Clinical trial NCT04318249: Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients
Official title: Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Insomnia
Keywords: Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change from Baseline Sleep Onset Latency at 14 days
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: