Survivorship After HNC: Evaluating Adherence to Follow-up

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127784
• Other study ID #: 123657
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: November 2023
• Source: Western University, Canada
• Contact: Agnieszka Dzioba, PhD
• Phone: 519-685-8500
• Email: Agnieszka.Dzioba[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Survivorship

Intervention

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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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