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

NCT06442891 | Completed DMC

• 3 other identifiers: UMCC 2024.016NCI-2024-03772HUM00248915
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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."

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

ARM I (relaxing acupressure)

EXPERIMENTAL

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.

Procedure: Acupressure Therapy; Other: Internet-Based Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

ARM II (sham acupressure)

PLACEBO COMPARATOR

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.

Procedure: Acupressure Therapy; Other: Internet-Based Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Interventions

Acupressure Therapy PROCEDURE

Self-administer relaxing acupressure

Also known as: Acupressure, Ischemic Compression

ARM I (relaxing acupressure)

Internet-Based Intervention OTHER

Receive access to acupressure mobile app

ARM I (relaxing acupressure); ARM II (sham acupressure)

Interview OTHER

Ancillary studies

ARM I (relaxing acupressure); ARM II (sham acupressure)

Medical Device Usage and Evaluation OTHER

Receive an AcuWand

ARM I (relaxing acupressure); ARM II (sham acupressure)

Questionnaire Administration OTHER

Ancillary studies

ARM I (relaxing acupressure); ARM II (sham acupressure)

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Acupressure; Interviews as Topic

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert Knoerl

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded to intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 4, 2024
• Study Start: October 1, 2024
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)