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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HARMONY | Experimental | HARMONY is a psychoeducational intervention that consists of three one-on-one coaching sessions and a structured session workbook. |
|
| Enhanced usual care | Active Comparator | The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HARMONY | Behavioral | A psychoeducational intervention for patients with HCC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: study enrollment rate | ≥40% enrollment among consecutive eligible patients | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: intervention completion rate | ≥50% completion of 2/3 intervention sessions in the HARMONY arm | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Lau-Min | Contact | 617-724-4000 | klau-min@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C087247 | Harmony Hard |
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| Enhanced usual care |
| Other |
A supportive care resource guide |
|
| 10 weeks |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |