Head and Neck CancerNCT06127784
Survivorship After HNC: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
A study testing Motivational interviewing counselling session in people with Head and Neck Cancer and Survivorship, run by Western University, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Survivorship
- What is being tested?
- Motivational interviewing counselling session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Second concurrent non-cutaneous malignancy
- Metastatic disease
- Clinically apparent cognitive impairment
- Suspected residual disease after treatment completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Victoria Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Julie Strychowsky, 5196704100, Julie.Strychowsky@lhsc.on.ca
About this study
Official title: Survivorship After Head and Neck Cancer: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
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.
Read the detailed description
This study is a longitudinal randomized controlled trial. Patients will be randomly assigned to either usual treatment or the intervention (MI counselling session). Data will be collected at four time points: baseline (3-6 months post-treatment for HNC), and 3-, 6- and 12- months post-baseline visit. 180 patients with curable stage I-IV head and neck mucosal cancer (HNC) will be recruited to the study (90 per arm).
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.
- Conditions
- Head and Neck Cancer, Survivorship
- Being tested
- Motivational interviewing counselling session
- Keywords
- Motivational Interviewing, Counselling, Survivorship Care Plan, Treatment Adherence
- Medical subject headings
- Head and Neck Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing counselling sessionOther
Also called MI
Individually tailored treatment summary and survivorship care plan provided within a 1-hour 1 hour counseling session with a clinical nurse specialist
| Study group | Role | What they receive |
|---|---|---|
| MI Counselling | Experimental | 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. Receives: Other: Motivational interviewing counselling session |
| Standard care | No intervention | The standard care group will receive no intervention (no TSSP or MI counselling session). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 and compared between the intervention and standard care group.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 May 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized controlled trial at a single centre with 2 groups of 88 adults. The intervention 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. The standard care group will receive standard of care treatment.
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle MacNeil, Western University, Canada
- Investigators
- Danielle MacNeil, MD, FRCSC, Principal investigator, Department of Otolaryngology-Head & Neck Surgery, Western University Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127784
- Sponsor's protocol ID
- 123657
- Status last verified
- Nov 2025
- First submitted
- 6 Nov 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available upon request
Publications
Tran B, Dzioba A, Baker J, Mutsaers A, Nichols AC, Mendez A, Goodman CD, Palma DA, Winquist E, Irwin JD, Fung K, Stewart P, Lang P, Correa RJM, Kuruvilla S, Mitchell S, Phillips T, MacNeil SD. The SHARE study - Survivorship After Head and Neck Cancer: evaluating patient care and adherence to follow up in Ontario, Canada: study protocol for a randomized controlled trial. Trials. 2025 Dec 13;27(1):48. doi: 10.1186/s13063-025-09332-5.
PubMed 41390453
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship After Head and Neck Cancer: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
- ClinicalTrials.gov ID
- NCT06127784
- Acronym / sponsor ID
- 123657
- Conditions
- Head and Neck Cancer, Survivorship
- Keywords
- Motivational Interviewing, Counselling, Survivorship Care Plan, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a longitudinal randomized controlled trial. Patients will be randomly assigned to either usual treatment or the intervention (MI counselling session). Data will be collected at four time points: baseline (3-6 months post-treatment for HNC), and 3-, 6- and 12- months post-baseline visit. 180 patients with curable stage I-IV head and neck mucosal cancer (HNC) will be recruited to the study (90 per arm).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized controlled trial at a single centre with 2 groups of 88 adults. The intervention 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. The standard care group will receive standard of care treatment.
| Arm | Type | Receives |
|---|---|---|
| MI Counselling | Experimental | Other: Motivational interviewing counselling sessionAn 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. |
| Standard care | No intervention | –The standard care group will receive no intervention (no TSSP or MI counselling session). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Second concurrent non-cutaneous malignancy
- Metastatic disease
- Clinically apparent cognitive impairment
- Suspected residual disease after treatment completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing counselling sessionAlso: MIIndividually tailored treatment summary and survivorship care plan provided within a 1-hour 1 hour counseling session with a clinical nurse specialist | Other | MI Counselling |
Primary outcome
Physician implementation of survivorship care recommendations
Time frame: 12 months
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 and compared between the intervention and standard care group.
4 secondary outcomes
Satisfaction with Care and Information Scale
Time frame: Baseline, 3, 6, and 12 months post-intervention
M.D. Anderson Symptom Inventory, Head and Neck Module (MDASI-HN)
Time frame: Baseline, 3, 6, and 12 months post-intervention
Patient Satisfaction with TSSP and Counselling SessionB
Time frame: Baseline
Physician Satisfaction with TSSP
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 41390453Tran B, Dzioba A, Baker J, Mutsaers A, Nichols AC, Mendez A, Goodman CD, Palma DA, Winquist E, Irwin JD, Fung K, Stewart P, Lang P, Correa RJM, Kuruvilla S, Mitchell S, Phillips T, MacNeil SD. The SHARE study - Survivorship After Head and Neck Cancer: evaluating patient care and adherence to follow up in Ontario, Canada: study protocol for a randomized controlled trial. Trials. 2025 Dec 13;27(1):48. doi: 10.1186/s13063-025-09332-5.
- Individual participant dataSharing planned: No. Data will be made available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle MacNeil, MD, FRCSC principal investigator
Department of Otolaryngology-Head & Neck Surgery, Western University Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing counselling session in people with Head and Neck Cancer and Survivorship, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Dzioba, PhD (519-685-8500, Agnieszka.Dzioba@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician implementation of survivorship care recommendations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.