Auricular Acupuncture in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with multiple myeloma (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.

Official Title
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Auricular Acupuncture in Patients With Multiple Myeloma

Conditions
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Multiple Myeloma, Fatigue, Pain, Depression

Intervention / Treatment
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* Other: Auricular Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with multiple myeloma (all stages) on current therapy, who suffer from persistent disease- or therapy-associated symptoms and limitations (screening by distress thermometer, score ≥ 5) Informed consent. Exclusion Criteria: medical reasons or a mental condition which, in the opinion of the investigator, does not allow the patient to participate in the study, a planned radiation therapy in the area of the skull (to avoid potential scattered radiation), a missing legally binding signature on the informed consent form, participation in another acupuncture/acupressure study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular Acupuncture<br>Intervention group: Ear acupressure is performed on both ears with permanent pellets according to the NADA (National Acupuncture Detoxification Association) protocol over a period of 8 weeks (presentation at the study center 1x/week, application of the acupressure patches there; these remain on both ears for 5 days and should be massaged 3x/day by the patients themselves according to the instructions provided). In addition, patients receive a 30-minute psychoeducational talk at the first treatment appointment to promote their own health competence. | Other: Auricular Acupuncture<br>* Within the NADA protocol, 5 defined points on the patient's ears are treated according to a standardized concept (shen men, kidney, lung, liver, vegetative I).<br>|
| No Intervention: Waitlist<br>Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease-specific quality of life (FACT-MM) | The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself. The diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study. | after 8 weeks (end of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety and depressiveness | The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale. | fourth week of intervention | 
| Change in anxiety and depressiveness | The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale. | after 8 weeks (end of intervention) | 
| Change in anxiety and depressiveness | The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale. | 2 weeks post-intervention | 
| Change in anxiety and depressiveness | The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale. | 12 weeks post-intervention | 
| Change of individual symptom burden | Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale. | fourth week of intervention | 
| Change of individual symptom burden | Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale. | after 8 weeks (end of intervention) | 
| Change of pain | Improvement of pain (FACT-MM) questionnaire | fourth week of intervention | 
| Change of pain | Improvement of pain (FACT-MM) questionnaire | after 8 weeks (end of intervention) | 
| Change of pain | Improvement of pain (FACT-MM) questionnaire | 2 weeks post-intervention | 
| Change of pain | Improvement of pain (FACT-MM) questionnaire | 12 weeks post-intervention | 
| Change of Fatigue | The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions. | fourth week of intervention | 
| Change of Fatigue | The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions. | after 8 weeks (end of intervention) | 
| Change of Fatigue | The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions. | 2 weeks post-intervention | 
| Change of Fatigue | The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions. | 12 weeks post-intervention | 
| Change of sleep disorders and sleep quality | The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval | fourth week of intervention | 
| Change of sleep disorders and sleep quality | The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval | after 8 weeks (end of intervention) | 
| Change of sleep disorders and sleep quality | The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval | 2 weeks post-intervention | 
| Change of sleep disorders and sleep quality | The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval | 12 weeks post-intervention | 
| Number of pateints with adverse events | Tolerability of the application | through study completion, an average of 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auricular Acupuncture