Survivorship After HNC: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Second concurrent non-cutaneous malignancy
Metastatic disease
Clinically apparent cognitive impairment
Suspected residual disease after treatment completion
Trial design
Design model
Parallel
Treatments tested in this trial
Motivational interviewing counselling session
Other interventionIndividually tailored treatment summary and survivorship care plan provided within a 1-hour 1 hour counseling session with a clinical nurse specialist
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: MI CounsellingExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
Baseline, 3, 6, and 12 months post-intervention2
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).
Time frame
Baseline, 3, 6, and 12 months post-intervention3
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
Time frame
Baseline4
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov