Pain Management Program for Head and Neck Cancer Survivors

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Hospice, Hearing/visual issues, Cognitive, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for pain management in head and neck cancer survivors?

The research highlights that pain is a significant issue for head and neck cancer patients, often requiring a combination of treatments, including behavioral and lifestyle interventions, to manage effectively. Although the specific trial data is not provided, the use of multimodal approaches, which include non-drug therapies like behavioral interventions, is recommended for managing chronic pain in these patients. ^{1 2 3 4 5}

How is the Behavioral Intervention treatment for head and neck cancer survivors different from other treatments?

The Behavioral Intervention for head and neck cancer survivors is unique because it focuses on non-drug methods like lifestyle changes and behavioral therapy to manage pain, unlike traditional treatments that often rely on medications. This approach can help address pain without the side effects associated with drugs, making it a novel option for those who prefer or require non-pharmacological methods. ^{2 4 6 7 8}

What is the purpose of this trial?

This clinical trial improves an existing pain management program and tests its effect on head and neck cancer survivors. This trial aims to find a better program to improve pain-related physical functioning, mood, and quality of life in a sample of individuals who have undergone treatment for head and neck cancer.

Research Team

Shannon M. Nugent, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I have experienced significant pain twice, three weeks apart, after my cancer treatment ended.

I was treated for head and neck cancer at the VA or OHSU and finished treatment 3-12 months ago.

I am experiencing pain at a level of 4 or higher on a scale of 0 to 10.

Exclusion Criteria

I do not have major hearing or vision problems that would stop me from joining.

I have only had surgery for my head or neck cancer.

Have untreated severe psychiatric illness that would impact the ability to consent and participate in the intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks

8 weeks

5 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Treatment Details

Interventions

• Behavioral Intervention

Trial Overview 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.

Participant Groups

Group I: Supportive care (Mobile Pain Coping Skills Training) Experimental Treatment 3 Interventions

Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Findings from Research

Patients with head and neck cancer commonly experience chronic pain, making it essential for healthcare providers to recognize and address these pain syndromes effectively.

A multimodal approach to treating chronic pain is recommended, which includes analgesic medications, adjuvant therapies like antidepressants and anticonvulsants, interventional techniques, and integrative medicine strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Pain Management in Head and Neck Oncology. Blasco, MA., Cordero, J., Dundar, Y.[2021]

Pain from head and neck cancer, primarily caused by oral mucositis due to chemotherapy and radiation, affects 80% of patients and significantly reduces their quality of life by making it difficult to speak, eat, and swallow.

A consensus of 30 statements on pain management was developed by a multidisciplinary group of specialists, highlighting the need for better recognition and treatment of pain in head and neck cancer patients to improve treatment compliance and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Mirabile, A., Airoldi, M., Ripamonti, C., et al.[2022]

In a study of 2,331 head and neck cancer patients, 36.76% reported pain, with White patients experiencing longer resolution times for pain incidents compared to non-White patients (99.6 minutes vs. 74.9 minutes).

White patients were significantly more likely to receive new pain prescriptions than non-White patients, highlighting disparities in pain management that could affect the quality of life for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sociodemographic Differences in Patient-Reported Pain and Pain Management of Patients With Head and Neck Cancer in a Community Oncology Setting. Canick, JE., Bhardwaj, A., Patel, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral assessment of head and neck cancer pain. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Chronic Pain Management in Head and Neck Oncology. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mechanisms of pain and their manifestations in head and neck cancer: Importance of classifying pain subtypes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sociodemographic Differences in Patient-Reported Pain and Pain Management of Patients With Head and Neck Cancer in a Community Oncology Setting. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Variations in pain prevalence, severity, and analgesic use by duration of survivorship: a cross-sectional study of 505 post-treatment head and neck cancer survivors. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pain and loss of function in head and neck cancer survivors. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Head and neck cancer survivors' pain in France: the VICAN study. [2022]