ABSTRACT
PURPOSE: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL). METHODS: A pragmatic cluster preference randomised control trial with 15 consultants, 8 'using' and 7 'not using' the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible. RESULTS: Consultants saw a median (inter-quartile range) 16 (13-26) patients, with 140 PCI and 148 control patients. Of the pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (- 2.9%, 12.9%) but without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected decreased over time. CONCLUSION: This novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally.
Subject(s)
Head and Neck Neoplasms , Quality of Life , Emotions , Head and Neck Neoplasms/therapy , Humans , Referral and Consultation , Surveys and QuestionnairesABSTRACT
PURPOSE: The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described. METHODS: This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments). RESULTS: From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min). CONCLUSION: Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.
Subject(s)
Head and Neck Neoplasms , Quality of Life , Head and Neck Neoplasms/therapy , Humans , Neoplasm Staging , Referral and Consultation , Surveys and QuestionnairesABSTRACT
PURPOSE: Cancer patients can experience significant distress during their cancer trajectory, which impacts upon clinical outcomes and quality of life. Screening for distress using holistic assessments can help identify and address unmet concerns/needs. The purpose of this study was to evaluate the relationship between concerns and distress, and the impact of distress on clinic outcomes in post-treatment head and neck cancer patients. METHODS: 170 patients attending routine follow-up clinics were prospectively recruited. All patients completed the Patient Concerns Inventory (PCI) and the Distress thermometer (DT) at preconsultation. RESULTS: The rate of significant distress (i.e. DT cut-off score ≥4) was 36% (62/170). Significantly distressed patients selected more items overall than patients without distress (mean, median (QR) of 5.40, 5 (2-8) vs 2.61, 2 (0-4), p < 0.001). Significant distress was most strongly associated with Physical and Functional well-being (p < 0.001) and Psychological and Emotional well-being domains (p = 0.001). On balance, very little difference was noted between cut-off points of either ≥4 or ≥5 PCI items of concern selected. Both cut-off points demonstrated an acceptable level of sensitivity, specificity and predictive values for significant distress. Consultations were longer with increasing numbers of concerns. CONCLUSIONS: Just over one-third of patients are significantly distressed. They were more likely to express a higher number of concerns. A cutoff score ≥4 or ≥5 PCI items selected can identify those at risk of significant distress. Concerns causing significant distress were related to emotional/psychological issues and physical function.
Subject(s)
Head and Neck Neoplasms/psychology , Stress, Psychological/diagnosis , Aged , Diagnostic Self Evaluation , Female , Head and Neck Neoplasms/complications , Head and Neck Neoplasms/therapy , Humans , Male , Middle Aged , Prospective Studies , Stress, Psychological/etiology , Treatment OutcomeABSTRACT
The primary aim was to determine the efficacy of the Distress Thermometer (DT) in screening for anxiety and mood problems against the University of Washington Quality of Life, version 4 (UWQOL). Secondary aims were to evaluate the association between demographic, clinical and health-related QOL variables with significant distress. Two hundred and sixty one disease-free HNC ambulatory patients attending routine follow-up clinics were prospectively recruited. Both DT and UWQOL were completed pre-consultation. Receiver operating characteristic (ROC) curve analyses of DT score for anxiety dysfunction yielded an area under the curve (AUC) of 0.877, with a sensitivity of 84% (43/51) and specificity of 76% (159/210) for a DT cut-off of ≥4; with a corresponding AUC of 0.825 for mood with sensitivity 78% (28/36) and specificity 71% (159/225). Treatment with radiotherapy and a longer consultation time were associated with significant distress (DT ≥4). Significant distress was also reported in two third of those reporting less than "Good" overall QOL. Distress levels were particularly associated with poor Social-Emotional function, more so than the association seen with poor physical function. DT is a reasonable screening tool for distress in the HNC population. The DT cut-off score ≥4 was effective in identifying those with significant distress. Significant distress is associated in survivors with poor health-related quality of life, those who received radiotherapy and patients who have longer consultation times in clinic.