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

Not Applicable

Recruiting

• Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

• Registration Number: NCT06723041
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-09
• Study Start: 2024-12-11
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in acute anxiety	Up to 2 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Efficacy of self-administered acupressure	Up to 2 weeks	Assessed by the number of participants in each arm (true vs sham) who are willing to complete self-administered acupressure.
Changes in anxiety-related symptoms	Up to 2 weeks	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).
Associations between changes in anxiety and demographic variables	Up to 2 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States