Hope Intervention for Advanced Lung Cancer

Overseen By Laurie McLouth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laurie McLouth

Disqualifiers: Unstable brain metastases, Dementia, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 6

234 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

How does the drug Pathways (Duphalac, Kristalose) differ from other treatments for advanced lung cancer?

Pathways (Duphalac, Kristalose) is unique because it is not a standard chemotherapy drug for lung cancer; it is typically used as a laxative to treat constipation. This suggests a novel approach in the trial, potentially focusing on improving quality of life or addressing specific symptoms rather than directly targeting cancer cells. ^{1 2 3 4 5}

Research Team

Laurie McLouth, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults over 18 with advanced lung cancer who are already a few weeks into infusion-based treatment. They should be experiencing some distress but not have severe cognitive or psychiatric conditions, unstable brain metastases, or be receiving similar care elsewhere.

Inclusion Criteria

I have felt significant distress or psychological discomfort recently.

I started my infusion treatment for cancer between 3 to 12 weeks ago.

My lung cancer is at an advanced stage.

Exclusion Criteria

My brain metastases are stable; I don't have worsening symptoms, uncontrolled seizures, or increasing need for steroids.

I am getting supportive care or mental health services at the cancer center.

Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline survey measures and are randomized to intervention

1 week

Intervention

Participants receive either the Pathways intervention or Enhanced Usual Care

6 weeks

Mid-intervention and post-intervention assessments

Follow-up

Participants are monitored for changes in mental health and quality of life at 6- and 12-week follow-up

12 weeks

Assessments at 6 and 12 weeks

Treatment Details

Interventions

• Enhanced Usual Care
• Pathways

Trial Overview The study tests 'Pathways', a supportive intervention aimed at improving mental health and quality of life during advanced lung cancer treatment, against enhanced usual care. Participants will answer surveys before and after the intervention to measure its impact.

Participant Groups

Group I: Pathways Experimental Treatment 1 Intervention

Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.

Group II: Enhanced Usual Care Active Control 1 Intervention

Enhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center).

Enhanced Usual Care is already approved in United States, European Union, China for the following indications:

Approved in United States as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in European Union as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in China as Lactulose for:

• Hepatic encephalopathy
• Constipation

Who Is Running the Clinical Trial?

Laurie McLouth

Lead Sponsor

Trials

4

Recruited

400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A meta-analysis of nine trials with 1190 patients showed that platinum-based chemotherapy provides a survival benefit for patients with advanced non-small cell lung cancer compared to best supportive care.

Recent studies indicate that newer agents like paclitaxel and docetaxel, when combined with platinum-based regimens, offer modest improvements in survival and quality of life, but no single combination has been found superior in terms of survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytotoxic chemotherapy in advanced non-small cell lung cancer: a review of standard treatment paradigms. Socinski, MA.[2015]

Platinum-based chemotherapy has been shown to improve symptom control and provide small but significant improvements in progression-free and overall survival for patients with non-small cell lung cancer compared to best supportive care.

Combination chemotherapy using newer agents with cisplatin is now the standard treatment for advanced disease, offering better quality of life and survival, although it may increase the risk of hematological toxicity, especially in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy versus single agent chemotherapy in non-small cell lung cancer. Cheong, K., Spicer, J., Chowdhury, S., et al.[2019]

Chemotherapy, particularly platinum-based doublets, has been shown to prolong survival and enhance quality of life in patients with advanced non-small-cell lung cancer, especially those with a good performance status.

The introduction of newer agents with different mechanisms of action is paving the way for improved treatment outcomes, indicating a shift in management strategies for this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy for advanced non-small-cell lung cancer. Raez, LE., Lilenbaum, R.[2006]

Chemotherapy is now recognized as a viable option for patients with non-small cell lung cancer (NSCLC) in the UK, focusing on symptom relief, quality of life, and life prolongation for those with good performance status willing to tolerate short-term side effects.

New chemotherapy agents like vinorelbine, gemcitabine, and paclitaxel, especially when combined with cisplatin or carboplatin, show small but significant improvements in response rates and overall survival compared to older treatments, potentially increasing one-year survival by up to 10%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The case for the introduction of new chemotherapy agents in the treatment of advanced non small cell lung cancer in the wake of the findings of The National Institute of Clinical Excellence (NICE). Waters, JS., O'Brien, ME.[2023]

Chemotherapy has been shown to improve survival and quality of life in patients with advanced non-small cell lung cancer, including those with poor performance status (PS2), who historically have been underrepresented in clinical trials.

Recent studies indicate that PS2 patients can benefit from chemotherapy, with combination treatments like carboplatin and paclitaxel potentially offering better outcomes than single-agent therapies, without significantly increased toxicity compared to fitter patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of chemotherapy in patients with poor performance status and advanced non-small cell lung cancer. Langer, C., Lilenbaum, R.[2019]

References

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

Cytotoxic chemotherapy in advanced non-small cell lung cancer: a review of standard treatment paradigms. [2015]

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

Combination therapy versus single agent chemotherapy in non-small cell lung cancer. [2019]

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

Chemotherapy for advanced non-small-cell lung cancer. [2006]

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

The case for the introduction of new chemotherapy agents in the treatment of advanced non small cell lung cancer in the wake of the findings of The National Institute of Clinical Excellence (NICE). [2023]

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

Role of chemotherapy in patients with poor performance status and advanced non-small cell lung cancer. [2019]