Assessment of cancer therapy-induced oral mucositis using a patient-reported oral mucositis experience questionnaire

Abstract

Objectives: Treatment of oral mucositis (OM) is challenging. In order to develop and test useful treatment approaches, the development of reliable, reproducible and simpler methods than are currently available for assessment of OM is important. A Patient-Reported Oral Mucositis Symptom (PROMS) scale was assessed in patients with head and neck cancer to determine if the patient-reported OM experience, as determined by using the PROMS scale, correlate with OM assessed by clinician-based scoring tools.

Materials and methods: Fifty patients with head and neck cancer and undergoing radiotherapy consented to participate. They were examined before cancer treatment and twice weekly during 6-7 weeks of therapy and once 4-6 weeks after therapy. Signs of OM were evaluated using the 3 clinician-based scoring tools; NCI-CTCAE v.3, the OMAS criteria and the Total VAS-OMAS. The participants' OM experiences were recorded using PROMS-questionnaires consisting of 10 questions on a visual analogue scale. Spearman rank correlation test were applied between the PROMS scale values and the clinician-determined scores. Repeated measures mixed linear models were applied to appraise the strengths of correlation at the different time points throughout the observation period.

Results: Thirty-three participants completed all stages of the study. The participant experience of OM using the PROMS scale demonstrates good correlations (Spearman's Rho 0.65-0.78, p<0.001) with the clinician-determined scores on the group level over all time points and poor to good correlations (Spearman's Rho -0.12-0.70, p<0.001) on the group level at different time points during and after therapy. When mouth opening was problematic, i.e. during the 6th and 7th week after commencing cancer treatment, the Spearman's Rho varied between 0.19 and 0.70 (p<0.001).

Conclusion: Patient experience of OM, as reported by the PROMS scale may be a feasible substitute for clinical assessment in situations where patients cannot endure oral examinations.

Figure 1. Oral mucositis is a side-effect of radiation treatment that leads to pain and limitations of mouth opening and numerous oral functions.

Figure 2. PROMS scale questionnaire with the ten components each detailing two extremes of a functional characteristic within a 100(VAS) (23).

Figure 3. NCI-CTCAE v.3 (Cumulative %) (No color = Score 0, Dark = Score 3) recorded over the cancer treatment period (7 weeks) and at the 4–6 week post-therapy examination.

Figure 4. Clinical signs and patient symptoms recorded over the observation period (7 weeks) and at the 4–6 week post-therapy examination (“P”).

From top to bottom: OMAS Scores for Ulceration (Means +/− SDs; maximum score = 27), OMAS Scores for Erythema (Means +/− SDs; maximum score = 18), TOTAL-VAS-OMAS Score for Ulceration (Means +/− SDs), TOTAL-VAS-OMAS Score for Erythema (Means +/− SDs) and PROMS scale value (Means +/− SDs). (All VAS scales: maximum value = 100).

Figure 5. Spearman rho correlation coefficients over the observation period (7 weeks) and at the 4–6 week post-therapy examination between clinical signs of oral mucositis, as reported by different clinician-based scoring tools and the experience of oral mucositis by the participants, as reported by the PROMS scale.

PROMS scale value vs. scores for: NCI-CTCAE v.3 (a), OMAS-Ulceration (b), OMAS Erythema (c), TOTAL-VAS-OMAS Ulceration (d) and TOTAL-VAS-OMAS Erythema (e).