Acupressure for the Reduction of Anxiety in Patients Receiving Cancer-Directed Therapy

Acupressure for Anxiety: A Randomized Controlled Trial of an Acupressure Intervention for Patients Receiving Cancer-Directed Therapy

This clinicaI trial is being done to determine if acupressure is helpful to reduce anxiety related to chemotherapy, compared with "sham" (or placebo) acupressure in patients with cancer. Anxiety, experienced by many patients with cancer, can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicine ways to manage symptoms. Acupressure is the application of non-invasive finger pressure along energy points throughout the body in order to relieve pain and induce a feeling of well-being. Previous research has shown that acupressure can help both adults and children with their anxiety in certain situations, such as after surgery. Patients can be taught how to do the acupressure on themselves, making this an intervention that can be done anywhere. Acupressure is well tolerated with minimal reports of adverse reactions. Undergoing acupressure may be effective in reducing anxiety in cancer patients receiving chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Procedure: Acupressure Therapy; Procedure: Acupressure Therapy - self-administered; Other: Health Promotion and Education; Procedure: Acupressure Therapy - placebo

Detailed Description

PRIMARY OBJECTIVE:

I. To test the efficacy of a nurse-applied acupressure intervention for anxiety associated with active cancer-directed therapy.

SECONDARY OBJECTIVES:

I. To test the efficacy of a patient-applied acupressure intervention for anxiety associated with active cancer-directed therapy.

II. To assess whether acupressure appears to improve nausea related to cancer and cancer-directed therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least twice daily (BID) for seven days.

ARM II: Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Jennifer Manggaard; Phone Number: 507-255-7768; Email: Manggaard.Jennifer@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Jennifer Manggaard; Phone Number: 507-255-7768; Email: Manggaard.Jennifer@mayo.edu
      • Principal Investigator: Elizabeth Cathcart-Rake, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• NURSE-LED INTERVENTION: Age >= 18 years and be diagnosed with cancer
• NURSE-LED INTERVENTION: Undergoing systemic, antineoplastic therapy
• NURSE-LED INTERVENTION: Ability to provide oral consent
• NURSE-LED INTERVENTION: Willingness to undergo a nurse-led acupressure intervention
• NURSE-LED INTERVENTION: Willingness and ability to complete pre- and post-intervention questionnaires in English
• NURSE-LED INTERVENTION: Report acute anxiety as a 5 or higher on a scale for 0 (no anxiety) to 10 (severe anxiety)
• SELF-ADMINISTRATION INTERVENTION: Age >= 18 years and be diagnosed with cancer
• SELF-ADMINISTRATION INTERVENTION: Undergoing systemic, antineoplastic therapy
• SELF-ADMINISTRATION INTERVENTION: Ability to provide oral consent
• SELF-ADMINISTRATION INTERVENTION: Willingness to undergo a nurse-led acupressure intervention
• SELF-ADMINISTRATION INTERVENTION: Willingness and ability to complete pre- and post-intervention questionnaires in English
• SELF-ADMINISTRATION INTERVENTION: Report acute anxiety as a 5 or higher on a scale for 0 (no anxiety) to 10 (severe anxiety)
• SELF-ADMINISTRATION INTERVENTION: Reports 2+/day anxiety episodes at home
• SELF-ADMINISTRATION INTERVENTION: Interested in learning self-administered acupressure

Exclusion Criteria:

• Prior experiences with acupressure, or training in acupressure points

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 (true acupressure); Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.	Other: Survey Administration; Ancillary studies; Procedure: Acupressure Therapy; Undergo true acupressure; Other Names: Acupressure; Ischemic Compression; Procedure: Acupressure Therapy - self-administered; Undergo self-administered acupressure; Other Names: Acupressure; Ischemic Compression; Other: Health Promotion and Education; Receive educational handouts
Sham Comparator: Arm II (sham acupressure); Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.	Other: Survey Administration; Ancillary studies; Procedure: Acupressure Therapy - self-administered; Undergo self-administered acupressure; Other Names: Acupressure; Ischemic Compression; Other: Health Promotion and Education; Receive educational handouts; Procedure: Acupressure Therapy - placebo; Undergo sham acupressure; Other Names: Acupressure; Ischemic Compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in acute anxiety	Will be compared between treatment groups. This will be measured by changes in responses to a single item, "Please rate the following symptoms, based on how you feel at the current time (please indicate the one most correct response)," with responses provided on a Likert scale from 0 (no anxiety) to 10 (worst possible anxiety).	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associations between changes in anxiety and demographic variables	Demographic variables, including age, gender identity, race/ethnicity, cancer type, cancer stage, and cancer therapy type, will be compared with answers to anxiety question specified in Outcome 1.	Up to 2 weeks
Efficacy of self-administered acupressure	Assessed by the number of participants in each arm (true vs sham) who are willing to complete self-administered acupressure.	Up to 2 weeks
Changes in anxiety-related symptoms	Assessed using an anxiety questionnaire administered at baseline and post-intervention. Seven items (anxiety, nausea, pain, wellbeing, relaxation, worry, and distress) are rated on a scale of 0 (strongly disagree) to 10 (strongly agree).	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Elizabeth Cathcart-Rake, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Health Education; Educational Status; Acupressure; Health Promotion
• Other Study ID Numbers: 24-007105 (Mayo Clinic Institutional Review Board); NCI-2024-09813 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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