Ignite Creation Date:
2024-05-06 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05304793
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2022-03-03
Brief Title:
Testing a Cognitive Behavioral Model for Reducing Dyspnea in Patients With Lung Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study to Test a Cognitive-Behavioral Model for Dyspnea in Patients With Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies the effect of a form of cognitive-behavioral therapy Take a Breath on reducing the intensity and frequency of dyspnea difficulty breathing in patients with lung cancer Take a Breath consists of individual therapy sessions that educate patients on dyspnea and provides coping strategies
Detailed Description:
PRIMARY OBJECTIVE
I To determine the acceptability based on patient satisfaction tolerability based on rate of symptom exacerbation from pre- to post-treatment and feasibility based on number of patients agreeing to be participate adherence rate and retention rate of treatment of Take a Breath TAB a skills-based cognitive-behavioral treatment lasting 4 weekly hour-long sessions targeting dyspnea and related distress and impairment in adults with lung cancer N40
SECONDARY OBJECTIVES
I To provide preliminary data on the effectiveness of TAB on dyspnea and related distress and impairment
II To test cognitive-behavioral variables physical symptoms thoughts behaviors and emotions as predictors of dyspnea severity and anxiety sensitivity as a moderator
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients participate in 4 weekly TAB in-person or video conference sessions over 1 hour each that provide them with skills to cope with their dyspnea Patients also receive treatment handouts a compact disk CD with an audio file with instructions for progressive muscle relaxation and a pulse oximeter Patients may receive additional support calls over 10-15 minutes from the TAB provider within 1 week following each session
ARM II Patients receive usual management of dyspnea from the treating physician
After completion of study patients are followed up at 1 month
I To determine the acceptability based on patient satisfaction tolerability based on rate of symptom exacerbation from pre- to post-treatment and feasibility based on number of patients agreeing to be participate adherence rate and retention rate of treatment of Take a Breath TAB a skills-based cognitive-behavioral treatment lasting 4 weekly hour-long sessions targeting dyspnea and related distress and impairment in adults with lung cancer N40
SECONDARY OBJECTIVES
I To provide preliminary data on the effectiveness of TAB on dyspnea and related distress and impairment
II To test cognitive-behavioral variables physical symptoms thoughts behaviors and emotions as predictors of dyspnea severity and anxiety sensitivity as a moderator
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients participate in 4 weekly TAB in-person or video conference sessions over 1 hour each that provide them with skills to cope with their dyspnea Patients also receive treatment handouts a compact disk CD with an audio file with instructions for progressive muscle relaxation and a pulse oximeter Patients may receive additional support calls over 10-15 minutes from the TAB provider within 1 week following each session
ARM II Patients receive usual management of dyspnea from the treating physician
After completion of study patients are followed up at 1 month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-08108 | REGISTRY | CTRP Clinical Trial Reporting Program | None |