Hepatocellular CarcinomaHARMONYNCT06541990
Psychoeducational Intervention for Patients With Hepatocellular Carcinoma
A study testing HARMONY in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- HARMONY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 30 Jun 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
- Age ≥18 years
- New diagnosis of HCC within the last six months
- Ability to complete study procedures English
Who cannot join
- Incidentally diagnosed with HCC after liver transplantation
- Significant uncontrolled hepatic encephalopathy, cognitive impairment, or psychiatric disorder which will interfere with study participation
- Patients near the end of life for whom hospice is recommended
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kelsey Lau-Min, MD, MSCE, 857-367-1486, klau-min@mgh.harvard.edu
Kelsey Lau-Min, MD, MSCE
About this study
Official title: HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).
Read the detailed description
There are two parts of this study. Study Part 1 is an open pilot study to refine HARMONY prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine HARMONY before proceeding to Study Part 2.
Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care. Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care (a supportive care resource guide). This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HARMONY, Enhanced usual care
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARMONYBehavioural
A psychoeducational intervention for patients with HCC
Enhanced usual careOther
A supportive care resource guide
| Study group | Role | What they receive |
|---|---|---|
| HARMONY | Experimental | HARMONY is a psychoeducational intervention that consists of three one-on-one coaching sessions and a structured session workbook. Receives: Behavioral: HARMONY |
| Enhanced usual care | Active comparator | The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC. Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: study enrollment rate
≥40% enrollment among consecutive eligible patients
Measured: 10 weeks
Secondary outcomes (2)
Feasibility: intervention completion rate
≥50% completion of 2/3 intervention sessions in the HARMONY arm
Measured: 10 weeks
Acceptability
≥70% of patients in the HARMONY arm reporting Client Satisfaction Questionnaire-8 (CSQ-8) scores at or above the midpoint score of 20 on a scale from 8-32
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start28 Oct 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey S. Lau-Min, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541990
- Sponsor's protocol ID
- 24-371
- Acronym
- HARMONY
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06541990
- Acronym / sponsor ID
- HARMONY / 24-371
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Aug 2024 (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 study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).
Detailed description
There are two parts of this study. Study Part 1 is an open pilot study to refine HARMONY prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine HARMONY before proceeding to Study Part 2.
Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care. Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care (a supportive care resource guide). This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HARMONY | Experimental | Behavioral: HARMONYHARMONY is a psychoeducational intervention that consists of three one-on-one coaching sessions and a structured session workbook. |
| Enhanced usual care | Active comparator | Other: Enhanced usual careThe enhanced usual care condition consists of a curated list of supportive care services for patients with HCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- New diagnosis of HCC within the last six months
- Ability to complete study procedures English
Key exclusion criteria (3 listed)
- Incidentally diagnosed with HCC after liver transplantation
- Significant uncontrolled hepatic encephalopathy, cognitive impairment, or psychiatric disorder which will interfere with study participation
- Patients near the end of life for whom hospice is recommended
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 |
|---|---|---|
| HARMONYA psychoeducational intervention for patients with HCC | Behavioural | HARMONY |
| Enhanced usual careA supportive care resource guide | Other | Enhanced usual care |
Primary outcome
Feasibility: study enrollment rate
Time frame: 10 weeks
≥40% enrollment among consecutive eligible patients
2 secondary outcomes
Feasibility: intervention completion rate
Time frame: 10 weeks
Acceptability
Time frame: 10 weeks
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 9 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARMONY in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital 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 3 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 9 Oct 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 Kelsey Lau-Min (617-724-4000, klau-min@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: study enrollment rate (time frame: 10 weeks). 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 9 Oct 2026.