Motivational Interviewing for Head and Neck Cancers

Overseen By Agnieszka Dzioba, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Second malignancy, Metastatic disease, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 2

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how motivational interviewing, a type of counseling, can assist individuals who have survived head and neck cancer. The researchers aim to determine if a personalized care plan and motivational counseling session improve adherence to care recommendations. Participants will be divided into two groups: one will receive standard care, while the other will participate in the special counseling session. This trial suits those who completed cancer treatment 3 to 6 months ago for specific head and neck cancers and seek to improve their follow-up care. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative care strategies that could enhance their recovery journey.

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 motivational interviewing counseling sessions are safe for head and neck cancer patients?

Research has shown that motivational interviewing (MI) is a safe and well-accepted method to support cancer patients. Studies have found that MI helps individuals make lifestyle changes and meet their emotional and social needs. This approach has increased cancer screening rates and made difficult tasks easier for patients. It is also associated with better mental health and higher self-confidence in cancer patients.

No serious side effects have been reported with MI, indicating that the technique is gentle and supportive. For those considering participation in this study, MI appears to be a low-risk way to help manage the challenges of head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the motivational interviewing (MI) counseling session for head and neck cancer patients because it takes a personalized approach to survivorship care. Unlike standard treatments that primarily focus on medical interventions, this method involves a one-on-one session where patients identify their top concerns, which are then addressed with tailored advice. By empowering patients through role play and personalized guidance, this approach aims to enhance their ability to manage their symptoms and communicate effectively with healthcare providers about their needs. This patient-centered method could significantly improve the quality of life for survivors, making it a promising addition to current care strategies.

What evidence suggests that motivational interviewing counseling sessions are effective for head and neck cancer patients?

Research has shown that motivational interviewing can greatly benefit people with head and neck cancers. In this trial, participants in the MI Counselling arm will receive a motivational interviewing session, which studies have shown helps 68% of patients quit smoking—a rate much higher than usual. This approach also positively influences activities like exercise and can improve feelings of depression and confidence. It supports patients in making lifestyle changes and addressing emotional needs. Early results suggest it can lead to better adherence to care plans, which is important for improving quality of life and satisfaction with care. Meanwhile, participants in the Standard Care arm will receive no intervention. ^{1 2 3 4 5}

Who Is on the Research Team?

Danielle MacNeil, MD, FRCSC

Principal Investigator

Department of Otolaryngology-Head & Neck Surgery, Western University Canada

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who have been treated for stage I-IVA head and neck mucosal cancer within the last 3 to 6 months. They must be willing to consent to participate and able to read and write in English.

Inclusion Criteria

I am a patient seeking to participate in a clinical trial.

You are ready to give permission after learning about the study.

I have been diagnosed with stage I-IVA cancer in my head or neck area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-6 months post-treatment

Baseline

Data collection at baseline, 3-6 months post-treatment for HNC

1 visit

1 visit (in-person)

Intervention

Motivational interviewing counseling session with a clinical nurse specialist and provision of individualized TSSPs

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for physician implementation of survivorship care recommendations and quality of life

12 months

Quarterly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Motivational interviewing counselling session

Trial Overview The study tests if a survivorship care plan (TSSP) combined with motivational interviewing by a nurse can improve care adherence compared to usual care in head and neck cancer survivors. It's a large-scale randomized controlled trial involving 304 patients.

How Is the Trial Designed?

Group I: MI Counselling Experimental Treatment 1 Intervention

An individualized treatment summary and survivorship care plan (TSSP) will be prepared within a one-hour motivational interviewing (MI) counseling session with a clinical nurse specialist. Participants will be asked to identify their top three symptom/survivorship concerns. The intervention will address symptoms/survivorship care specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists. Patient participants will engage in role play to empower them to follow-up with their healthcare provider regarding their survivorship care needs.

Group II: Standard care Active Control 1 Intervention

The standard care group will receive no intervention (no TSSP or MI counselling session).

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652272/

Motivational Interviewing interventions aiming to improve ... Cancer types. All cancers, 4, 18.2. Head and neck cancers, 2, 9.1. Breast (or mostly) cancer, 15, 68.2. Colorectal cancers, 1, 4.5. Cancer care ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378512223000130

The impact of motivational interviewing on behavioural ... Motivational interviewing had positive effects on functional tasks, PA, BMI/BW, depression and self-efficacy in people diagnosed with cancer.

3. researchgate.net researchgate.net/publication/293638076_A_systematic_review_of_Motivational_Interviewing_interventions_in_cancer_patients_and_survivors

A systematic review of Motivational Interviewing ... Conclusion: Solid evidence exists for the efficacy of MI to address lifestyle behaviors as well as the psychosocial needs of cancer patients and ...

4. hlln.info.yorku.ca hlln.info.yorku.ca/files/2020/07/Spencer.PEC_.2016.SystematicReviewofMIInterventions.pdf?x27795

A systematic review of Motivational Interviewing ... The intervention targeted patients with head or neck cancers and observed a 68% cessation rate at one year after the intervention, much higher than observed in ...

5. jdh.adha.org jdh.adha.org/content/99/3/24

Utilization of the HPV Brief Motivational Interviewing Skills ... Results Among the participants (n=51), 49% reported using MI strategies to counsel at least one patient on prevention of HPV-OPC infections and indicated high ...