Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients

Not Applicable

Withdrawn

• Conditions: Insomnia
• Interventions: Behavioral: Assisted Relaxation Therapy; Behavioral: Modified Assisted Relaxation Therapy

• Registration Number: NCT04318249
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Study Start: 2023-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Assisted Relaxation Therapy	Assisted Relaxation Therapy	This group will be receiving a modified version of an assisted relaxation therapy intervention
Assisted Relaxation Therapy	Assisted Relaxation Therapy	This group will be receiving an assisted relaxation therapy intervention
Modified Assisted Relaxation Therapy	Modified Assisted Relaxation Therapy	This group will be receiving a modified version of an assisted relaxation therapy intervention

Primary Outcome Measures

Name	Time	Method
Change from Baseline Sleep Onset Latency at 14 days	14 days	Changes in sleep onset latency will be measured by sleep diary.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States