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Recruiting NCT06723041

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

No phase Interventional Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupressure Therapy, Acupressure Therapy - placebo, Acupressure Therapy - self-administered, Health Promotion and Education.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Acupressure Therapy
    Undergo true acupressure
  • Procedure Acupressure Therapy - placebo
    Undergo sham acupressure
  • Procedure Acupressure Therapy - self-administered
    Undergo self-administered acupressure
  • Other Health Promotion and Education
    Receive educational handouts
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Change in acute anxiety [Time frame: Up to 2 weeks]
Secondary outcome measures (3)
  • Associations between changes in anxiety and demographic variables [Time frame: Up to 2 weeks]
  • Efficacy of self-administered acupressure [Time frame: Up to 2 weeks]
  • Changes in anxiety-related symptoms [Time frame: Up to 2 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06723041 · 24-007105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗