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

University of Michigan Rogel Cancer Center42 enrolled

Overview

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."

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Interventions

Acupressure TherapyPROCEDURE

Self-administer relaxing acupressure

Acupressure TherapyPROCEDURE

Self-administer sham acupressure

Internet-Based InterventionOTHER

Receive access to acupressure mobile app

InterviewOTHER

Ancillary studies

Medical Device Usage and EvaluationOTHER

Receive an AcuWand

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 15 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At 6 weeks

Satisfaction

Interview data will be analyzed using inductive content analysis. Perspectives of the intervention will be analyzed using inductive content analysis.

Time frame: 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.

Time frame: At baseline and up to week 10