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

Mayo Clinic

Status: Enrolling

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Treatments: Procedure: Acupressure Therapy - self-administered; Other: Survey Administration; Procedure: Acupressure Therapy; Other: Health Promotion and Education; Procedure: Acupressure Therapy - placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06723041

NCI-2024-09813 (Registry Identifier)

24-007105 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Arm I (true acupressure)

Experimental group

Description:

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.

Treatment:

Other: Health Promotion and Education

Other: Survey Administration

Procedure: Acupressure Therapy

Procedure: Acupressure Therapy - self-administered

Arm II (sham acupressure)

Sham Comparator group

Description:

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.

Treatment:

Other: Health Promotion and Education

Procedure: Acupressure Therapy - placebo

Other: Survey Administration

Procedure: Acupressure Therapy - self-administered