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Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

Primary Purpose

Head and Neck Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Counseling
Electroencephalography
Neurofeedback
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of HNC, with patient scheduled to receive radiation therapy, with or without evidence of active disease
  • Willingness to be seen in the outpatient supportive care center (SCC)
  • History of use of non-medical opioid use (Screener and Opioid Assessment for Patients with Pain [SOAPP] >= 7+ and/or Cut Down, Annoyed, Guilty, and Eye opener questionnaire [CAGE] >= 2+)
  • Physician-estimated prognosis of at least 12 months
  • Age 18 or older
  • Able to complete study assessments
  • Willing to sign written informed consent
  • Both human papillomavirus (HPV) and non-HPV patients will be included
  • Patients currently receiving opioids for at least 1 week
  • Able to read, write and speak English

Exclusion Criteria:

  • Individual with clinically evident impaired cognition by Memorial Delirium Assessment Scale (MDAS) score of >= 13
  • Employees of MD Anderson Cancer Center

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ARM I (CHAT)

ARM II (NFB)

ARM III (SOC)

Arm Description

Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Outcomes

Primary Outcome Measures

Frequency of non-medical opioid use (NMOU) behaviors
Composite NMOU score is calculated by summing the number of times each behavior suggestive of NMOU is recorded.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
August 23, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05077072
Brief Title
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients
Official Title
Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial compares different pain management interventions (standard of care [SOC], neurofeedback [NFB] training, and compassionate high alert team [CHAT]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.
Detailed Description
PRIMARY OBJECTIVE: I. To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups. SECONDARY OBJECTIVES: I. To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC. II. Examine the pain severity (area under the curve [AUC]), daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD), and mood (Hospital Anxiety and Depression Scale, HADS) for each of the treatment arms (CHAT, NFB, or SOC) in head and neck cancer (HNC) patients receiving radiation therapy at the end of 3 months. EXPLORATORY OBJECTIVE: I. To examine the cortical and subcortical regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which changes in electroencephalogram (EEG) patterns mediate the effects of the intervention. OUTLINE: Patients are randomized into 1 of 3 arms. ARM I: Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks. ARM II: Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks. ARM III: Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM I (CHAT)
Arm Type
Experimental
Arm Description
Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.
Arm Title
ARM II (NFB)
Arm Type
Experimental
Arm Description
Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.
Arm Title
ARM III (SOC)
Arm Type
Active Comparator
Arm Description
Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive SOC
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Participate in CHAT counseling intervention
Intervention Type
Procedure
Intervention Name(s)
Electroencephalography
Other Intervention Name(s)
EEG, electroencephalogram
Intervention Description
Undergo EEG
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
EEG biofeedback
Intervention Description
Undergo NFB intervention
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Frequency of non-medical opioid use (NMOU) behaviors
Description
Composite NMOU score is calculated by summing the number of times each behavior suggestive of NMOU is recorded.
Time Frame
through study completion, an average of a year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of HNC, with patient scheduled to receive radiation therapy, with or without evidence of active disease Willingness to be seen in the outpatient supportive care center (SCC) History of use of non-medical opioid use (Screener and Opioid Assessment for Patients with Pain [SOAPP] >= 7+ and/or Cut Down, Annoyed, Guilty, and Eye opener questionnaire [CAGE] >= 2+) Physician-estimated prognosis of at least 12 months Age 18 or older Able to complete study assessments Willing to sign written informed consent Both human papillomavirus (HPV) and non-HPV patients will be included Patients currently receiving opioids for at least 1 week Able to read, write and speak English Exclusion Criteria: Individual with clinically evident impaired cognition by Memorial Delirium Assessment Scale (MDAS) score of >= 13 Employees of MD Anderson Cancer Center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Yennu
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sriram Yennu
Phone
713-792-6085
Email
syennu@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Sriram Yennu

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

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