Pain Sensitivity and Unpleasantness in People with Alzheimer’s Disease and/or Cancer

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    100
  • sponsor
    NIA
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Updated on 3 April 2023
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Summary

The University of Tennessee Health Science Center in Memphis, TN has a research opportunity for people to participate in the study: Pain Sensitivity and Unpleasantness in People with Alzheimer’s Disease and Cancer. Specifically, they are looking for individuals over the age of 60 for 1 of 3 groups: (1) those with Alzheimer’s Disease only, (2) those with cancer only, (3) those with both Alzheimer’s Disease and cancer. The purpose of this study is to examine how men and women over the age of 60 with Alzheimer's disease and/or cancer might process and/or respond to pain or discomfort. Participants and their caregivers may receive up to $250.00 each for participating in the study. Participation may include completing various questionnaires over the phone, once a week for up to 7 weeks with one optional in-person session.

Description

There are two parts to this study: one that can be completed all over the phone and one optional in person testing day. The first part consists of consent and eligibility screening and takes place over the phone. If you are eligible to enroll in the study, and choose to continue, we will ask you and your a caregiver questions about education and income, thinking and memory, and depression and anxiety. This will take 1-2 hours on a single day. We will then ask you and your caregiver to answer questionnaires once weekly for six weeks. We will ask you some questions to learn about your general health, medications, and your current levels of pain. These follow up phone calls last for about 15 minutes. This information may be collected using REDCap, a secure, web -based, HIPAA-compliant, data collection platform or over the phone and study personnel will record responses. The in-person testing lasts about an hour and a half and consists of measuring how you respond to pain produced by applying heat or pressure to the palm of your hand. We will gather your responses to heat and pressure separately. For this part, we will place a small device that heats up or creates pressure on your palm and then ask you to tell us when you feel just noticeable pain, mild pain, and moderate pain. We will stop the device once you tell us you feel moderate pain. We will repeat the pain test a few times so that we can average your responses. After that, we will do some additional tests of the heat or pressure pain that will be based on your responses to when you noticed the different levels of pain. You can stop the heating or pressure anytime and you can stop the study anytime by just letting us know. Finally, you will be asked to rate your pain in response to tapping pressure from a thin plastic filament. It's just a plastic thread and cannot break your skin. Again, you can stop testing at any time. Based on preference, availability, and geographic region, we are accepting participants for either one or both parts of our study. Both participants and their caregivers will be eligible for up to $250.00 for study completion. If you are interested in learning more about our study, please contact Lauren Beliveau at 901-448-5490 or Lbelivea@uthsc.edu for additional information. Please note that this does not automatically enroll you in our study.

Details
Condition Alzheimer’s Disease, Cancer
Clinical Study IdentifierTX306124
SponsorNIA
Last Modified on3 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

years or older
English speaking
Able to see and hear (either with or without glasses / hearing aids)
Verbally communicative (able to talk on the phone)
Either: AD, cancer, or both AD + cancer
Study partner/caregiver to participate with them

Exclusion Criteria

Dementia diagnosis other than Alzheimer’s disease
Residual sensory deficits from a stroke
Peripheral neuropathy in an upper extremity
Unstable cardiovascular disorder
Alcohol or drug use disorder within the past 6 months
Major psychiatric disorder within the past 6 weeks
Uncontrolled hypertension/high blood pressure
Known brain metastasis
Brain Cancer
(Plus additional eligibility screening over the phone)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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