Recruiting

TSSP

Sponsor:

Western University, Canada

Code:

NCT06127784

Conditions

Head and Neck Cancer

Survivorship

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Motivational interviewing counselling session

Study Details

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 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.

Conditions

Head and Neck Cancer

Survivorship

Study ID

NCT06127784

Start date

May 1, 2025

Status verified date

Nov, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MI Counselling

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.

no intervention: Standard care

The standard care group will receive no intervention (no TSSP or MI counselling session).

Interventions

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

Primary outcome measure

  • Physician implementation of survivorship care recommendations [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Victoria Hospital, London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

More Information

Sponsor

Western University, Canada

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • Motivational Interviewing
  • Counselling
  • Survivorship Care Plan
  • Treatment Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2025-11-18.