Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial

Abstract

BackgroundTotal laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application “In Tune without Cords” among patients treated with total laryngectomy.Methods/designPatients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application “In Tune without Cords”. Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.DiscussionThis randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.Trial registrationNTR5255 Protocol version 4 date September 2015.

Investigation of swallowing function and swallowing-related quality of life after partial laryngectomy in Chinese patients with laryngeal carcinoma

“…A previous study suggested that a patient support network may help solve swallowing problems using a patient-to-patient communication model [17]. Then, a clinical study was carried out to evaluate the effectiveness and cost-utility of a guided self-help exercise program among patients treated by total laryngectomy [29]. Long-term studies involving this patient population are also needed as it has been suggested that even the patients who successfully recover swallowing after function-preserving laryngeal surgery may lose this function later; indeed, patients present with aspiration 11–15 years after partial laryngectomy and require definitive total laryngectomy [30].…”

Costs from a healthcare and societal perspective among cancer patients after total laryngectomy: are they related to patient activation?

“…Further research should investigate whether patient activation can be improved in cancer patients, and whether this affects health status and total costs. A currently ongoing Dutch randomized controlled trial on the (cost-)effectiveness of a guided self-help program in TL cancer patients may provide further information regarding this association [ 10 ].…”

“…A previous systematic review of Panagioti et al [ 15 ] indeed found that self-management interventions for different populations with chronic illnesses may reduce healthcare utilization without compromising patients’ health outcomes. In cancer patients specifically, only few studies focused on the impact of self-management interventions on (healthcare) costs so far, although several researchers are planning to [ 8 – 10 ]. A recent study comparing psychologist-led care with a nurse-led self-management intervention in distressed cancer patients showed no evidence for cost-effectiveness of the self-management intervention [ 12 ].…”

The eHealth self-management application ‘Oncokompas’ that supports cancer survivors to improve health-related quality of life and reduce symptoms: which groups benefit most?

“…This suggests that improvement of HRQOL is possible for every cancer survivor, regardless of having a low or high HRQOL at the start of the intervention, and the benefit of Oncokompas might be through reducing symptom burden. Evidence on moderating effects of baseline values of HRQOL is inconsistent [5,42].…”