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

NCT ID: NCT06723041

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-11

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Patients are blinded during intervention only and unblinded following intervention completion

Study Groups

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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.

Group Type EXPERIMENTAL

Acupressure Therapy

Intervention Type PROCEDURE

Undergo true acupressure

Acupressure Therapy - self-administered

Intervention Type PROCEDURE

Undergo self-administered acupressure

Health Promotion and Education

Intervention Type OTHER

Receive educational handouts

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type SHAM_COMPARATOR

Acupressure Therapy - placebo

Intervention Type PROCEDURE

Undergo sham acupressure

Acupressure Therapy - self-administered

Intervention Type PROCEDURE

Undergo self-administered acupressure

Health Promotion and Education

Intervention Type OTHER

Receive educational handouts

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Acupressure Therapy

Undergo true acupressure

Intervention Type PROCEDURE

Acupressure Therapy - placebo

Undergo sham acupressure

Intervention Type PROCEDURE

Acupressure Therapy - self-administered

Undergo self-administered acupressure

Intervention Type PROCEDURE

Health Promotion and Education

Receive educational handouts

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Acupressure Ischemic Compression Acupressure Ischemic Compression Acupressure Ischemic Compression

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Cathcart-Rake, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: [email protected]

Jennifer Manggaard

Role: CONTACT

Phone: 507-255-7768

Email: [email protected]

Facility Contacts

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Clinical Trials Referral Office

Role: primary

Jennifer Manggaard

Role: backup

Related Links

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Other Identifiers

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NCI-2024-09813

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-007105

Identifier Type: OTHER

Identifier Source: secondary_id

24-007105

Identifier Type: -

Identifier Source: org_study_id