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Spots Global Cancer Trial Database for Survivorship After HNC: Evaluating Adherence to Follow-up

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Trial Identification

Brief Title: Survivorship After HNC: Evaluating Adherence to Follow-up

Official Title: Survivorship After Head and Neck Cancer: A Single Arm Trial Evaluating Patient Care and Adherence to Follow-up

Study ID: NCT06127784

Study Description

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 single arm trial to evaluate a TSSP and counselling intervention specifically 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 counselling session with HNC survivors to determine whether the intervention results in improved implementation of recommendations for HNC survivors. The investigators will aim to have 40% of survivorship recommendations implemented by 12 months post-intervention. Secondary study objectives will evaluate quality of life and satisfaction with care at 12 months post-intervention.

Detailed Description: This study is a longitudinal single arm trial. This intention to treat design supports the implementation of Treatment Summary and Survivorship Care Plans (TSSPs) to cancer survivors. The single arm trial will be administered through the survivorship clinic at a tertiary level cancer center in Ontario. 90 patients with curable stage I-IV head and neck mucosal cancer (HNC) will be recruited to the study. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Danielle MacNeil, MD, FRCSC

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

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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