Clinical trial NCT06127784: Survivorship After HNC: a Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
Official title: Survivorship After Head and Neck Cancer: a Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Survivorship
Keywords: Motivational Interviewing
Counselling
Survivorship Care Plan
Treatment Adherence
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized controlled trial at a single centre with 2 groups of 90 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician implementation of survivorship care recommendations
timeFrame: 12 months
Secondary outcomes:
measure: Satisfaction with Care and Information Scale
timeFrame: Baseline, 3, 6, and 12 months post-intervention
measure: M.D. Anderson Symptom Inventory, Head and Neck Module (MDASI-HN)
timeFrame: Baseline, 3, 6, and 12 months post-intervention
measure: Patient Satisfaction with TSSP and Counselling SessionB
timeFrame: Baseline
measure: Physician Satisfaction with TSSP
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Department of Otolaryngology-Head & Neck Surgery, Western University Canada
name: Danielle MacNeil, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: