Symptom Self-Management for Lung Cancer

Recruiting at 2 trial locations

Overseen By Molly Hadeed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Immune checkpoint inhibitors

Disqualifiers: Regular behavioral counseling

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Symptom Self-Management for Lung Cancer?

Research shows that both nurse-assisted and automated telephone symptom management can significantly reduce symptom severity in cancer patients, including those with lung cancer. Additionally, proactive telephone counseling has been effective in promoting smoking cessation, which is beneficial for lung cancer patients. ^{1 2 3 4 5}

Is Automated Telephone Symptom Management (ATSM) safe for use in humans?

The Automated Telephone Symptom Management (ATSM) system has been tested in cancer patients undergoing chemotherapy and was found to significantly reduce symptom severity without any reported safety issues. However, lung cancer patients with severe symptoms were more likely to withdraw from the ATSM intervention, suggesting it may be less effective in retaining these patients. ^{1 3 4 6 7}

How is the treatment Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C) unique for lung cancer?

This treatment is unique because it combines automated telephone systems with interpersonal counseling to help lung cancer patients manage their symptoms, offering a more interactive and supportive approach compared to traditional methods. It allows real-time symptom reporting and management, which can be particularly beneficial for patients experiencing severe symptoms. ^{3 4 7 8 9}

Research Team

Terry Badger, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for adults over 18 who have started treatment with immune checkpoint inhibitors (ICIs) for various cancers within the last 12 weeks. Participants must be able to communicate in English or Spanish, have access to a phone, and show mild psychological distress. Those already receiving regular behavioral counseling cannot join.

Inclusion Criteria

I am 18 years old or older.

I started immunotherapy for cancer less than 12 weeks ago.

I am mentally aware of who I am, where I am, and the current time.

Exclusion Criteria

I am currently undergoing regular counseling sessions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Automated Telephone Symptom Management (ATSM) or active control condition for 16 weeks, with weekly symptom monitoring and potential addition of Telephone Interpersonal Counseling (TIPC) for nonresponders

16 weeks

Weekly telephone assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with interviews conducted at week 17

1 week

1 visit (telephone interview)

Treatment Details

Interventions

• Active control comparator
• Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)

Trial Overview The study tests two support methods for managing symptoms during ICI cancer treatment: Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C), compared against an active control group.

Participant Groups

Group I: Adaptive Intervention Experimental Treatment 1 Intervention

The adaptive intervention sequence is assumed to affect psychological distress (depression and anxiety) severity of other symptoms and irAEs, as tested in Aim 1. Both the Automated Telephone Symptom Management (ATSM) system and the Telephone Interpersonal Counseling (TIP-C) interventions help participants to identify and understand troublesome symptoms, with suggestions to effectively self-manage these symptoms. The proposed interventions are expected to alleviate burdensome symptoms through several key mediating variables, as tested in Aim 2.

Group II: Active Control Active Control 1 Intervention

Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe. An active control comparator was purposively selected to enable a more rigorous testing of intervention effectiveness in Aims 1 and 2. Also, the study team will be better able to address the question about which channel of communication (automated versus survivor initiated) results in better outcomes.

Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C) is already approved in United States for the following indications:

Approved in United States as ATMS and TIP-C for:

• Symptom management for patients on immune checkpoint inhibitors

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A study analyzing 102 unscheduled phone calls to a cancer pain clinic found that 74% of calls were made by patients or caregivers, primarily to report symptoms or treatment concerns, with pain being the most common issue reported (59.6%).

The cancer pain nurse effectively managed 87.3% of these calls without needing a doctor, providing interventions that included treatment adjustments and patient education, highlighting the importance of telephone consultations in improving patient care and reducing unnecessary emergency department visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Unscheduled Telephone Calls Received by a Specialized Cancer Pain Nurse. Remy, C., Borniard, J., Perez, J.[2021]

A randomized controlled trial involving 496 participants (245 in the proactive counseling group and 251 in the control group) found that proactive telephone counseling did not significantly improve smoking cessation rates overall, but younger participants (<50 years) showed a higher cessation rate at 2 weeks (16% vs. 4%).

The study suggests that while proactive counseling aimed at teaching coping skills was challenging to implement, it may still hold potential for younger smokers in the social networks of lung cancer patients, indicating a need for further research to optimize such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. Bastian, LA., Fish, LJ., Peterson, BL., et al.[2022]

In a study involving 435 cancer patients undergoing chemotherapy, both nurse-assisted symptom management (NASM) and automated telephone symptom management (ATSM) significantly reduced symptom severity, showing that both methods are effective for managing symptoms during treatment.

While both interventions were effective, NASM appeared to be better at keeping lung cancer patients engaged in the program, suggesting that combining ATSM with NASM could be beneficial for patients experiencing severe symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom management for cancer patients: a trial comparing two multimodal interventions. Sikorskii, A., Given, CW., Given, B., et al.[2018]

The Automated Telephone Symptom Management (ATSM) intervention was found to be more effective than the cognitive behavioral approach for patients with metastatic breast cancer, leading to greater symptom responses in shorter time frames.

Patients receiving single-agent chemotherapy experienced better symptom responses and quicker times to response compared to those on combination chemotherapy, highlighting the importance of treatment type in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing symptoms among patients with breast cancer during chemotherapy: results of a two-arm behavioral trial. Given, CW., Sikorskii, A., Tamkus, D., et al.[2022]

An automated text messaging intervention was found to be a cost-effective method for managing symptoms in patients with cancer-related issues.

This approach offers a convenient way for patients to receive support and information, potentially improving their overall symptom management experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Mobile Messaging System for Self-Management of Chemotherapy Symptoms in Patients with Advanced Cancer. Jaenicke, C., Greenwood, D., Nelson, K., et al.[2020]

WebChoice is a new Internet-based support system designed to help cancer patients monitor their symptoms and manage their disease effectively, providing tailored self-management options and a communication platform with clinical specialists and peers.

A randomized clinical trial is currently underway to evaluate the impact of WebChoice on patient outcomes, indicating a commitment to assessing its efficacy in improving the care of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing tailored Internet support to assist cancer patients in illness management. Ruland, CM., Jeneson, A., Andersen, T., et al.[2022]

A pilot study involving 45 patients with advanced or metastatic non-small cell lung cancer (NSCLC) showed that a digital patient monitoring and management (DPMM) tool significantly improved communication between patients and healthcare professionals (HCPs), with high user satisfaction ratings (mean ratings of 4.2 to 4.4) for its usability and effectiveness.

The DPMM tool helped streamline clinical workflows, reducing the need for phone consultations and patient visits, although some challenges related to workload were noted, indicating a need for better integration into existing clinical systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Monitoring and Management of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Treated With Cancer Immunotherapy and Its Impact on Quality of Clinical Care: Interview and Survey Study Among Health Care Professionals and Patients. Schmalz, O., Jacob, C., Ammann, J., et al.[2021]

Patients with cancer expressed a need for a self-management system that allows them to connect with others, customize information, and track their symptoms over time, highlighting the importance of community and personalized support during treatment.

Clinicians and patients both emphasized the necessity of optimizing resources to better support cancer self-management, indicating that the I Can Manage Cancer (ICMC) program is designed to address these critical needs identified through interviews and focus groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and clinician perspectives of desired features for a web-based self-management program (icanmanage.ca): exposing patients "hard work" of managing acute cancer. Haase, KR., Avery, J., Bryant-Lukosius, D., et al.[2021]

A study involving 163 cancer patients assessed the effectiveness of a web-based cognitive behavioral therapy (CBT) intervention called CancerCope, which showed significant reductions in psychological distress and unmet psychological care needs for those who adhered closely to the program.

While the overall results did not show a statistically significant effect compared to a static education website, the findings suggest that this low-cost, accessible intervention could be beneficial, particularly for younger patients who are more likely to complete the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial. Chambers, SK., Ritterband, LM., Thorndike, F., et al.[2019]

References

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

Analysis of Unscheduled Telephone Calls Received by a Specialized Cancer Pain Nurse. [2021]

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

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. [2022]

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

Symptom management for cancer patients: a trial comparing two multimodal interventions. [2018]

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

Managing symptoms among patients with breast cancer during chemotherapy: results of a two-arm behavioral trial. [2022]

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

Use of Mobile Messaging System for Self-Management of Chemotherapy Symptoms in Patients with Advanced Cancer. [2020]

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

Designing tailored Internet support to assist cancer patients in illness management. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Digital Monitoring and Management of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Treated With Cancer Immunotherapy and Its Impact on Quality of Clinical Care: Interview and Survey Study Among Health Care Professionals and Patients. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Patient and clinician perspectives of desired features for a web-based self-management program (icanmanage.ca): exposing patients "hard work" of managing acute cancer. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial. [2019]