Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442891
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-30
Brief Title:
Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult AYA Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-10
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 clinical trial tests the feasibility of self-administered relaxing acupressure on fatigue in adolescent and young adult AYA cancer survivors Acupressure a type of complementary or alternative medicine is the application of pressure or localized massage to specific sites on the body to control symptoms Relaxing acupressure has been shown to improve cancer-related fatigue CRF in adults however less is known about the impact of relaxing acupressure on CRF in AYA cancer survivors
Detailed Description:
PRIMARY OBJECTIVE
I Determine the feasibility of implementing a randomized controlled trial of a six-week self-administered relaxing acupressure intervention in AYA cancer survivors with clinically relevant CRF
SECONDARY OBJECTIVE
I Explore participants perspectives of acceptability and satisfaction with the six-week acupressure interventions using semi-structured interviews
EXPLORATORY OBJECTIVE
I Determine the preliminary efficacy of a six-week virtual self-administered relaxing acupressure intervention on clinically significant changes in CRF in post-treatment AYA cancer survivors
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive access to an acupressure mobile application and an AcuWand on study and self-administer relaxing acupressure to 9 acupoints over 27 minutes once daily QD for 6 weeks
ARM II Patients receive access to an acupressure mobile application and an AcuWand and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks
I Determine the feasibility of implementing a randomized controlled trial of a six-week self-administered relaxing acupressure intervention in AYA cancer survivors with clinically relevant CRF
SECONDARY OBJECTIVE
I Explore participants perspectives of acceptability and satisfaction with the six-week acupressure interventions using semi-structured interviews
EXPLORATORY OBJECTIVE
I Determine the preliminary efficacy of a six-week virtual self-administered relaxing acupressure intervention on clinically significant changes in CRF in post-treatment AYA cancer survivors
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive access to an acupressure mobile application and an AcuWand on study and self-administer relaxing acupressure to 9 acupoints over 27 minutes once daily QD for 6 weeks
ARM II Patients receive access to an acupressure mobile application and an AcuWand and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks
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 |
|---|---|---|---|
| HUM00248915 | OTHER | University of Michigan Comprehensive Cancer Center | None |
| NCI-2024-03772 | REGISTRY | None | None |