An interventional study of Assisted Relaxation Therapy and Modified Assisted Relaxation Therapy in Insomnia, sponsored by Abramson Cancer Center at Penn Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
Browse Lung Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
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Exclusion Criteria:
This group will be receiving an assisted relaxation therapy intervention
Behavioral: Assisted Relaxation Therapy
This group will be receiving a modified version of an assisted relaxation therapy intervention
Behavioral: Assisted Relaxation Therapy · Behavioral: Modified Assisted Relaxation Therapy
This intervention includes using a smartphone application that helps with breathing techniques and sleep.
This intervention includes using a smartphone application that is modified to help with breathing techniques and additional sleep instructions.
Change from Baseline Sleep Onset Latency at 14 days
Changes in sleep onset latency will be measured by sleep diary.
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine