RecruitingNot ApplicableNCT06127784

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


Sponsor

Western University, Canada

Enrollment

176 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating a structured cancer survivorship care program for people who have completed treatment for head and neck cancer, to see if it improves patients' ability to stick with follow-up appointments and improves their overall care experience. **You may be eligible if:** - You are 18 or older - You have been diagnosed with Stage I–IVA head and neck mucosal cancer (larynx, hypopharynx, oral cavity, oropharynx, or nasopharynx) - Your last definitive treatment (surgery, chemo, or radiation) was between 3 and 6 months ago - You can read, write, and speak English **You may NOT be eligible if:** - You have a second active non-skin cancer - Your cancer has spread to distant sites (metastatic disease) - You have clinically apparent cognitive impairment - There is suspicion of residual cancer after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMotivational 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


Locations(1)

Victoria Hospital, London Health Sciences Centre

London, Ontario, Canada

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NCT06127784


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