Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients

Insomnia Clinical Trial

— LC_ART  

Official title:

Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04318249
• Other study ID #: 842655
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: September 2022
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: Nalaka S Gooneratne, MD
• Phone: 215-573-2048
• Email: ngoonera[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18 or older

• Diagnosed with Lung Cancer (In remission, Undergoing Immune Modulated Chemotherapy, Undergoing Platinum-based Chemotherapy

• Fluent in English

• Has Access to Smartphone

• Has internet connection at home

• More than 4 weeks post-surgery

Exclusion Criteria:

• Inability to speak English or communicate verbally

• Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the guided compassion training due to deafness)

Related Conditions & MeSH terms

• Insomnia
• Lung Neoplasms
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Assisted Relaxation Therapy
This intervention includes using a smartphone application that helps with breathing techniques and sleep.
• Modified Assisted Relaxation Therapy
This intervention includes using a smartphone application that is modified to help with breathing techniques and additional sleep instructions.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Sleep Onset Latency at 14 days	Changes in sleep onset latency will be measured by sleep diary.	14 days