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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a multimedia self-management program, known as the Multimedia Self-Management Intervention, can assist family caregivers and patients with stage I-III lung cancer in preparing for lung surgery. The program includes videos, a handbook, and nurse coaching to enhance patient recovery, reduce caregiver stress, and improve overall quality of life. Participants will be divided into two groups: one using the multimedia program and the other receiving standard care materials. This trial suits those diagnosed with early to mid-stage non-small cell lung cancer who plan to undergo surgery and have a family member or friend as their main caregiver. As an unphased trial, this study allows participants to contribute to innovative research that could significantly enhance the surgical experience for future patients and caregivers.

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 prior data suggests that this multimedia self-management intervention is safe for lung cancer caregivers?

Research has shown that the Multimedia Self-Management (MSM) program aids lung cancer patients and their caregivers before and after surgery. Studies have found that this program can enhance patient recovery and reduce caregiver stress.

The MSM program is safe and user-friendly. It includes watching videos, reading a handbook, and receiving phone support from nurses. Since it involves no medications or physical treatments, participants do not experience drug-related side effects. Previous participants found the MSM program helpful and easy to follow.

Overall, the MSM program is considered safe for both lung cancer patients and their caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multimedia Self-Management (MSM) intervention for lung cancer caregivers because it combines personalized support with multimedia resources, offering a more comprehensive approach than typical educational materials alone. Unlike standard care, which might involve generic information, this intervention provides tailored guidance through videos, a handbook, and one-on-one coaching from a research nurse. This personalized touch is reinforced with follow-up support, ensuring caregivers and patients are well-prepared before surgery and during recovery, potentially leading to better outcomes for both.

What evidence suggests that this multimedia self-management intervention is effective for lung cancer caregivers?

Research has shown that a multimedia self-management (MSM) program, which participants in this trial may receive, benefits both caregivers and patients preparing for lung cancer surgery. Studies have found that this program helps individuals feel more prepared for surgery and supports their recovery afterward. It also reduces the stress and challenges family caregivers often face, improving the quality of life for both patients and caregivers. The program includes videos, handbooks, and guidance from a nurse, which greatly aids patients and caregivers in managing the surgery process. ^{1 4 6 7 8}

Who Is on the Research Team?

Virginia Sun, RN, PhD

Principal Investigator

City of Hope Medical Center

Jae Kim, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28233696/

A Multimedia Self-management Intervention to ... - PubMed

A standardized MSM intervention was feasible and acceptable in supporting readiness and preparedness for lung surgery and postoperative recovery.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5413411/

A Multimedia Self-Management Intervention to Prepare ...

Our previous research suggests that lung cancer family caregivers experience significant psychological distress, higher caregiver burden, and decreased QOL ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S155171441930117X

Improving family caregiver and patient outcomes in lung ...

The purpose of this paper is to describe the study protocol of an intervention (Multimedia Self-Management – MSM) to prepare caregiver-patient dyads for lung ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1525730417300396

A Multimedia Self-management Intervention to Prepare ...

Our previous research suggests that lung cancer family caregivers experience significant psychological distress, higher caregiver burden, and decreased QOL ...

5.

withpower.com

withpower.com/trial/phase-lung-neoplasms-10-2018-e1b6c

Multimedia Self-Management for Lung Cancer Caregivers

This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage ...

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jto.org

jto.org/article/S1556-0864(16)33249-X/pdf

PUB038 A Multimedia Self-Management Intervention to Prepare ...

A Multimedia Self-Management. Intervention to Prepare Patients and. Family Caregivers for Lung Surgery. Virginia Sun,1 Jae Kim,2 Nora Ruel,3 Dan Raz,2. Walter ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6661176/

Improving Family Caregiver and Patient Outcomes in Lung ...

To describe the study protocol of the Multimedia Self-Management Intervention (SMI) to prepare patients and family caregivers (FCGs) for lung cancer surgery.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0169500225003769

Identifying and exploring patient engagement interventions ...

This is the first study to synthesise engagement interventions in lung cancer. A range of interventions were identified showing improvements in several ...