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Trial Title:
Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors
NCT ID:
NCT06442891
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Masking description:
Patients are blinded to intervention.
Intervention:
Intervention type:
Procedure
Intervention name:
Acupressure Therapy
Description:
Self-administer relaxing acupressure
Arm group label:
ARM I (relaxing acupressure)
Other name:
Acupressure
Other name:
Ischemic Compression
Intervention type:
Procedure
Intervention name:
Acupressure Therapy
Description:
Self-administer sham acupressure
Arm group label:
ARM II (sham acupressure)
Other name:
Acupressure
Other name:
Ischemic Compression
Intervention type:
Other
Intervention name:
Internet-Based Intervention
Description:
Receive access to acupressure mobile app
Arm group label:
ARM I (relaxing acupressure)
Arm group label:
ARM II (sham acupressure)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
ARM I (relaxing acupressure)
Arm group label:
ARM II (sham acupressure)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Receive an AcuWand
Arm group label:
ARM I (relaxing acupressure)
Arm group label:
ARM II (sham acupressure)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
ARM I (relaxing acupressure)
Arm group label:
ARM II (sham acupressure)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 15 - 39 years old
- At least three months post cancer treatment (e.g., surgery, radiation or
chemotherapy). Participants receiving maintenance hormonal or targeted therapies
will be allowed to enroll as determined by the study investigator
- Report clinically relevant fatigue in the past seven days (Patient Reported Outcomes
Measurement Information Systems [PROMIS] Fatigue 4a scores ≥ 55)
- Speak / read English
- CRF started at or after the diagnosis of cancer
- Completed cancer treatment within the past five years
Exclusion Criteria:
- Diagnosis of untreated anemia, mood disorder, or hypothyroidism
- Plan to begin new pharmacological, psychological, or other treatments (i.e.,
physical therapy or dietary supplements) for CRF during the study. Although,
participants may continue usual treatments for CRF if the treatments were initiated
at least eight weeks prior to study enrollment, and the dose has not changed
- Plan to become pregnant or lactating during the study period
- Received acupressure or acupuncture in the past year
Gender:
All
Minimum age:
15 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Comprehensive Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Knoerl
Phone:
734-764-8617
Email:
rjknoerl@med.umich.edu
Investigator:
Last name:
Robert Knoerl
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06442891
