Health TrialsbyHealthPanel

Psychoeducational Intervention for Patients With Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

New diagnosis of HCC within the last six months

Ability to complete study procedures English

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • HARMONY

    Behavioral

    A psychoeducational intervention for patients with HCC

  • Enhanced usual care

    Other intervention

    A supportive care resource guide

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: HARMONYExperimental treatment 1 intervention
Group B: Enhanced usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: study enrollment rate

≥40% enrollment among consecutive eligible patients

Time frame
10 weeks

Secondary outcomes

1

Feasibility: intervention completion rate

≥50% completion of 2/3 intervention sessions in the HARMONY arm

Time frame
10 weeks
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now