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

Abramson Cancer Center at Penn Medicine

Status: Withdrawn

Conditions: Insomnia

Treatments: Behavioral: Modified Assisted Relaxation Therapy; Behavioral: Assisted Relaxation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04318249

UPCC 15521

842655

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Assisted Relaxation Therapy

Experimental group

Description:

This group will be receiving an assisted relaxation therapy intervention

Treatment:

Behavioral: Assisted Relaxation Therapy

Modified Assisted Relaxation Therapy

Experimental group

Description:

This group will be receiving a modified version of an assisted relaxation therapy intervention

Treatment:

Behavioral: Assisted Relaxation Therapy

Behavioral: Modified Assisted Relaxation Therapy