← Back to Search

Pain Management Program for Head and Neck Cancer Survivors

N/A
Recruiting
Led By Shannon M Nugent, Ph.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reported current pain of 4 or higher, using the 0-10 Numeric Pain Rating (NRS) (0='no pain' to 10='the worst pain imaginable')
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months
Awards & highlights

Study Summary

This trial improves an existing pain management program and tests its effect on head and neck cancer survivors. The goal is to find a better program to improve pain-related physical functioning, mood, and quality of life.

Who is the study for?
This trial is for head and neck cancer survivors who have completed treatment within the last 3-12 months, are experiencing pain rated at least a 4 on the Numeric Pain Rating Scale, and have felt this pain consistently. It's not suitable for those with severe hearing or vision issues, only had surgery, in hospice care, show inadequate cognitive functioning or untreated severe psychiatric illness.Check my eligibility
What is being tested?
The study tests an improved pain management program focusing on enhancing physical function related to pain, mood, and overall quality of life after head and neck cancer treatment. Participants will engage in behavioral interventions alongside assessments of their quality of life through questionnaires.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication or invasive procedures, side effects may include emotional discomfort due to discussing personal experiences with pain but are generally minimal compared to drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am experiencing pain at a level of 4 or higher on a scale of 0 to 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression
Pain coping self-efficacy
Pain-interference
Secondary outcome measures
Head and neck cancer related quality of life
Substance use
Other outcome measures
Patient acceptability
Prescription opioid dose
Prescription opioid misuse

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Hypothyroidism
2%
Hemorrhoids
2%
Blurred vision
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (Mobile Pain Coping Skills Training)Experimental Treatment3 Interventions
Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
226 Previous Clinical Trials
2,090,463 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,427 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
967 Previous Clinical Trials
6,845,646 Total Patients Enrolled

Media Library

Behavioral Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05115825 — N/A
Head and Neck Cancers Research Study Groups: Supportive care (Mobile Pain Coping Skills Training)
Head and Neck Cancers Clinical Trial 2023: Behavioral Intervention Highlights & Side Effects. Trial Name: NCT05115825 — N/A
Behavioral Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05115825 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies currently available in this clinical trial?

"Affirmative. The clinical trial registry reveals that this research, initially advertised on April 1st 2019, is currently recruiting participants. 30 patients need to be enrolled at 2 medical sites."

Answered by AI

How many volunteers have enrolled in this experiment?

"Affirmative. The details provided on clinicaltrials.gov establish that this scientific experiment, first launched in April 1st 2019, is actively seeking participants. A total of 30 persons need to be recruited from two separate medical centres."

Answered by AI
~1 spots leftby Jun 2024