NCT07124546

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
May 2025May 2027

Study Start

First participant enrolled

May 28, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 8, 2025

Last Update Submit

August 8, 2025

Conditions

Malignant Hepatobiliary Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Patient satisfaction

    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.

    At 8 weeks

  • Patient session attendance (Feasibility)

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

    At 8 weeks

Study Arms (1)

Supportive care (ACT-HBC)

EXPERIMENTAL

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

Behavioral: Acceptance and Commitment TherapyOther: Questionnaire AdministrationOther: Telemedicine

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

Attend ACT-HBC telehealth group sessions

Also known as: ACT
Supportive care (ACT-HBC)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (ACT-HBC)
TelemedicineOTHER

Attend ACT-HBC telehealth group sessions

Also known as: Telehealth
Supportive care (ACT-HBC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Acceptance and Commitment TherapyTelemedicine

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Carrie A Bronars, PhD, LP

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Hammel

CONTACT

507-255-0760Hammel.Sofia@mayo.edu

Deanna Hofschulte

CONTACT

507-255-2972Hofschulte.Deanna@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 15, 2025

Study Start

May 28, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)