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NCT Number: NCT06442891

Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult 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."

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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 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 self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks.

Enrollment was increased to 45.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupressure therapy

Procedure

Self-administer relaxing acupressure

Other names: Acupressure, Ischemic Compression

Internet-Based Intervention

Other

Receive access to acupressure mobile app

interview

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Recruitment Rate

    Time frame: 1 year

    Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate.

  2. Number of Participants With Adherence

    Time frame: At 6 weeks

    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.

Secondary outcomes

  1. Change in Fatigue

    Time frame: baseline, 6 weeks, and 10 weeks after starting treatment

    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. Range score is 30-80 and increasing scores indicate worse symptoms.

  2. Acceptability E - Scale

    Time frame: 6 weeks after starting treatment

    Interview data will be analyzed using inductive content analysis. Perspectives of the intervention will be analyzed using inductive content analysis. (1 - 5, higher scores = greater acceptability) from the Acceptability E-Scale (Tariman et al., 2011) applies to all rows listed

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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