Survivorship After HNC: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up

Survivorship After Head and Neck Cancer: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up

Treatment summary and survivorship care plans (TSSPs) are poorly studied in Head and Neck Cancer (HNC) patients, and given the high frequency of unmet needs, this patient population has potentially the most to benefit from the implementation of TSSPs. A preliminary feasibility randomized control trial (RCT) at London Regional Cancer Program (LRCP) of 18 patients with HNC evaluating the implementation of TSSPs, found that patients assigned to the intervention group had a 15% higher rate of physician implementation of survivorship care needs compared to the usual care group (40% versus 25%, respectively). Results of the pilot study indicated that successful execution of TSSPs and counselling sessions for HNC patients is feasible. In follow up to the initial feasibility trial, the present investigation seeks to execute a large-scale randomized controlled trial. Three hundred and four patients who were treated at the London Regional Cancer Program (LRCP) for HNC will be randomly assigned to either usual care or a survivorship care plan (TSSP) intervention (90 patients in each arm). The intervention will consist of the delivery of a TSSP and a motivational interviewing counseling session with a clinical nurse specialist tailored to the needs of this vulnerable cancer population. The primary objective of the study is to evaluate the delivery of a TSSP during a one-on-one motivational interviewing counselling session with HNC survivors to determine whether the intervention results in improved implementation of recommendations for HNC survivors compared to usual care. Secondary study objectives will evaluate quality of life and satisfaction with care at 12 months post-intervention between the usual care and intervention group. Primary care providers of patients assigned to the intervention group will also be surveyed on the utility of the TSSP.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Survivorship
• Intervention / Treatment: Other: Motivational interviewing counselling session

Detailed Description

This study is a longitudinal randomized controlled trial. Patients will be randomly assigned to either usual treatment or the intervention (MI counselling session). Data will be collected at four time points: baseline (3-6 months post-treatment for HNC), and 3-, 6- and 12- months post-baseline visit. 180 patients with curable stage I-IV head and neck mucosal cancer (HNC) will be recruited to the study (90 per arm).

The intervention will consist of a survivorship care nurse motivational interviewing counseling session coupled with the provision of individualized TSSPs to patients and their health care providers.

The primary outcome will be physician implementation of survivorship care recommendations over the course of 12 months post-intervention assessed by quarterly patient surveys. Secondary outcomes will include adherence to recommended follow-up schedules, quality of life using validated measures, patient satisfaction with care, patient feedback on the utility of the TSSP and counselling session and physician feedback on the utility of the TSSP.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnieszka Dzioba, PhD; Phone Number: 519-685-8500; Email: Agnieszka.Dzioba@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • Victoria Hospital, London Health Sciences Centre
      • Contact: Julie Strychowsky; Phone Number: 5196704100; Email: Julie.Strychowsky@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MI Counselling; 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.	Other: Motivational interviewing counselling session; Individually tailored treatment summary and survivorship care plan provided within a 1-hour 1 hour counseling session with a clinical nurse specialist; Other Names: MI
No Intervention: Standard care; The standard care group will receive no intervention (no TSSP or MI counselling session).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician implementation of survivorship care recommendations	Physician implementation of survivorship care recommendations over the course of 12 months post-baseline, assessed by quarterly patient reports. Proportion of recommendations implemented by the health care provider will be recorded at 3, 6, and 12-months post-baseline and compared between the intervention and standard care group.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Care and Information Scale	The Satisfaction with Care and Information Scale evaluates participants' level of satisfaction with information provided to them on diagnosis and treatment-related issues, and survivorship issues, using a 5- point Likert scale (1 = very dissatisfied; 5 = very satisfied, range 1 to 5). The means of the responses are calculated to generate satisfaction scores for the following domains: Diagnosis, Oral/dental care, Long-term effects after treatment, Neck/shoulder mobility, Eating/speaking, Post-treatment care, Family/close relationships, and, Overall satisfaction with care and information.	Baseline, 3, 6, and 12 months post-intervention
M.D. Anderson Symptom Inventory, Head and Neck Module (MDASI-HN)	The MDASI-HN includes a total of 28 items, with sub-scales, including a 13-item core cancer symptoms subscale, a 9-item head and neck-specific symptom subscale, and 6-items assessing the extent that symptoms interfere with daily living. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely).	Baseline, 3, 6, and 12 months post-intervention
Patient Satisfaction with TSSP and Counselling SessionB	Investigator developed survey evaluating patient satisfaction with and feedback on the utility of the TSSP and motivational interviewing counseling session	Baseline
Physician Satisfaction with TSSP	Investigator developed survey evaluating physician (primary care provider and oncologist) feedback on the utility of the TSSP in addressing head and neck cancer survivorship needs.	Baseline

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Danielle MacNeil, MD, FRCSC, Department of Otolaryngology-Head & Neck Surgery, Western University Canada

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Treatment Adherence; Counselling; Survivorship Care Plan
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavior; Health Behavior; Head and Neck Neoplasms; Treatment Adherence and Compliance
• Other Study ID Numbers: 123657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be made available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No