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NCT Number: NCT06127784

Survivorship After HNC: 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.

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Key information

Conditions

Head and Neck Cancer Behavior Head and Neck Neoplasms Health Behavior Neoplasms Neoplasms by Site Survivorship Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location status: Recruiting

Location contact

Julie Strychowsky

CONTACT

[email protected]

5196704100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: MI

Primary outcomes

  1. Physician implementation of survivorship care recommendations

    Time frame: 12 months

    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.

Secondary outcomes

  1. Satisfaction with Care and Information Scale

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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.

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

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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).

  3. Patient Satisfaction with TSSP and Counselling SessionB

    Time frame: Baseline

    Investigator developed survey evaluating patient satisfaction with and feedback on the utility of the TSSP and motivational interviewing counseling session

  4. Physician Satisfaction with TSSP

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka Dzioba, PhD

CONTACT

[email protected]

519-685-8500

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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