Acceptability was measured by the proportion of patients approached and consented and the number of sessions attended. Retention rates and reasons for drop out was documented. We aimed for a 50% recruitment rate for CB-EST to be deemed an acceptable treatment.
Feasibility and fidelity were measured by assessing whether the intervention could be delivered as planned, by a SLT with CBT training. Session content and treatment plans, recorded in patients’ notes were evaluated by a CBT expert practitioner as part of supervision, reliability and validity checking. Content analysis of sessions including a) whether a therapy goal was identified b) whether a CBT formulation was identified c) whether cognitive and/or behaviour change techniques were used. These outcomes would also indicate the acceptability of the intervention to patients.
A selection of candidate measures targeting swallowing self-report, dietary restrictions, quality of life, functioning and mood were chosen to identify appropriate tools to capture CB-EST outcomes. Acceptability to patients was monitored by percentage data completion. The measures listed below and were administered pre-, immediately following CB-EST, and at three months.
The MDADI [13 ] has twenty items, each marked using a five-point scale and summarised using a total score (range 20–100). Higher scores indicate a better outcome and a change in ≥10 points is considered a clinically significant difference [15 ].
The European Organization for Research and Treatment of Cancer questionnaires (EORTC QLQ-C30) [16 (link)] is a general quality of life questionnaire with 30 items, five functioning scales (physical, role, emotional, cognitive, and social), three symptom scales. The EORTC QLQ-H&N35 is a disease-specific module of 35 questions divided into 7 subscales about pain, swallowing, senses, speech, social eating, social contact, and sexuality. Higher scores on the functional scales refer to better health status, whereas higher scores in symptom scales and the QLQ-H&N35 represent more severe symptoms.
Chalder Fatigue Questionnaire (CFQ-11) [17 (link)] measures fatigue severity. Eleven items are answered on a four-point scale (range 0–33), with high scores representing more fatigue.
Work and Social Adjustment Scale(WASA) [18 (link)] measures functional and social impairment. Five questions are answered on a nine-point scale (range 0–40) with higher scores indicating more impairment.
Hospital Anxiety and Depression Scale (HADS) [19 (link)] has two seven item subscales measuring anxiety (HADS-A) and depression (HADS-D). Each item is scored on a four-point scale (range 0–21 for each subscale). Subscale scores 0–7 classify participants as non-cases, 8–10 indicates borderline cases, and scores ≥11 indicate clinical levels. Total HADS scores (HADS-T) ≥ 15 indicate clinically significant distress.
Performance Status Scales (PSS) Normalcy of Diet [20 (link)] measures diet texture restrictions and is clinician-rated. The scale has ten ranked categories ranging from 0 (nil by mouth) to 100 (full diet without restrictions).
The acceptability and feasibility of delivering CB-EST as-was or modifying it for a larger trial was further assessed using semi-structured interviews. Patients were purposively sampled to ensure a range of pre to post CB-EST changes in MDADI scores, a range of HNSCC treatment and time post-treatment. Patients were selected from those at the initial stages of CB-EST and at the end of CB-EST. Interviews were conducted by two independent researchers. Patients had the option of a telephone or face to face interview, at a time and place of their choice. All interviews were digitally recorded, transcribed verbatim and anonymised. Transcripts were read several times and in detail by the qualitative sub-team. Data were then discussed and coded using thematic analysis. Quotations relating to afore mentioned topics were independently selected and coded into key issues and themes.
