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Survivorship After HNC: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 18, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 180 to 176
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2025 to May 1, 2025
    v5
  2. Notable Start date: Nov 1, 2024 to Feb 1, 2025v4
  3. Notable Enrollment target: 90 to 180v3 Show 5 more changesShow less
    • Start date: Jan 1, 2024 to Nov 1, 2024
    • Study completion date: Jul 1, 2026 to Jul 1, 2027
    • Study title expanded, about 7 words
    • Study arms: 1 to 2
    • Study description expanded, about 2 words
  4. Minor Interventions: Treatment summary and survivorship care plan and motivational interviewing counseling (Other) to Motivational interviewing counselling session (Other)
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study title shortened, about 4 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06127784
Lead Sponsor Western University, Canada
Conditions
(from sponsor)
Head and Neck Cancer, Survivorship
Related terms Head and Neck Neoplasms, Treatment Adherence and Compliance
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov