NCT06127784Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 6 Nov 2023
- Start date
- 1 May 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Western University, Canada
- Diseases
- Head and neck cancer
- NCT number
- NCT06127784
What you commit to
- Study type: Interventional
- Planned participants: 176
- From 1 May 2025 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Second concurrent non-cutaneous malignancy
Other illness
- Metastatic disease
- Clinically apparent cognitive impairment
- Suspected residual disease after treatment completion
Who the study is looking for
- 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
Criteria the registry did not label
- Patient Participants
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Victoria Hospital, London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.