Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients

NCT04318249 | Withdrawn

• 2 other identifiers: UPCC 15521842655
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Sleep Onset Latency at 14 days

  Changes in sleep onset latency will be measured by sleep diary.

  14 days

Study Arms (2)

Assisted Relaxation Therapy

EXPERIMENTAL

This group will be receiving an assisted relaxation therapy intervention

Behavioral: Assisted Relaxation Therapy

Modified Assisted Relaxation Therapy

EXPERIMENTAL

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

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

Interventions

Assisted Relaxation Therapy BEHAVIORAL

This intervention includes using a smartphone application that helps with breathing techniques and sleep.

Assisted Relaxation Therapy; Modified Assisted Relaxation Therapy

Modified Assisted Relaxation Therapy BEHAVIORAL

This intervention includes using a smartphone application that is modified to help with breathing techniques and additional sleep instructions.

Modified Assisted Relaxation Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Lung Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 23, 2020
• Study Start: September 30, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)