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Introduction. This study aimed to investigate the effectiveness of a guided self-help Head and Neck exercise program on swallowing, speech, and shoulder problems in patients treated with total laryngectomy (TL).Methods. This randomized controlled trial included patients treated with TL in the last 5 years. Patients randomized into the intervention group received a self-help exercise program and a self-care education program, whilst the control group received a self-care education program only. Both groups completed patient-reported outcome measures before randomization, at 3 and at 6 months follow-up. The primary outcome was swallowing problems (SWALQOL). Secondary outcomes were speech problems (SHI), shoulder problems (SDQ), patient activation (PAM) and health-related quality of life (HRQOL: EORTC QLQ-C30/H&N35). Adherence was defined as moderate to high in case the patient exercised >1 per day. Linear mixed model analyses were conducted to investigate the effectiveness of the intervention group compared to the control group and to investigate whether severity of problems and neck dissection surgery moderated the effectiveness.Results. Adherence to the exercise program was moderate-high (59%). Patients randomized to the intervention group (n=46) reported less swallowing problems over time compared to the control group (n=46) (p-value two-way interaction=0.013). Also, less communication problems were reported over time (p-value two-way interaction=0.004). No difference was found in speech, shoulder problems, patient activation and HRQOL. Severity of problems and neck dissection surgery did not moderate the effectiveness of the exercise program.Conclusions. The guided self-help exercise program improves swallowing and communication in TL patients.

Introduction. Stepped care (SC), consisting of watchful waiting, guided self-help, problem-solving therapy and psychotherapy/medication is, compared to care-as-usual (CAU), effective in improving psychological distress. This study presents secondary analyses on subgroups of patients who might specifically benefit from watchful waiting, guided self-help, or the entire SC program. Methods. In this randomized controlled trial, head and neck and lung cancer patients with distress (n=156) were randomized to SC or CAU. Univariate logistic regression analyses were performed to investigate baseline factors associated with recovery after watchful waiting and guided self-help. Potential moderators of the effectiveness of SC compared to CAU were investigated using linear mixed models. Results. Patients without a psychiatric disorder, with better psychological outcomes (HADS: all scales) and better health-related quality of life (HRQOL) (EORTC QLQ-C30/H&N35: global QOL, all functioning and several symptom domains) were more likely to recover after watchful waiting. Patients with better scores on distress, emotional functioning, and dyspnea were more likely to recover after guided self-help. Sex, time since treatment, anxiety or depressive disorder diagnosis, symptoms of anxiety, symptoms of depression, speech problems and feeling ill at baseline moderated the efficacy of SC compared to CAU. Conclusions. Patients with distress but who are relatively doing well otherwise, benefit most from watchful waiting and guided self-help. The entire SC program is more effective in women, patients in the first year after treatment, patients with a higher level of distress or anxiety or depressive disorder, patients who are feeling ill, and patients with less speech problems.