Acceptance and Commitment Therapy for Liver and Bile Duct Cancer

Overseen By Sofia Hammel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Psychotic symptoms, Neurological condition, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Acceptance and Commitment Therapy (ACT), a type of talk therapy, can reduce stress and improve the quality of life for people with liver or bile duct cancer. The therapy helps patients manage difficult thoughts and emotions while staying connected to what matters most to them. Eligible participants must have liver or bile duct cancer, experience distress related to their cancer, have internet access, and live in Iowa, Minnesota, or Wisconsin. As an unphased trial, this study offers a unique opportunity to explore new ways to enhance well-being and manage cancer-related stress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a behavioral therapy, so it's best to discuss your medications with the trial team.

What prior data suggests that this therapy is safe for patients with hepatobiliary cancer?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally easy for people to handle. It has been studied for its effects on various mental health issues, such as depression and coping with pain, particularly in cancer patients. Previous studies with different cancer groups, including those with breast cancer, found that ACT can help individuals become more adaptable and feel less distressed without causing major side effects. ACT involves talking sessions that help people manage their emotions and thoughts more effectively. Since this therapy does not use drugs or physical procedures, it is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for liver and bile duct cancer because it offers a novel approach to managing the psychological burden associated with these conditions. Unlike standard treatments that focus primarily on the physical aspects of cancer, ACT aims to improve mental and emotional well-being by helping patients accept their experiences and commit to actions that align with their values. Delivered through telehealth group sessions, this method is accessible and can be integrated into patients' lives without the need for in-person visits, making it convenient and potentially more appealing for individuals dealing with the challenges of cancer treatment.

What evidence suggests that Acceptance and Commitment Therapy might be an effective treatment for cancer distress?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial will receive, can reduce stress and improve mental health. Studies have found that ACT helps people manage depression and anxiety and become more accepting of pain and difficult emotions. For those with advanced cancer, ACT improves their ability to handle challenging situations. A review of several studies found that ACT significantly reduced stress and helped patients manage stress better after treatment. These findings suggest that ACT could effectively reduce stress related to liver and bile duct cancers. ^{2 3 6 7 8}

Who Is on the Research Team?

Carrie A Bronars, PhD, LP

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for patients with hepatobiliary cancers, which include liver and bile duct tumors. Participants should be experiencing distress related to their cancer diagnosis. The study aims to enroll individuals who are looking for ways to cope with the emotional challenges of their condition.

Inclusion Criteria

I have been diagnosed with hereditary breast cancer.

Able to provide written informed consent

Verbally endorse cancer distress

Exclusion Criteria

I started psychological therapy less than 2 months ago.

Inability to actively participate in and learn from group therapy (e.g., active/uncontrolled psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgement in Behavioral Medicine Program (BMP) consultation. Individual therapy or alternative group therapy will be offered to patients ineligible per this criterion

My breast cancer is in remission.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend ACT-HBC telehealth group sessions over 2 hours weekly

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy

Trial Overview The trial is testing Acceptance and Commitment Therapy (ACT-HBC), delivered through telemedicine. It involves completing questionnaires and participating in therapy sessions designed to help manage cancer-related distress by promoting psychological flexibility and adherence to personal values.

How Is the Trial Designed?

Group I: Supportive care (ACT-HBC) Experimental Treatment 3 Interventions

Patients attend ACT-HBC telehealth group sessions over 2 hours QW for 8 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. withpower.com withpower.com/trial/phase-malignant-hepatobiliary-neoplasms-4-2025-94b77

Acceptance and Commitment Therapy for Liver and Bile ... This clinical trial studies whether Acceptance and Commitment Therapy for patients with hepatobiliary cancers (ACT-HBC) can be used to help improve cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8317551/

Efficacy of acceptance and commitment therapy (ACT) on ... Analysis of results indicated that this treatment could reduce depression and increase pain acceptance and psychological flexibility in these patients. The ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03112668

Acceptance and Commitment Therapy in Improving Well ... This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their ...

4. liebertpub.com liebertpub.com/doi/full/10.1089/pancan.2017.0021

Acceptance and Commitment Therapy with Pancreatic ... Conclusion: ACT was well received by this patient with metastatic pancreatic cancer, improving ability to cope with anxiety, depression, and ...

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

a systematic review and meta-analysis of randomized ... The results revealed that ACT significantly reduced psychological distress levels and improved psychological flexibility in postintervention ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07124546

Acceptance and Commitment Therapy (ACT-HBC) for the ... This clinical trial studies whether Acceptance and Commitment Therapy for patients with hepatobiliary cancers (ACT-HBC) can be used to help ...

7. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct04907643

Virtual Reality for GI Cancer Pain to Improve Patient Reported ... To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04907643

Virtual Reality for GI Cancer Pain to Improve Patient ... This study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients ...