Advanced CancerNCT07105033
Development and Pilot Trial of Focused ACT (FACT) for Patients With Advanced Cancer
A study testing FACT Session in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- FACT Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Juliet Kroll, BA,PHD, 346-723-5858, jlkroll@mdanderson.org
Juliet Kroll, BA,PHD
About this study
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.
Read the 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
- Being tested
- FACT Session, Enhanced Usual Care and Assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACT SessionBehavioural
Participants will participate in 4 weekly, 35-45 minute sessions
Enhanced Usual Care and AssessmentsBehavioural
Participants will complete a symptoms questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care and Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start21 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliet Kroll, BA,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105033
- Sponsor's protocol ID
- 2025-0481
- Other IDs
- NCI-2025-05620
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Trial of Focused ACT (FACT) for Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT07105033
- Acronym / sponsor ID
- 2025-0481
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Examine Initial Acceptability and Efficacy Signal of FACT | Experimental | Behavioral: FACT SessionPotential participants will be identified weekly via MDACC's computerized appointment system for the Supportive Care Outpatient Clinic. |
| Controlled Trial (RCT) to Examine Feasibility, Acceptability and Initially Efficacy of FACT | Experimental | Behavioral: Enhanced Usual Care and AssessmentsPotential participants will be identified weekly via MDACC's computerized appointment system for the Supportive Care Outpatient Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACT SessionParticipants will participate in 4 weekly, 35-45 minute sessions | Behavioural | Examine Initial Acceptability and Efficacy Signal of FACT |
| Enhanced Usual Care and AssessmentsParticipants will complete a symptoms questionnaire | Behavioural | Controlled Trial (RCT) to Examine Feasibility, Acceptability and Initially Efficacy of FACT |
Primary outcome
1. Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juliet Kroll, BA,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FACT Session in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliet Kroll, BA,PHD ((346) 723-5858, jlkroll@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.