Hope Intervention for Advanced Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laurie McLouth
Disqualifiers: Unstable brain metastases, Dementia, Psychotic disorder, others
No Placebo Group
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.
12345Eligibility 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 am 18 years old or older.
I started my infusion treatment for cancer between 3 to 12 weeks ago.
+2 more
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
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: PathwaysExperimental Treatment1 Intervention
Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.
Group II: Enhanced Usual CareActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who Is Running the Clinical Trial?
Laurie McLouthLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Cytotoxic chemotherapy in advanced non-small cell lung cancer: a review of standard treatment paradigms. [2015]A 1995 meta-analysis of nine trials involving 1190 patients by the Non-Small Cell Lung Cancer Collaborative Group reported that in advanced metastatic disease, platinum-based chemotherapy provides a survival benefit compared with best supportive care. Since then, several randomized trials using either platinum-based combination regimens or selected new single agents have confirmed this observation of a modest survival advantage, as well as improved quality of life. New agents such as paclitaxel, docetaxel, vinorelbine, gemcitabine, and irinotecan have shown significant single-agent activity in advanced non-small cell lung cancer. Two recent meta-analyses have suggested that regimens including these newer agents offer modest improvement in outcomes compared with older regimens. Several randomized trials have evaluated these modern platinum-based doublets and suggested that no one combination is superior when using survival as the primary measure of outcome. Future research may improve outcomes through identifying prognostic markers of treatment response to both standard cytotoxic and newer "targeted" therapies.
Combination therapy versus single agent chemotherapy in non-small cell lung cancer. [2019]There is proven evidence of improved symptom control with platinum-based chemotherapy in the palliation of non-small cell lung cancer, and small but definite improvements in progression-free and overall survival when compared with best supportive care. The newer chemotherapy agents vinorelbine, gemcitabine, docetaxel and paclitaxel all have single agent activity, and in combination with cisplatin these provide superior quality of life and/or survival compared with the single agents, albeit with some increase in haematological toxicity. Doublet chemotherapy consisting of a new agent combined with platinum, cisplatin by preference where tolerated, has become the standard of care for advanced disease. The use of a functional assessment of fitness, rather than chronological age alone, is appropriate in the treatment of elderly patients. Although in this group there is evidence that doublets are superior to single agents, treatment should be undertaken with caution. In the second line setting where patients are unlikely to tolerate combination therapy, single agents have proven superiority over best supportive care. Patients with poor performance status (PS2) without comorbidity may tolerate combination therapy, but currently available evidence is insufficient to allow a definitive recommendation for combination or single-agent chemotherapy.
Chemotherapy for advanced non-small-cell lung cancer. [2006]The management of patients with advanced non-small-cell lung cancer has changed considerably in the last decade. Chemotherapy prolongs survival and improves quality of life in patients with a good performance status and appears to improve disease-related symptoms in patients with a lower performance status. Platinum-based doublets remain the standard regimen, but nonplatinum combinations are reasonable alternatives. Newer agents with novel mechanisms of action have opened new areas of clinical research and are likely to further improve the outcome of patients with advanced non-small-cell lung cancer.
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]After years of nihilism towards the use of chemotherapy for non small cell lung cancer in the UK it would appear that we have now reached the point where the use of chemotherapy to relieve symptoms, maintain quality of life, and prolong life, are now accepted for informed patients with good performance status willing to accept short-term toxicities. The use of the new agents vinorelbine, gemcitabine and paclitaxel in combination with cisplatin or carboplatin are all active regimens which offer small but real advantages over standard UK triple therapies (MVP, MIC) in terms of resource use, toxicity profiles and response rates. Overall survival could be increased by as much as 10% at one year on indirect comparisons. The use of docetaxel as second line therapy now offers lung cancer patients a second bite of the cherry, and should overall also prolong survival. It is only in embracing these small gains that we can currently make progress in the treatment of NSCLC.
Role of chemotherapy in patients with poor performance status and advanced non-small cell lung cancer. [2019]The treatment of advanced non-small cell lung cancer remains an important area of research, with many questions about the use of chemotherapy still unanswered. It is now recognized that chemotherapy improves survival and alleviates disease-related symptoms in the population with advanced non-small cell lung cancer. However, it is unknown whether these benefits apply to patients with poor performance status (PS). These patients (Eastern Cooperative Oncology Group PS2) have inferior outcomes compared with more fit patients, and historically, they have been excluded from clinical trials. In other trials with broader eligibility, PS2 patients comprised fewer than 20% of the study populations. These factors have led to difficulty in ascertaining true outcomes in the PS2 patient population. However, the PS2 population accounts for a significant portion (up to 30% to 40%) of patients in oncology practice, and emerging data suggest that these patients may in fact garner benefits, such as prolonged survival and improved quality of life, from chemotherapy. Studies with single-agent vinorelbine or paclitaxel have shown improved survival with chemotherapy versus supportive care that remain significant when stratified by PS. A recent subset analysis of PS2 patients enrolled in a trial comparing carboplatin and paclitaxel with single-agent paclitaxel suggests that combination chemotherapy is a feasible option and is potentially preferable to single-agent therapy. Importantly, several analyses have shown that toxicity is not necessarily worse in this population compared with more fit patients. Because optimal agents or combinations have not been defined, novel strategies and therapeutics are urgently needed in this population.