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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06442891

UMCC 2024.016

HUM00248915 (Other Identifier)

NCI-2024-03772 (Registry Identifier)

Details and patient eligibility

About

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."

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 15 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups, including a placebo group

ARM I (relaxing acupressure)

Experimental group

Description:

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.

Treatment:

Procedure: Acupressure Therapy

Procedure: Acupressure Therapy

Other: Questionnaire Administration

Other: Internet-Based Intervention

Other: Interview

Other: Medical Device Usage and Evaluation

ARM II (sham acupressure)

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Acupressure Therapy

Procedure: Acupressure Therapy

Other: Questionnaire Administration

Other: Internet-Based Intervention

Other: Interview

Other: Medical Device Usage and Evaluation