Pain Management Program for Head and Neck Cancer Survivors

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help manage pain in individuals who have completed treatment for head and neck cancer. The goal is to improve physical function, mood, and quality of life using a Mobile Pain Coping Skills Training method, which includes five sessions over eight weeks. Individuals who completed cancer treatment 3-12 months ago and experience ongoing pain rated at 4 or higher on a simple pain scale may qualify to participate.

As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies and potentially enhance participants' quality of life.

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 prior data suggests that this behavioral intervention is safe for head and neck cancer survivors?

Research has shown that non-drug treatments, such as behavioral methods, are usually very safe. These approaches teach skills to handle challenges without medicine. Studies indicate they have few side effects and do not interfere with other medications. This offers a significant advantage for individuals already on other treatments. Overall, these methods are well-tolerated, making them a promising option for managing pain in head and neck cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Pain Coping Skills Training because it offers a fresh approach to managing pain for head and neck cancer survivors. Unlike traditional pain management, which often relies on medications like opioids and NSAIDs, this behavioral intervention empowers patients with skills to cope with pain through a series of supportive sessions. Delivered via mobile platforms, it provides flexibility and accessibility, allowing patients to engage with their care conveniently and potentially improving adherence and outcomes. This method not only aims to reduce pain but also enhances the overall quality of life by equipping patients with lasting skills for pain management.

What evidence suggests that this behavioral intervention is effective for pain management in head and neck cancer survivors?

Research has shown that non-drug methods, such as behavioral techniques, can help manage pain in cancer patients. These methods often include strategies that focus on coping skills and mental well-being. Studies have found that these approaches can lower pain levels and improve mood and quality of life for people with chronic pain. In this trial, participants will receive supportive care through Mobile Pain Coping Skills Training, which involves five sessions over eight weeks. For head and neck cancer survivors, using these skills has been linked to better physical health and less emotional distress. Therefore, strong evidence suggests that a program focusing on these skills could effectively help manage pain for those who have survived head and neck cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Shannon M. Nugent, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11529465/

Effectiveness of non-pharmacological interventions for pain ... I (Intervention): to systematically assess the impact of various non-pharmacological interventions on pain management among patients with cancer ...

2. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-2-2019-bb823

Pain Management Program for Head and Neck Cancer ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11403701/

Interventions to Reduce Psychosocial Burden in Head and ... The aim of this narrative review is to provide an overview of the evidence on psychosocial interventions for patients with HNC.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666379125000138

An update on non-pharmacological interventions for pain ... This review consolidates the current knowledge concerning the efficacy of non-pharmacological interventions for chronic pain. We focus on ...

5. otorhinolaryngologypl.com otorhinolaryngologypl.com/seo/article/550599/en?language=pl

Chronic Pain Management in Head and Neck Cancer ... Results: Apart from pharmacological interventions, a significant role in pain management is played by rehabilitation, psychological, and speech and...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9796901/

Interventions for head and neck cancer survivors This systematic review of studies from 2000 to 2021 of interventions targeting cancer survivors treated with curative‐intent, using MEDLINE, Embase, Emcare, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322001654

Systematic Review of Functional Outcomes in Cancer ... One RCT (n=116)25 providing a neuromuscular electrical stimulation intervention reported significantly worse swallow function in head and neck cancer survivors ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05811936

The SNAP Tool for Head and Neck Cancer Survivor ... In this randomized behavioral intervention, head and neck cancer (HNC) survivors and their caregivers (N=176 HNC survivor-caregiver dyads) will be ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11535686/

Efficacy and safety of non-pharmacological interventions ... These approaches, unlike pharmacological treatments, exhibit minimal adverse effects, without drug–drug interactions. They are a promising ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03030859

Self-Care for Head and Neck Cancer Survivors With ... This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis.