Recruiting

FACT

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07105033

Conditions

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FACT Session

Enhanced Usual Care and Assessments

Study Details

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

Study ID

NCT07105033

Start date

Jul 21, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

FACT Session

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

Enhanced Usual Care and Assessments

Participants will complete a symptoms questionnaire

Primary outcome measure

  • 1. Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Juliet Kroll, BA,PHD

(346) 723-5858jlkroll@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Juliet Kroll, BA,PHD

346-723-5858jlkroll@mdanderson.org

Principal Investigator:

Juliet Kroll, BA,PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-02.