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Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Dirk Rades, Prof. Dr.

The present study is a multicenter, explorative, qualitative study. The primary endpoint of this study is to evaluate to which extent the collection of data with regard to pain caused by illness or treatment can be optimized using health technology solutions. For this evaluation semi-structured qualitative interviews with 8-10 patients will be conducted.

Secondary variables are the evaluation of the patients' pain experience and the general patients' willingness to collect data with regard to pain by using technological devices themselves or with support of healthcare professionals.

The present multicenter study is an explorative, qualitative study. It shall be evaluated from the patients' point of view if and how the collection of data with regard to pain, caused by illness or treatment, can be optimized using health technology solutions. A health technology solution could for example be an app for registering the intensity and localization of pain. The aim of this study is to examine, if such a solution would be accepted by patients with acute or chronic pain and how a fitting solution should be designed to meet the patients' requirements. Existing methods for pain measurement as well as possibilities for the development of new methods will be examined and evaluated during the interviews.

To arguable this issue the interviews comprise different topics like:

* the patients pain experience in everyday life, e.g. how the patients cope with pain in everyday life and how and if this is documented;
* experiences with and the thought of regular pain recording;
* an evaluation if patients tend to be willing to record their pain using technological devices by themselves or rather with support of healthcare professionals.

It is the aim to use the results of this study for the development of a new and improved version of pain registration. The results of the study will be summarized in a report and handed over to a startup company. Thereupon the startup company has the possibility to develop a technological solution that represents the patients' need at its best.

It is intended to have a balanced inclusion of at least 3 male and 3 female patients.

Qualitative Study for Pain Measurement Using Innovative Health Technology

Qualitative Study for Pain Measurement Using Innovative Health Technology (QualiPain)

Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology.

Patients were asked during a semi-structured qualitative interview, if they were impaired by pain during their daily life.

Patients were asked during a semi-structured qualitative interview, if they were satisfied with the assessment of their pain when performed by medical staff members.

Patients were asked during a semi-structured qualitative interview, if they were considering regular assessment of their pain important.

Patients were asked during a semi-structured qualitative interview, if they were already using technology for assessment of pain or other medical symptoms/outcomes (e.g. blood pressure).

Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain themselves.

Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if required by their treating physician.

Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if this was for their own interest only.

European Regional Development Fund

Zealand University Hospital

Design School Kolding

University Hospital Schleswig-Holstein

Professor Dr. med.

Patients included in this study must have had acute or chronic pain with an intensity of \>4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain).

Patients With Acute or Chronic Pain

Age, Customized

Sex: Female, Male

Caucasian

Race/Ethnicity, Customized

Germany

Region of Enrollment

Type of pain

Prof. Dr. med. Dirk Rades

Number of Participants Willing to Assess Their Pain Using Technology

Number of Participants Impaired by Pain During Daily Life

Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members

Number of Participants Considering Regular Assessment of Pain Important

Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)

Number of Participants Willing to Assess Their Pain Themselves

Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician

Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only

Overall Study

Neoplasms

Neoplasm Metastasis

Eligible participants:

* have advanced stage cancer and associated pain
* will receive up to 12 acupuncture sessions
* will attend sessions at UPMC's Center for Integrative Medicine
* will complete study assessments at each visit
* will complete a follow-up 4 to 6 weeks after their last acupuncture visit. Total study involvement will range from 16 to 18 weeks.

Acupuncture involves inserting thin needles into precise points on the body, known as acupuncture points, for therapeutic effect. Acupuncture will be provided by a licensed acupuncturist utilizing Dr. Tan's Balancing Method.

Acupuncture

Ronald M Glick, MD

Balancing Method for Pain Related to Advanced Cancer seeks to confirm the benefit of acupuncture for patients with pain related to advanced cancer.

Pain is common among patients with cancer, with estimates as high as 90% for those with advanced disease. Opioid medication, the most common treatment, has potential adverse effects including nausea and fatigue, further interfering with quality of life. Acupuncture has been studied for the treatment of cancer-related pain, with promising results in a few methodologically sound studies with small sample size. Prior studies have found beneficial effects of open treatment using a Traditional Chinese Medicine (TCM)-based acupuncture protocol and Dr. Tan's Balancing Method. This open trial seeks to confirm the benefit of acupuncture, utilizing Dr. Tan's Balancing Method, for patients with pain related to advanced cancer.

This clinical trial is a descriptive, interventional, and open-label pilot study.

Balancing Method for Pain Related to Advanced Cancer

Acupuncture for Pain Related to Advanced Cancer Using Dr. Tan's Balancing Method

Participant report of pain on average on a scale from 'no pain' (0) to "worst imaginable pain" (10). Higher scores mean worse outcome.

Participant report of symptoms in the past week on a scale from "no pain" (1) to "very severe" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

Participant report of symptoms in the past week on a scale from "not at all" (1) to "very much" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

Participant report of symptoms in the past week on a scale from "never" (1) to "always" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

Participant report of symptoms in the past week on a scale from "very poor/very much" (1) to "very good/not at all" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

Participant rating of symptom severity on a scale of -2 (much better) to 2 (much worse). Higher scores mean worse outcome. This measure assesses changes in symptoms over the course of study participation.

Participant report of treatment expectancy on a 5 point scale (1-5) ranging from "Not at all" (1) to "Very much" (5). Higher scores ("Very much") indicate higher treatment expectancy.

Participant report of the patient-provider connection on a 5 point scale ranging from "Not at all" to "Very much". Higher scores ("Very much") mean better outcome. This measure assesses a change in the patient-provider connection from the beginning of study participation to the end.

Participant report of Spirituality on a 5 point scale (1-5) ranging from "Not at all" (1) to "Very much" (5). Higher scores ("Very much") indicate higher personal spiritual belief.

Internally-developed, participant report of pain medication use. This questionnaire collects dosing/frequency information, which is used to calculate morphine equivalent dosing (MED). This information will be used to assess change in pain medication use over the course of study participation.

Internally-developed, participant report of acupuncture related adverse events. Administered in a checklist form. More selections on this form means more acupuncture related adverse events.

Captures new or worsening health problems participants have experienced since their last study visit. More selections on this form means worse outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Qualitative Study for Pain Measurement Using Innovative Health Technology	NCT03727373	Pain Measuremen... Pain, Chronic Pain, Acute Pain, Cancer		18 Years -	University Hospital Schleswig-Holstein
Balancing Method for Pain Related to Advanced Cancer	NCT04176575	Pain, Cancer Metastatic Canc... Invasive Cancer	Acupuncture	18 Years -	University of Pittsburgh

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