Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients (LC_ART)

November 21, 2024 updated by: Nalaka Gooneratne, Abramson Cancer Center at Penn Medicine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assisted Relaxation Therapy
This group will be receiving an assisted relaxation therapy intervention
Behavioral: Assisted Relaxation Therapy
This intervention includes using a smartphone application that helps with breathing techniques and sleep.
Experimental: Modified Assisted Relaxation Therapy
This group will be receiving a modified version of an assisted relaxation therapy intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Sleep Onset Latency at 14 days
Time Frame: 14 days
Changes in sleep onset latency will be measured by sleep diary.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 15521
  • 842655 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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