Behavioral Relaxation Approaches for Insomnia in Lung Can... | NCT04318249

Studies
Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients

NCT04318249

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Withdrawn

Last Update Posted

Nov 25, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Insomnia

Interventions

Assisted Relaxation Therapy
Modified Assisted Relaxation Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
842655	Other Identifier	University of Pennsylvania IRB

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to recruit subjects

Expanded Access Info

Start Date

Sep 30, 2023Estimated

Primary Completion Date

Apr 1, 2026Estimated

Completion Date

Apr 1, 2027Estimated

First Submitted Date

Mar 18, 2020

First Submission Date that Met QC Criteria

Mar 19, 2020

First Posted Date

Mar 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2024

Last Update Posted Date

Nov 25, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nalaka Gooneratne, Principal Investigator, Abramson Cancer Center at Penn MedicinePrincipal Investigator

Lead Sponsor

Abramson Cancer Center at Penn MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Assisted Relaxation Therapy	Behavioral	This intervention includes using a smartphone application that helps with breathing techniques and sleep.	Assisted Relaxation Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline Sleep Onset Latency at 14 days	Changes in sleep onset latency will be measured by sleep diary.	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.