An interventional study of HARMONY and Enhanced usual care in Hepatocellular Carcinoma, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 953 are open to participants now.
This study's planned enrollment of 50 is close to the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HARMONY is a psychoeducational intervention that consists of three one-on-one coaching sessions and a structured session workbook.
Behavioral: HARMONY
The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC.
Other: Enhanced usual care
A psychoeducational intervention for patients with HCC
A supportive care resource guide
Feasibility: study enrollment rate
≥40% enrollment among consecutive eligible patients
Time frame: 10 weeks
Feasibility: intervention completion rate
≥50% completion of 2/3 intervention sessions in the HARMONY arm
Time frame: 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
Time frame: 10 weeks
Plan to share: No
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Massachusetts General Hospital