FACT for Cancer

Overseen By Juliet Kroll, BA,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: ECOG status, Psychotherapy, DNR, Suicidal ideation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Focused Acceptance and Commitment Therapy (FACT) can reduce anxiety about death in cancer patients. FACT is a program designed to help individuals manage stress and cope better with their circumstances. The trial will evaluate FACT's effectiveness for patients with advanced cancer who have already tried other treatments. Eligible participants should have advanced cancer, experience moderate anxiety about death, and be open to discussing important life areas with a counselor. Participants will need access to technology for video conferencing. As an unphased trial, this study offers a unique opportunity for patients to explore new methods to manage anxiety and enhance their quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Focused Acceptance and Commitment Therapy (FACT) is safe for patients with cancer?

Research has shown that Focused Acceptance and Commitment Therapy (FACT) is generally easy for people to handle. Similar therapies, such as Acceptance Commitment Therapy (ACT), have improved mental health. For instance, online ACT helped 57% of adults with cancer feel better. Another review found that ACT reduced anxiety and depression. This suggests that FACT could be safe and helpful, as it shares these features with ACT. Studies have reported no harmful effects, indicating that FACT appears safe for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Focused Acceptance and Commitment Therapy (FACT) for cancer because it offers a fresh approach to emotional and psychological support for patients. Unlike standard treatments that might focus primarily on medication or traditional therapy, FACT helps patients engage with their thoughts and feelings in a way that promotes mental flexibility and resilience. This method is designed to improve quality of life by helping individuals commit to actions that align with their values, even in the face of difficult emotions. By potentially enhancing patients' ability to cope with cancer, FACT could complement existing medical treatments and provide a more holistic approach to care.

What evidence suggests that Focused Acceptance and Commitment Therapy (FACT) might be an effective treatment for anxiety in cancer patients?

Research has shown that Acceptance and Commitment Therapy (ACT), including Focused Acceptance and Commitment Therapy (FACT), can help reduce anxiety and fear in cancer survivors. Studies have found that ACT effectively lowers the fear of cancer recurrence and reduces anxiety, though it may not significantly impact fatigue. A review of various studies found that ACT generally reduces psychological distress, such as anxiety, in people with cancer. This trial will examine the feasibility, acceptability, and initial efficacy of FACT, suggesting it could help with anxiety about death in patients with advanced cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

Juliet Kroll, BA,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with advanced cancer who are experiencing anxiety about death. Participants should be willing to undergo psychological therapy sessions and assessments as part of the study.

Inclusion Criteria

I am an adult with advanced cancer.

Able to provide written informed consent

My cancer has worsened after at least one treatment.

Exclusion Criteria

I am currently in regular psychotherapy.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Focused Acceptance and Commitment Therapy (FACT) to reduce death-related anxiety

6 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in self-report measures of death anxiety and cognitive fusion

6 weeks

Long-term follow-up

Participants are monitored for safety and adverse events through study completion

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Focused Acceptance and Commitment Therapy (FACT)

Trial Overview The trial is testing Focused Acceptance and Commitment Therapy (FACT), a program aimed at reducing anxiety related to death in cancer patients, compared to enhanced usual care without this specific intervention.

How Is the Trial Designed?

Group I: Examine Initial Acceptability and Efficacy Signal of FACT Experimental Treatment 1 Intervention

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

Group II: Controlled Trial (RCT) to Examine Feasibility, Acceptability and Initially Efficacy of FACT Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560379/

The effect of acceptance commitment therapy on the mental ... To explore the impact of acceptance commitment therapy(ACT) to treatment on the mental health of elderly breast cancer patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1462388925000869

Acceptance and commitment therapy effectiveness for fear ... ACT can effectively reduce FCR, experiential avoidance, and anxiety in cancer survivors, though it did not significantly affect fatigue levels.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08626-4

Efficacy and cost-effectiveness of an ACT and compassion ... These trials examine the efficacy and cost-effectiveness of an integrative ACT and compassion-based intervention tailored for women with breast cancer.

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1253266/full

a systematic review and meta-analysis of randomized ... These studies summarized the efficacy of ACT on psychological distress or other symptoms (fatigue and sleep disturbance) in people with cancer.

5. publications.aap.org publications.aap.org/pediatrics/article/156/4/e2025071134/204188/Acceptance-and-Commitment-Therapy-for-Parents-of

Acceptance and Commitment Therapy for Parents of ... Acceptance and commitment therapy has demonstrated benefits for these outcomes, but its effectiveness in this population remains unexplored.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07105033

Development and Pilot Trial of Focused ACT (FACT) for ... To learn about the effects of an intervention program called Focused Acceptance and Commitment Therapy (FACT) on the level of anxiety patients ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2212144724001297

Web-based Acceptance and Commitment Therapy (ACT) ... A low intensity online ACT intervention was acceptable to adults with cancer. The negative impact of cancer on QoL was reduced reliably for 57% of participants.

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1169-8

Acceptance and commitment therapy for adults with advanced ... This feasibility randomised controlled trial of Acceptance Commitment Therapy aims to establish parameters for a larger trial.