Clinical trial NCT06723041: Acupressure for the Reduction of Anxiety in Patients Receiving Cancer-Directed Therapy
Official title: Acupressure for Anxiety: a Randomized Controlled Trial of an Acupressure Intervention for Patients Receiving Cancer-Directed Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in acute anxiety
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Associations between changes in anxiety and demographic variables
timeFrame: Up to 2 weeks
measure: Efficacy of self-administered acupressure
timeFrame: Up to 2 weeks
measure: Changes in anxiety-related symptoms
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Elizabeth Cathcart-Rake, MD
role: PRINCIPAL_INVESTIGATOR
References: