Recruiting

ACT-HBC

Sponsor:

Mayo Clinic

Code:

NCT07124546

Conditions

Malignant Hepatobiliary Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acceptance and Commitment Therapy

Questionnaire Administration

Telemedicine

Study Details

Brief summary:

This clinical trial studies whether Acceptance and Commitment Therapy can be used to help improve cancer distress for patients with hepatobiliary or breast cancers for which no treatment is currently available (incurable). Patients with hepatobiliary cancer (HBC) and breast cancer often experience high levels of distress and reductions in quality of life. Acceptance and Commitment Therapy for incurable cancers (ACT-C) is a behavioral intervention tailored to patients with incurable HBC and breast cancer. 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.

Conditions

Malignant Hepatobiliary Neoplasm

Study ID

NCT07124546

Start date

May 28, 2025

Status verified date

Jul, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Incurable HBC and breast cancer 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 Minnesota

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
  • Cancer remission

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (ACT)

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

Interventions

Acceptance and Commitment Therapy

Attend ACT-C telehealth group sessions

Questionnaire Administration

Ancillary studies

Telemedicine

Attend ACT-C telehealth group sessions

Primary outcome measure

  • Patient satisfaction [ Time Frame: At 8 weeks ]
  • Patient session attendance (Feasibility) [ Time Frame: At 8 weeks ]

Central Contacts and Locations

Central contacts

Sofia Hammel

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

Deanna Hofschulte

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sofia Hammel

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

Deanna Hofschulte

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

Principal Investigator:

Carrie A. Bronars, PhD, LP

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-04.