Malignant Hepatobiliary NeoplasmNCT07124546
Acceptance and Commitment Therapy for the Improvement of Cancer Distress in Patients With Incurable Cancers, ACT-C Trial
A study testing Acceptance and Commitment Therapy, Questionnaire Administration and Telemedicine in people with Malignant Hepatobiliary Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hepatobiliary Neoplasm
- What is being tested?
- Acceptance and Commitment Therapy, Questionnaire Administration and Telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Sofia Hammel, 507-255-0760, Hammel.Sofia@mayo.edu
Deanna Hofschulte, 507-255-2972, Hofschulte.Deanna@mayo.edu
About this study
Official title: Development of Acceptance and Commitment Therapy for Cancer Distress Among Rural and Urban Patients With Incurable Cancers (ACT-C)
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
- Being tested
- Acceptance and Commitment Therapy, Questionnaire Administration, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
Attend ACT-C telehealth group sessions
Questionnaire AdministrationOther
Ancillary studies
TelemedicineOther
Also called Telehealth
Attend ACT-C telehealth group sessions
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (ACT) | Experimental | Patients attend ACT telehealth group sessions over 2 hours QW for 8 weeks. Receives: Behavioral: Acceptance and Commitment Therapy; Other: Questionnaire Administration; Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 8 weeks
Patient session attendance (Feasibility)
Feasibility will be determined by the number of patients attending ≥ 4 sessions.
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start28 May 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Hepatobiliary NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie Bronars, PhD, LP, Mayo Clinic
- Investigators
- Carrie A Bronars, PhD, LP, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124546
- Sponsor's protocol ID
- 24-010916
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Acceptance and Commitment Therapy for Cancer Distress Among Rural and Urban Patients With Incurable Cancers (ACT-C)
- ClinicalTrials.gov ID
- NCT07124546
- Acronym / sponsor ID
- 24-010916
- Conditions
- Malignant Hepatobiliary Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy, Other: Questionnaire Administration, Other: TelemedicinePatients attend ACT telehealth group sessions over 2 hours QW for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Incurable HBC and breast cancer diagnosis
- Age >= 18 years
- Able to provide written informed consent
- Verbally endorse cancer distress
- Access to the internet
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTAttend ACT-C telehealth group sessions | Behavioural | Supportive care (ACT) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (ACT) |
| TelemedicineAlso: TelehealthAttend ACT-C telehealth group sessions | Other | Supportive care (ACT) |
Primary outcome
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.
Patient session attendance (Feasibility)
Time frame: At 8 weeks
Feasibility will be determined by the number of patients attending ≥ 4 sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carrie A Bronars, PhD, LP principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy, Questionnaire Administration and Telemedicine in people with Malignant Hepatobiliary Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Hammel (507-255-0760, Hammel.Sofia@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: At 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.