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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318249
Recruitment Status : Enrolling by invitation
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Nalaka Gooneratne, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Assisted Relaxation Therapy Behavioral: Modified Assisted Relaxation Therapy Not Applicable

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 called mPhenomic to monitor adherence to the study protocol. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be conducted as a parallel group, single-blinded pilot study for reducing insomnia among lung cancer patients. All subjects will participate in some form of insomnia treatment over a fourteen-day period. Participants eligible and enrolled in the study will be randomized into one of the two arms, which consist of the two different ART. Randomization and survey baseline measurements from eligible participants will occur on day -1 and the intervention period will last until day fourteen. On day thirty, two weeks post intervention(s), surveys will be emailed to participants to track any change in sleep quality, respiratory quality, and perception of sleep.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


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 called mPhenomic 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 called mPhenomic that helps with breathing techniques and sleep.

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




Primary Outcome Measures :
  1. Change from Baseline Sleep Onset Latency at 14 days [ Time Frame: 14 days ]
    Changes in sleep onset latency will be measured by sleep diary.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318249


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: Nalaka Gooneratne, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04318249    
Other Study ID Numbers: 842655
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nalaka Gooneratne, University of Pennsylvania:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Sleep Initiation and Maintenance Disorders
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders