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

NCT07105033 | Recruiting

• 2 other identifiers: 2025-0481NCI-2025-05620
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 1. Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (2)

Examine Initial Acceptability and Efficacy Signal of FACT

EXPERIMENTAL

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

Behavioral: FACT Session

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

EXPERIMENTAL

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

Behavioral: Enhanced Usual Care and Assessments

Interventions

FACT Session BEHAVIORAL

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

Examine Initial Acceptability and Efficacy Signal of FACT

Enhanced Usual Care and Assessments BEHAVIORAL

Participants will complete a symptoms questionnaire

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

Study Officials

• Juliet Kroll, BA,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliet Kroll, BA,PHD

CONTACT

(346) 723-5858; jlkroll@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)