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

NCT06127784 | Recruiting

• 1 other identifier: 123657
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Survivorship

Keywords

Motivational Interviewing; Counselling; Survivorship Care Plan; Treatment Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Satisfaction with Care and Information Scale

  Baseline, 3, 6, and 12 months post-intervention

• M.D. Anderson Symptom Inventory, Head and Neck Module (MDASI-HN)

  Baseline, 3, 6, and 12 months post-intervention

• Patient Satisfaction with TSSP and Counselling SessionB

  Baseline

• Physician Satisfaction with TSSP

  Baseline

Study Arms (2)

MI Counselling

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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

Interventions

Motivational interviewing counselling session OTHER

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

Also known as: MI

MI Counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Second concurrent non-cutaneous malignancy
• Metastatic disease
• Clinically apparent cognitive impairment
• Suspected residual disease after treatment completion

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (1)

• Tran B, Dzioba A, Baker J, Mutsaers A, Nichols AC, Mendez A, Goodman CD, Palma DA, Winquist E, Irwin JD, Fung K, Stewart P, Lang P, Correa RJM, Kuruvilla S, Mitchell S, Phillips T, MacNeil SD. The SHARE study - Survivorship After Head and Neck Cancer: evaluating patient care and adherence to follow up in Ontario, Canada: study protocol for a randomized controlled trial. Trials. 2025 Dec 13. doi: 10.1186/s13063-025-09332-5. Online ahead of print.

  PMID: 41390453 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Health Behavior; Behavior

Study Officials

• Danielle MacNeil, MD, FRCSC

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Dzioba, PhD

CONTACT

519-685-8500; Agnieszka.Dzioba@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A prospective, randomized controlled trial at a single centre with 2 groups of 88 adults. The intervention group will receive a one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients delivered within a motivational interviewing counselling session with a clinical nurse specialist. The standard care group will receive standard of care treatment.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)