Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients (LC_ART)
Primary Purpose
Insomnia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assisted Relaxation Therapy
Modified Assisted Relaxation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Lung Cancer
Eligibility 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)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Assisted Relaxation Therapy
Modified Assisted Relaxation Therapy
Arm Description
This group will be receiving an assisted relaxation therapy intervention
This group will be receiving a modified version of an assisted relaxation therapy intervention
Outcomes
Primary Outcome Measures
Change from Baseline Sleep Onset Latency at 14 days
Changes in sleep onset latency will be measured by sleep diary.
Secondary Outcome Measures
Full Information
NCT ID
NCT04318249
First Posted
March 18, 2020
Last Updated
September 2, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04318249
Brief Title
Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients
Acronym
LC_ART
Official Title
Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assisted Relaxation Therapy
Arm Type
Experimental
Arm Description
This group will be receiving an assisted relaxation therapy intervention
Arm Title
Modified Assisted Relaxation Therapy
Arm Type
Experimental
Arm Description
This group will be receiving a modified version of an assisted relaxation therapy intervention
Intervention Type
Behavioral
Intervention Name(s)
Assisted Relaxation Therapy
Intervention Description
This intervention includes using a smartphone application that helps with breathing techniques and sleep.
Intervention Type
Behavioral
Intervention Name(s)
Modified Assisted Relaxation Therapy
Intervention Description
This intervention includes using a smartphone application that is modified to help with breathing techniques and additional sleep instructions.
Primary Outcome Measure Information:
Title
Change from Baseline Sleep Onset Latency at 14 days
Description
Changes in sleep onset latency will be measured by sleep diary.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nalaka S Gooneratne, MD
Phone
215-573-2048
Email
ngoonera@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients
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