NCT04318249

Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, 30-day research study that is exploring the effects of two simplified mindfulness interventions in lung cancer patients aimed to improve their sleep quality and anxiety regarding sleep. The investigators will be enrolling a total of 20 patients who have insomnia symptoms. Patients will use a behavioral intervention to help with their sleep.

Detailed description

The objective is to implement and examine the outcomes of a simplified relaxation intervention, Assisted Relaxation Therapy (ART), for lung cancer patients who experience insomnia symptoms and other sleep difficulties. This intervention includes using a smartphone application. A variety of surveys will be used to track the interventions' efficacy throughout the study. To test these interventions, the investigators will recruit participants (n=20) from a weekly oncology patient list located within the University of Pennsylvania. Participants with a history of lung cancer who are recruited into the study must have a smartphone. Participants will use the ART intervention over the course of 2 weeks and will receive surveys at enrollment (D0), end of intervention (D14) and 2 weeks post-intervention (D30). Missing data will be handled using imputation methods. The investigators will analyze the data using statistical programs to determine progress throughout the study.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Assisted Relaxation Therapy	This intervention includes using a smartphone application that helps with breathing techniques and sleep.
BEHAVIORAL	Modified Assisted Relaxation Therapy	This intervention includes using a smartphone application that is modified to help with breathing techniques and additional sleep instructions.

Timeline

• Start date: 2023-09-30
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2020-03-23
• Last updated: 2024-11-25

Locations

1 site across 1 country: United States