Survivorship After HNC: Evaluating Adherence to Follow-up

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Survivorship, Head and Neck Cancer

Intervention / Treatment
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* Other: Motivational interviewing counselling session


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, single arm longitudinal trial at a single centre with 1 group of 90 adults. The study group will receive a one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients delivered within a motivational interviewing counselling session with a clinical nurse specialist.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI Counselling<br>An individualized treatment summary and survivorship care plan (TSSP) will be prepared within a one-hour motivational interviewing (MI) counseling session with a clinical nurse specialist. Participants will be asked to identify their top three symptom/survivorship concerns. The intervention will address symptoms/survivorship care specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists. Patient participants will engage in role play to empower them to follow-up with their healthcare provider regarding their survivorship care needs. | Other: Motivational interviewing counselling session<br>* Individually tailored treatment summary and survivorship care plan provided within a 1-hour 1 hour counseling session with a clinical nurse specialist<br>* Other names: MI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician implementation of survivorship care recommendations | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Care and Information Scale | 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. | Baseline, 3, 6, and 12 months post-intervention | 
| M.D. Anderson Symptom Inventory, Head and Neck Module (MDASI-HN) | 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). | Baseline, 3, 6, and 12 months post-intervention | 
| Patient Satisfaction with TSSP and Counselling SessionB | Investigator developed survey evaluating patient satisfaction with and feedback on the utility of the TSSP and motivational interviewing counseling session | Baseline | 
| Physician Satisfaction with TSSP | 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational Interviewing, Counselling, Survivorship Care Plan, Treatment Adherence