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NCT Number: NCT07124546

Acceptance and Commitment Therapy (ACT-HBC) for the Improvement of Cancer Distress in Patients With Hepatobiliary Cancers

This clinical trial studies whether Acceptance and Commitment Therapy for patients with hepatobiliary cancers (ACT-HBC) can be used to help improve cancer distress. Patients with hepatobiliary cancer (HBC) often experience high levels of distress and reductions in quality of life. ACT-HBC is a behavioral intervention tailored to patients with HBC. It helps patients cope with difficult thoughts and emotions while staying connected to what matters most in life, which may be an effective way to improve cancer distress.

Recruiting

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Key information

Conditions

Malignant Hepatobiliary Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HBC diagnosis
  • Age >= 18 years
  • Able to provide written informed consent
  • Verbally endorse cancer distress
  • Access to the internet
  • Read and write in English
  • Reside in the states of Iowa, Minnesota, or Wisconsin

Exclusion criteria

  • Other psychological therapy that started =< 2 months prior to prospective enrollment
  • 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
  • HBC remission

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

Attend ACT-HBC telehealth group sessions

Other names: ACT

Questionnaire Administration

Other

Ancillary studies

Telemedicine

Other

Attend ACT-HBC telehealth group sessions

Other names: Telehealth

Primary outcomes

  1. Patient satisfaction

    Time frame: At 8 weeks

    The Institute for Healthcare Improvement 10-point Likert scale (0-10) asks: "Would you recommend this program to your friends and family?" A score ≥ 7 indicates high individual satisfaction. Program satisfaction is achieved if 50% of individuals meet this cut-off.

  2. Patient session attendance (Feasibility)

    Time frame: At 8 weeks

    Feasibility will be determined by the number of patients attending ≥ 4 sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Deanna Hofschulte

CONTACT

[email protected]

507-255-2972

Sofia Hammel

CONTACT

[email protected]

507-255-0760

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Development of Acceptance and Commitment Therapy for Cancer Distress Among Rural and Urban Patients With Hepatobiliary Cancers (ACT-HBC)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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