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

NCT06723041 | Recruiting

• 2 other identifiers: 24-007105NCI-2024-09813
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Associations between changes in anxiety and demographic variables

  Up to 2 weeks

• Efficacy of self-administered acupressure

  Up to 2 weeks

• Changes in anxiety-related symptoms

  Up to 2 weeks

Study Arms (2)

Arm I (true acupressure)

EXPERIMENTAL

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.

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

Arm II (sham acupressure)

SHAM COMPARATOR

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.

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

Interventions

Acupressure Therapy PROCEDURE

Undergo true acupressure

Also known as: Acupressure, Ischemic Compression

Arm I (true acupressure)

Health Promotion and Education OTHER

Receive educational handouts

Arm I (true acupressure); Arm II (sham acupressure)

Acupressure Therapy - placebo PROCEDURE

Undergo sham acupressure

Also known as: Acupressure, Ischemic Compression

Arm II (sham acupressure)

Acupressure Therapy - self-administered PROCEDURE

Undergo self-administered acupressure

Also known as: Acupressure, Ischemic Compression

Arm I (true acupressure); Arm II (sham acupressure)

Survey Administration OTHER

Ancillary studies

Arm I (true acupressure); Arm II (sham acupressure)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior experiences with acupressure, or training in acupressure points

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Acupressure; Health Promotion; Educational Status

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Elizabeth Cathcart-Rake, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Jennifer Manggaard

CONTACT

507-255-7768; Manggaard.Jennifer@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded during intervention only and unblinded following intervention completion
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)