Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06057636
Status:
WITHDRAWN
Last Update Posted:
2024-05-10
First Post:
2023-09-19
Brief Title:
Hypnosis for Pain in Black Women With Advanced Breast Cancer A Feasibility Study
Sponsor:
The University of Tennessee Knoxville
Organization:
The University of Tennessee Knoxville
Study Overview
Official Title:
Hypnosis for Pain in Black Women With Advanced Breast Cancer A Feasibility Study
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare two hypnotic interventions for Black women with advanced cancer pain in preparation for a well-powered phase III study The investigators plan to enroll 30 adult Black women with advanced cancer pain in a 2-arm pilot randomized controlled trial RCT
The primary aim will be to evaluate the feasibility of conducting the 2-arm clinical trial It is hypothesized that at least 75 of participants in both study arms will complete study requirements The secondary aims will be to evaluate the participants experience with the intervention and to determine the effect size of the intervention on pain severity
The primary aim will be to evaluate the feasibility of conducting the 2-arm clinical trial It is hypothesized that at least 75 of participants in both study arms will complete study requirements The secondary aims will be to evaluate the participants experience with the intervention and to determine the effect size of the intervention on pain severity
Detailed Description:
Envision is a randomized 2-arm mixed-methods pilot study to evaluate the feasibility of translating a promising in-person hypnosis intervention for advanced cancer pain into a culturally appropriate remotely delivered hypnosis intervention for pain in Black women with advanced cancer The study is 6 weeks long and does not require any in-person visits If a breast cancer survivor is determined eligible they will be educated on the purpose requirements and procedures If interested participants will be emailed the consent form and will schedule a virtual consentbaseline visit After consent is obtained the participant will be randomly assigned to one of two types of hypnotic relaxation to be used alongside current pain treatment using 11 randomization and given a study number The participant will complete online surveys at the virtual baseline visit An MP3 player with hypnotic relaxation audio files will be sent to the participants address and a virtual education visit will be scheduled At this second virtual visit participants will receive education about their study arm and a start date will be agreed upon for week 1 Beginning week 1 and continuing through week 6 participants will listen to their assigned hypnotic relaxation audio files daily and be asked to complete a weekly practice log Participants will also continue to meet with study staff virtually for weekly check-ins At these weekly meetings progress and adverse events will be assessed and relevant online surveys will be completed
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?:
None
Is an FDA AA801 Violation?:
None