Psychoeducational Therapy for Liver Cancer

(HARMONY Trial)

Overseen By Kelsey Lau-Min

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Hepatic encephalopathy, Cognitive impairment, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called HARMONY, designed to support individuals recently diagnosed with liver cancer, specifically hepatocellular carcinoma. The goal is to evaluate how well this program aids patients through three coaching sessions and a guiding workbook. Participants will receive either this new program or a list of existing supportive care services. This trial may suit individuals diagnosed with liver cancer in the past six months who can participate in English language sessions. As an unphased trial, it offers a unique opportunity to contribute to innovative supportive care research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the HARMONY intervention is safe for patients with liver cancer?

Research has shown that programs like HARMONY, which focus on education and emotional support, are generally safe and well-received. These programs do not involve drugs or medical procedures. Instead, they provide coaching sessions and workbooks to assist participants. As a result, side effects are not usually a concern. Participants often report reduced stress and improved quality of life. Since HARMONY does not involve physical procedures, the risk of harm is minimal, making it a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HARMONY because it introduces a psychoeducational approach to supporting liver cancer patients, which is quite different from the typical medical treatments like surgery, chemotherapy, or targeted therapy. HARMONY offers three personalized coaching sessions combined with a structured workbook, aiming to empower patients through education and emotional support. This method could enhance patient well-being by addressing the psychological aspects of living with liver cancer, something traditional treatments often overlook.

What evidence suggests that the HARMONY psychoeducational intervention is effective for liver cancer?

Research has shown that the HARMONY program, which participants in this trial may receive, might help reduce stress and improve the quality of life for individuals newly diagnosed with liver cancer. This program includes three personal coaching sessions and a workbook with guided activities. Early results suggest that participants felt less stressed and more informed about their condition after participating. While detailed data is still being gathered, the program aims to provide emotional and mental support to patients as they manage their diagnosis. Efforts continue to enhance this program to better serve liver cancer patients. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been newly diagnosed with hepatocellular carcinoma (HCC), a type of liver cancer, within the last three months. They must also have cirrhosis (liver damage) and be able to complete study procedures in English.

Inclusion Criteria

I was diagnosed with liver cancer in the last 3 months.

I have been diagnosed with cirrhosis.

I can complete study tasks in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the HARMONY psychoeducational intervention or enhanced usual care for 12 weeks

12 weeks

5 one-on-one coaching sessions for HARMONY group

Follow-up

Participants are monitored for feasibility and acceptability outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HARMONY

Trial Overview The trial is testing HARMONY, a new psychoeducational program designed to support patients with HCC. It will be compared against enhanced usual care to see if it offers additional benefits.

How Is the Trial Designed?

Group I: HARMONY Experimental Treatment 1 Intervention

HARMONY is a psychoeducational intervention that consists of three one-on-one coaching sessions and a structured session workbook.

Group II: Enhanced usual care Active Control 1 Intervention

The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Pretreatment video-based psychoeducation significantly reduced levels of depression, anxiety, and uncertainty in breast cancer patients, with moderate effect sizes observed for depression (-0.57) and small for anxiety (-0.25) at 3 months post-intervention.

In contrast, the control group experienced an increase in depression scores at 3 months, highlighting the potential benefits of early psychoeducational interventions for managing mental health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of pretreatment video-based psychoeducation for patients with breast cancer. Sato, T., Seto, M., Sangai, T., et al.[2023]

Web-based psychosocial interventions, particularly cognitive-behavioral therapy, significantly reduce anxiety and depression in colorectal cancer survivors, as shown in a systematic review of 19 studies with 1386 participants.

However, these interventions did not show a positive effect on self-efficacy and had minimal benefits on quality of life, indicating the need for further research to improve these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the effectiveness of web-based psychosocial interventions among patients with colorectal cancer. Wan, SW., Chng, YJD., Lim, SH., et al.[2022]

Supportive psycho-oncological interventions, such as education, individual psychotherapy, and group therapy, have been shown to effectively reduce symptoms like pain, anxiety, and depression in cancer patients, thereby improving their quality of life.

The review highlights the need for further research into how psychological factors can influence cancer progression and survival rates, suggesting that understanding these connections could enhance treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psycho-oncologic interventions--critical review]. Larbig, W.[2006]

Psychological interventions, especially cognitive behavioral therapy and supportive-expressive group therapy, significantly improve the quality of life for cancer patients, as supported by randomized trials.

While the impact of psychological interventions on survival rates is unclear, addressing feelings of helplessness and hopelessness through therapy can enhance both quality of life and potentially survival outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological intervention. The gap between research and practice. Greer, S.[2019]

A psychological service for cancer patients at a community hospital, involving a licensed psychologist and clinical psychology doctoral students, was developed and evaluated over 3 years, serving 238 patients aged 18 to 95.

Patients who engaged in the service showed a significant reduction in depression levels, although anxiety levels did not change significantly, highlighting the potential benefits of integrating psychosocial care into cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Psychological Service for Patients With Cancer. Yusufov, M., Grebstein, L., Rossi, JS., et al.[2022]

The study found that lower education levels in African-American and White men with localized prostate cancer significantly improved their cancer knowledge when participating in a psycho-educational Uncertainty Management Intervention.

Additionally, fewer sources of cancer information and lower levels of extrinsic religiosity were linked to better patient-provider communication, indicating that these individual characteristics can influence the effectiveness of psycho-educational interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderators of an uncertainty management intervention: for men with localized prostate cancer. Mishel, MH., Germino, BB., Belyea, M., et al.[2022]

Psychosocial support is essential for cancer patients and their families, with evidence showing that various psychotherapeutic interventions, such as counseling and cognitive-behavioral therapy, are effective in addressing their needs.

Despite the recognized importance of psychosocial support, implementation in healthcare systems faces challenges, highlighting the need for routine screening of cancer patients for psychosocial distress to identify those who require support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapeutic and psychosocial interventions in cancer]. Herschbach, P.[2018]

A study of 156 Australian patients with chronic hepatitis C revealed high levels of depression, anxiety, and stress, indicating a significant need for psychological support in this population.

Individual psychotherapy was the most accepted form of psychological support (83%), while less traditional methods like group or online therapy had lower acceptability, suggesting that patient preferences could impact the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of psychotherapy, pharmacotherapy, and self-directed therapies in Australians living with chronic hepatitis C. Stewart, BJ., Turnbull, D., Mikocka-Walus, AA., et al.[2021]

The OPaCT online intervention for cancer patients undergoing chemotherapy was found to be feasible and acceptable, with 80.4% of the 46 participants completing the program and reporting high satisfaction levels.

Participants showed significant improvements in addressing their psychological needs during treatment, indicating that OPaCT could help reduce unmet psychological care needs for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Guided Biopsychosocial Online Intervention for Cancer Patients Undergoing Chemotherapy. Grapp, M., Rosenberger, F., Hemlein, E., et al.[2022]

Psychosocial support for cancer patients is crucial for enhancing their quality of life by addressing not only emotional distress but also managing cancer symptoms and treatment side effects.

Interventions can be categorized into five types: prevention, early detection, restoration, support, and palliation, each tailored to meet the varying needs of patients throughout their cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychiatrist's perspective on quality of life and quality of care in oncology: concepts, symptom management, communication issues. Razavi, D., Delvaux, N.[2019]

The mind-body connection is crucial for enhancing psychosocial care in cancer patients, as emotions significantly influence decision-making and symptom management.

Implementing psychoeducation in integrative oncology can empower patients by improving their emotional and cognitive skills, which may help bridge the gap between research and clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered care in cancer treatment programs: the future of integrative oncology through psychoeducation. Garchinski, CM., DiBiase, AM., Wong, RK., et al.[2022]

Psychoeducation significantly reduced anxiety levels and improved the quality of life (QoL) for women with breast cancer, based on a meta-analysis of 27 randomized controlled trials involving 7742 participants.

However, psychoeducation did not show a significant impact on adherence to diagnostic procedures, treatment, depression, or breast cancer knowledge, indicating its benefits may be more focused on emotional support rather than treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation for breast cancer: A systematic review and meta-analysis. Setyowibowo, H., Yudiana, W., Hunfeld, JAM., et al.[2022]

A psychoeducational program consisting of eight weekly sessions significantly improved adjustment to cancer in stage I-II breast cancer patients, with participants showing increased 'fighting spirit' and decreased feelings of 'helplessness' and 'anxious preoccupation' after the intervention.

The study involved 76 women (38 in the experimental group and 38 in the control group) and demonstrated that while psychoeducation positively influenced emotional adjustment, it did not significantly affect levels of 'avoidance/denial' compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation intervention to improve adjustment to cancer among Turkish stage I-II breast cancer patients: a randomized controlled trial. Dastan, NB., Buzlu, S.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06541990

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

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/524764

Psychoeducational Intervention for Patients With ... This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-07869

A Psychoeducational Intervention to Reduce Psychological ... Using the HARMONY intervention may help reduce psychological distress and improve QOL for patients with newly diagnosed liver cancer. Eligibility Criteria ...

4. ctv.veeva.com ctv.veeva.com/study/psychoeducational-intervention-for-patients-with-hepatocellular-carcinoma

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

5. clinconnect.io clinconnect.io/trials/NCT06541990

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

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06541990

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