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RECRUITING
NCT06127784
NA

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

Sponsor: Western University, Canada

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2025-05-01

Completion Date

2027-07-01

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

OTHER

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

Locations (1)

Victoria Hospital, London Health Sciences Centre

London, Ontario, Canada