Intervention Type: BEHAVIORAL

Enhanced Usual Care and Assessments

Participants will complete a symptoms questionnaire

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliet Kroll, BA,PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Juliet Kroll, BA,PHD

Role: CONTACT

jlkroll@mdanderson.org

(346) 723-5858

Facility Contacts

Juliet Kroll, BA,PHD

Role: primary

jlkroll@mdanderson.org

346-723-5858

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2025-05620

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0481

Identifier Type: -

Identifier Source: org_study_id