Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
PROCEDUREAcupressure Therapy
Undergo true acupressure
PROCEDUREAcupressure Therapy - placebo
Undergo sham acupressure
PROCEDUREAcupressure Therapy - self-administered
Undergo self-administered acupressure
OTHERHealth Promotion and Education
Receive educational handouts
OTHERSurvey Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Patients are blinded during intervention only and unblinded following intervention completion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Backup ContactJennifer Manggaard
Outcome results
None listed