Multimedia Self-Management for Lung Cancer Caregivers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Stage IV cancer, others

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

Compensation: Varies

Number of Visits: 6

380 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.

Do I need to stop 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 doctor.

What data supports the effectiveness of the treatment Multimedia Self-Management Intervention for lung cancer caregivers?

Research on similar multimedia self-management programs for other cancers, like prostate cancer, shows they can increase knowledge and reduce distress. This suggests that the Multimedia Self-Management Intervention for lung cancer caregivers might also help improve understanding and emotional well-being. ^{1 2 3 4 5}

Is the Multimedia Self-Management Intervention safe for humans?

The Multimedia Self-Management Intervention has been evaluated for its feasibility and acceptability in preparing cancer patients and caregivers for lung surgery, and it is considered informative and easy to understand by both patients and health professionals. There is no specific mention of safety concerns in the available research, suggesting it is generally safe for use. ^{1 2 3 6 7}

How is the Multimedia Self-Management Intervention treatment for lung cancer caregivers different from other treatments?

The Multimedia Self-Management Intervention is unique because it uses multimedia tools to prepare both lung cancer patients and their caregivers for surgery and recovery, focusing on education and self-management skills. This approach is novel as it combines interactive technology with caregiver training, which is not commonly found in standard treatments for lung cancer. ^{1 2 3 8 9}

Research Team

Virginia Sun, RN, PhD

Principal Investigator

City of Hope Medical Center

Jae Kim, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adult family caregivers and patients with Stage I-III non-small cell lung cancer who are preparing for surgery. Caregivers must be the primary care provider, identified by the patient, both before and after surgery. Participants need to be at least 21 years old and able to read or understand English.

Inclusion Criteria

I am 21 years old or older.

A family caregiver enrolled in the study

Able to read or understand English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Surgery Preparation

Participants and family caregivers receive the multimedia self-management intervention or attention control intervention 3-7 days before surgery

1 week

1 visit (in-person)

Post-Surgery Intervention

Participants and family caregivers receive support and intervention within 24 hours of planned discharge and via telephone at 2 and 7 days post-discharge

2 weeks

3 visits (telephone)

Follow-up

Participants are monitored for outcomes such as psychological distress, quality of life, and healthcare resource use at 1 month and 3 months post-discharge

3 months

2 visits (telephone)

Treatment Details

Interventions

• Multimedia Self-Management Intervention

Trial Overview The study tests a multimedia self-management intervention called 'Preparing for your Lung Cancer Surgery.' It's nurse-led, aimed at caregivers, involves educational media about prepping for surgery, and aims to improve patient recovery post-surgery while reducing caregiver burden.

Participant Groups

Group I: Group I (MSM intervention) Experimental Treatment 2 Interventions

Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support via telephone(separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.

Group II: Group II (Attention Control) Active Control 2 Interventions

Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a CRA approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone at 2 and 7 days, and 2 months post-discharge.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Mobile health-based self-management interventions significantly improve self-management behaviors, functional exercise compliance, self-efficacy, and health-related quality of life in breast cancer patients, based on a meta-analysis of 24 studies.

These interventions also reduce the incidence of lymphedema and alleviate anxiety levels, although they do not show significant differences in symptom relief, role functioning, or social support compared to conventional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile health-based self-management interventions in breast cancer patients: a meta-analysis. Luo, X., Chen, Y., Chen, J., et al.[2022]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

Patients with lung cancer reported an average of 14 symptoms causing moderate distress, and their ability to manage these symptoms was influenced by their level of interactive health literacy, which was found to be in the moderate range.

Higher interactive health literacy allowed patients to better engage with healthcare providers about symptom management strategies, suggesting that improving these skills could enhance patient confidence and effectiveness in self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Health Literacy and Symptom Self-management in Patients With Lung Cancer: A Critical Realist Analysis. Campbell, JK., Erickson, JM.[2023]

References

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

Improving family caregiver and patient outcomes in lung cancer surgery: Study protocol for a randomized trial of the multimedia self-management (MSM) intervention. [2023]

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

Preparing Cancer Patients and Family Caregivers for Lung Surgery: Development of a Multimedia Self-Management Intervention. [2019]

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

A Multimedia Self-management Intervention to Prepare Cancer Patients and Family Caregivers for Lung Surgery and Postoperative Recovery. [2018]

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

The utility of a multimedia education program for prostate cancer patients: a formative evaluation. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile health-based self-management interventions in breast cancer patients: a meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Development and evaluation of an audiovisual information resource to promote self-management of chemotherapy side-effects. [2018]

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

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. [2023]

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

Interactive Health Literacy and Symptom Self-management in Patients With Lung Cancer: A Critical Realist Analysis. [2023]

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

An e-learning caregiving program for prostate cancer patients and family members. [2019]