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

NCT ID: NCT06127784

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-07-01

Brief Summary

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.

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.

Conditions

Head and Neck Cancer; Survivorship

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Motivational interviewing counselling session

Intervention Type: OTHER

Individually tailored treatment summary and survivorship care plan provided within a 1-hour 1 hour counseling session with a clinical nurse specialist

Standard care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

MI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Danielle MacNeil

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danielle MacNeil, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Victoria Hospital, London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Agnieszka Dzioba, PhD

Role: CONTACT

Agnieszka.Dzioba@lhsc.on.ca

519-685-8500

Facility Contacts

Julie Strychowsky

Role: primary

Julie.Strychowsky@lhsc.on.ca

5196704100

Other Identifiers

123657

Identifier Type: -

Identifier Source: org_study_id