Nurse counselling and personalized survivorship care plans for head and neck cancer survivors
Survivorship After Head and Neck Cancer: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
NA · Western University, Canada · NCT06127784
This trial will try a nurse-led motivational counselling session combined with a personalized treatment summary and survivorship care plan to help people 3-6 months after head and neck cancer treatment follow recommended care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University, Canada (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06127784 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will assign about 180 patients treated for stage I–IVA head and neck mucosal cancer to either usual care or an intervention combining a survivorship care nurse motivational interviewing session with individualized treatment summary and survivorship care plans (TSSPs) delivered to patients and their providers. Data will be collected at baseline (3–6 months post-treatment) and at 3, 6, and 12 months post-baseline with quarterly patient surveys to track outcomes. The primary outcome is physician implementation of survivorship care recommendations over 12 months, and secondary outcomes include adherence to follow-up schedules, quality of life, patient satisfaction, and feedback on the TSSP and counselling. The intervention builds on a small pilot at the same center that demonstrated feasibility and a higher rate of physician implementation.
Who should consider this trial
Good fit: Adults (age ≥18) treated for stage I–IVA head and neck mucosal cancer who are 3–6 months past their last definitive treatment and can read and speak English are ideal candidates.
Not a fit: Patients with metastatic disease, a second concurrent non-cutaneous malignancy, clinically apparent cognitive impairment, or suspected residual disease are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase clinician follow-through on survivorship needs and improve patient adherence to recommended follow-up and supportive care.
How similar studies have performed: A pilot randomized feasibility trial at the London Regional Cancer Program with 18 patients showed feasibility and a 15% higher rate of physician implementation (40% vs 25%) for the intervention arm, providing preliminary but limited evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Participants Inclusion Criteria: * Age 18 years or older * Willing to provide informed consent * Diagnosis of stage I-IVA head and neck mucosal cancer (larynx, hypopharynx, oral cavity, oropharynx, nasopharynx) * Last definitive treatment (surgery, chemotherapy, radiotherapy) between 3 and 6 months prior to enrollment * English speaking, reading and writing Exclusion Criteria: * Second concurrent non-cutaneous malignancy * Metastatic disease * Clinically apparent cognitive impairment * Suspected residual disease after treatment completion
Where this trial is running
London, Ontario
- Victoria Hospital, London Health Sciences Centre — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Danielle MacNeil, MD, FRCSC — Department of Otolaryngology-Head & Neck Surgery, Western University Canada
- Study coordinator: Agnieszka Dzioba, PhD
- Email: Agnieszka.Dzioba@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer, Survivorship, Motivational Interviewing, Counselling, Survivorship Care Plan, Treatment Adherence