Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06127784

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

Led by Western University, Canada · Updated on 2025-11-18

176

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Victoria Hospital, London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

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Research Team

A

Agnieszka Dzioba, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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