Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors

A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult (AYA) Cancer Survivors

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."

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Interview; Procedure: Acupressure Therapy; Procedure: Acupressure Therapy; Other: Internet-Based Intervention; Other: Medical Device Usage and Evaluation

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.

Enrollment was increased to 45.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM I (relaxing acupressure); Patients receive access to acupressure mobile application and an AcuWand on study and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Procedure: Acupressure Therapy; Self-administer relaxing acupressure; Other Names: Acupressure; Ischemic Compression; Procedure: Acupressure Therapy; Self-administer sham acupressure; Other Names: Acupressure; Ischemic Compression; Other: Internet-Based Intervention; Receive access to acupressure mobile app; Other: Medical Device Usage and Evaluation; Receive an AcuWand
Placebo Comparator: ARM II (sham acupressure); Patients receive access to acupressure mobile application and an AcuWand and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Procedure: Acupressure Therapy; Self-administer relaxing acupressure; Other Names: Acupressure; Ischemic Compression; Procedure: Acupressure Therapy; Self-administer sham acupressure; Other Names: Acupressure; Ischemic Compression; Other: Internet-Based Intervention; Receive access to acupressure mobile app; Other: Medical Device Usage and Evaluation; Receive an AcuWand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate.	Up to 2 years
Adherence	Self-administered acupressure implementation will be feasible if 60% of participants complete the baseline and 6-week patient-reported measures and if 60% of acupressure group participants self-report acupressure practice for at least 27 minutes on at least 3 days per week. Descriptive statistics will be used to summarize adherence.	At 6 weeks
Satisfaction	Interview data will be analyzed using inductive content analysis. Perspectives of the intervention will be analyzed using inductive content analysis.	Up to week 10
Change in fatigue	Measured using the Patient Reported Outcomes Measurement Information Systems Fatigue 4a questionnaire. Results are continuously scaled and appropriately analyzed by Gaussian-based statistical models. Change in fatigue will be analyzed using a Full Information Maximum Likelihood mixed-effects linear regression model. Specifically, change from baseline will be evaluated by including fixed-effects coefficients for time, treatment, and the important interaction effects that will determine whether changes from baseline are greater in the relaxing acupressure group, relative to controls. Random Y-intercepts in the model will be incorporated to accommodate the nesting of repeated observations within subject. Change in fatigue will be analyzed using a Full Information Maximum Likelihood mixed-effects linear regression model.	At baseline and up to week 10

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Robert Knoerl, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): December 22, 2025
• Study Completion (Actual): December 22, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Interviews as Topic; Acupressure
• Other Study ID Numbers: UMCC 2024.016; NCI-2024-03772 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00248915 (Other Identifier: University of Michigan Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No