Psychoeducational Therapy for Liver Cancer

(HARMONY Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Hepatic encephalopathy, Cognitive impairment, Hospice, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment HARMONY, HARMONY for liver cancer?

Research shows that psychoeducational therapy, which is part of the HARMONY treatment, can help cancer patients by reducing symptoms like depression and anxiety, and improving their quality of life. This type of therapy has been effective in other types of cancer, suggesting it may also benefit liver cancer patients. ^{1 2 3 4 5}

Is psychoeducational therapy safe for liver cancer patients?

The available research on psychoeducational and psychosocial interventions for cancer patients, including those undergoing chemotherapy, suggests these therapies are generally safe and well-accepted. They have been shown to help with emotional distress, anxiety, and depression, improving overall quality of life. ^{1 2 6 7 8}

How is the HARMONY treatment for liver cancer different from other treatments?

HARMONY is unique because it focuses on psychoeducation, which helps patients understand and manage the emotional and mental aspects of cancer, unlike traditional treatments that primarily target the physical symptoms. This approach aims to improve patients' quality of life and emotional well-being by teaching self-evaluation and self-regulation of the mind-body process. ^{9 10 11 12 13}

Research Team

Eligibility Criteria

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 am 18 years old or older.

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

I have been diagnosed with cirrhosis.

Trial Timeline

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

Treatment Details

Interventions

• HARMONY (Behavioral Intervention)

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.

Participant Groups

Group I: HARMONY Experimental Treatment 1 Intervention

HARMONY is a psychoeducational intervention that consists of five 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+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Psycho-oncologic interventions--critical review]. [2006]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of pretreatment video-based psychoeducation for patients with breast cancer. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Psychological Service for Patients With Cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Acceptability of psychotherapy, pharmacotherapy, and self-directed therapies in Australians living with chronic hepatitis C. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the effectiveness of web-based psychosocial interventions among patients with colorectal cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Guided Biopsychosocial Online Intervention for Cancer Patients Undergoing Chemotherapy. [2022]

9. Thailand pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Moderators of an uncertainty management intervention: for men with localized prostate cancer. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Psychoeducation for breast cancer: A systematic review and meta-analysis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Patient-centered care in cancer treatment programs: the future of integrative oncology through psychoeducation. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[Psychotherapeutic and psychosocial interventions in cancer]. [2018]