Integration of a smoking cessation program in the treatment protocol for patients with head and neck and lung cancer.

Smoking is the main causative factor for development of head and neck and lung cancer. In addition, other malignancies such as bladder, stomach, colorectal, kidney and pancreatic cancer have a causative relation with smoking. Continued smoking after having been diagnosed with cancer has many negative consequences: effectiveness of radiotherapy is diminished, survival time is shortened and risks of recurrence, second primary malignancies and treatment complications are increased. In view of the significant health consequences of continued smoking, therefore, additional support for patients to stop smoking seems a logical extension of the present treatment protocols for smoking-related cancers. For prospectively examining the effect of nursing-delivered smoking cessation programme for patients with head and neck or lung cancer, 145 patients with head and neck or lung cancer enrolled into this programme over a 2-year period. Information on smoking behaviour, using a structured, programme specific questionnaire, was collected at baseline, and after 6 and 12 months. At 6 months, 58 patients (40%) had stopped smoking and at 12 months, 48 patients (33%) still had refrained from smoking. There were no differences in smoking cessation results between patients with head and neck and lung cancer. The only significant factor predicting success was whether the patient had made earlier attempts to quit smoking. A nurse-managed smoking cessation programme for patients with head and neck or lung cancer shows favourable long-term success rates. It seems logical, therefore, to integrate such a programme in treatment protocols for smoking-related cancers.

The psychological impact of annual chest X-ray follow-up in head and neck cancer.

CONCLUSION: Annual post-treatment screening of head and neck squamous cell carcinoma (HNSCC) patients for second primary lung cancer and metastatic recurrence appeared to form no major burden for head and neck cancer patients. A majority of patients regard the annual chest X-ray as a reassurance. Given these results a more intensive screening program seems psychologically justifiable for this group. OBJECTIVE: To assess the psychological impact of annual post-treatment screening for second primary lung cancer and metastases in HNSCC patients. PATIENTS AND METHODS: In a cohort of 106 patients, 68 men and 38 women, with a mean age of 56, the impact of the yearly chest radiograph was evaluated by means of a nine-item questionnaire. RESULTS: In all, 90% of the patients were in favor of annual post-treatment screening, 2% would not like to receive this screening, and 8% had no preference. A majority (98%) considered the screening as an extra medical check and 76% felt reassured. Although 21% of the patients were very nervous about the outcome of the screening, only 3% wanted to avoid the yearly chest X-ray for this reason.

Compliance, quality of life and quantitative voice quality aspects of hands-free speech.

CONCLUSIONS: With the use of a new automatic stoma valve (ASV) it appears possible to rehabilitate patients who have previously been unsuccessful in acquiring hands-free speech. As well as making daily ASV use possible for an additional group of patients, this new device was also appreciated by many patients as an additional rehabilitation tool for specific occasions. Despite statistically significant improvements in aspects of voice and breathing using this novel ASV, improvement of peristomal adhesion is probably the main factor needed to further increase success rates. Nevertheless, our results show that it makes sense to keep trying to achieve hands-free speech, even if previous attempts have failed. OBJECTIVE: To make a long-term (6 months) assessment of compliance and aspects of voice, breathing and quality of life using a new ASV: the Provox FreeHands heat and moisture exchanger (HME). MATERIAL AND METHODS: This was a prospective clinical multicentre trial in 79 laryngectomized patients (8 regular ASV users, 58 previously unsuccessful users and 13 new users). Data were collected at baseline and after 1 and 6 months by means of European Organization for Research and Treatment of Cancer Quality of Life questionnaires and specific structured questionnaires concerning compliance, skin adhesion, voicing and pulmonary aspects. An objective assessment of voice parameters (maximum phonation time, maximum phonation time while counting, dynamic loudness range and number of pauses in a standard read-aloud text) was made for comparison of different stoma occlusion methods (digital occlusion via an HME and two different ASVs). A subjective assessment of overall voice quality was made. RESULTS: After 6 months, 19% of patients used the new ASV on a daily basis (mean 5 h/day), while 57% used it on an irregular basis as an additional rehabilitation tool for special occasions. Two-thirds of the study group indicated that they would continue to use the new ASV after the study period. With respect to the objective parameters, statistically significantly better maximum phonation times and dynamic loudness ranges were observed with the new ASV compared to the Blom-Singer ASV. However, the best results for all the objective parameters were obtained with digital occlusion via the Provox HME.

Long-term compliance of laryngectomized patients with a specialized pulmonary rehabilitation device: Provox Stomafilter.

Previous studies have demonstrated the positive effect of a heat and moisture exchanger (HME) on the respiratory system in patients after laryngectomy. However, patient compliance with these devices was reduced by device-related problems and troublesome combination with a voice prosthesis. Recently a more specialized device has become available. This is an HME combined with a valve for easy digital occlusion of the stoma (Provox Stomafilter; Hörby, Sweden). In the authors' initial study of this revised device, a clear improvement in short-term compliance was demonstrated. To investigate long-term compliance, 69 consecutive patients were interviewed by means of a structured questionnaire. The results show that all patients expressed their satisfaction with the valve used for digital occlusion of the stoma. Sixty-three percent of the patients reported that voicing was facilitated. Subjective intelligibility improved in 55% of the patients. Previous problems with other devices (e.g., plaster adherence, skin irritation, and handling) were clearly diminished, increasing the long-term compliance of the patients to 78%. This new HME can be considered as a beneficial pulmonary rehabilitation tool for laryngectomized patients.

Multi-institutional assessment of the Provox 2 voice prosthesis.

OBJECTIVES: To verify the initial results of a new anterograde replacement method of the second-generation indwelling Provox voice prosthesis, Provox 2 (Atos Medical AB, Hörby, Sweden), and to determine its device life. DESIGN: Nonrandomized, multi-institutional, controlled clinical trial. SETTING: Four academic hospitals and/or comprehensive cancer centers in The Netherlands. PATIENTS: Two hundred thirty-nine consecutive patients who had undergone laryngectomy and were visiting the outpatient clinic for replacement of their voice prosthesis. INTERVENTION: Anterograde replacement of the Provox 2 voice prosthesis. MAIN OUTCOME MEASURES: Evaluation of ease of use by the medical professional and appreciation by the patients, by means of structured questionnaires; comparison of device life between the original Provox and the new Provox 2 voice prosthesis in a subset of patients. RESULTS: Voice prostheses replaced were Provox (n = 188), Groningen (Medin, Groningen, The Netherlands) (n = 47), and Nijdam (Medin) (n = 4). Anterograde replacement of Provox 2 was always possible. The new anterograde method was preferred by the medical professionals in 97.1% of cases and by 93.7% of the patients, who reported significantly reduced discomfort (P<.001). There was no significant difference in device life between Provox and Provox 2 (median, 125.5 and 104 days, respectively). In 57.5% of patients, the Provox 2 device life was shorter and in 42.5% it was longer (sign test, P = .09). CONCLUSIONS: The results of the initial study concerning ease of use for the medical professionals and decreased discomfort for the patients of the new anterograde replacement procedure of the Provox 2 prosthesis were confirmed. The device life of Provox and that of Provox 2 were comparable, despite the alterations needed to optimize the Provox 2 prosthesis for the anterograde procedure.

Improvements in respiratory and psychosocial functioning following total laryngectomy by the use of a heat and moisture exchanger.

A prospective clinical study in 61 patients was undertaken to investigate the subjective and objective influence of a heat and moisture exchanger (HME) on the respiratory and psychosocial problems following total laryngectomy. Although statistical comparisons failed to detect significant differences between the experimental and the control groups, there was a clear trend toward improvements in respiratory and psychosocial functioning in the experimental group. Analyses of differences over time within the HME user group showed significant reductions in the incidence of coughing, the mean daily frequency of sputum production, forced expectoration, and stoma cleaning. Significant improvements were also found in shortness of breath, fatigue and malaise, sleep problems, levels of anxiety and depression, and perceived voice quality. Pulmonary function tests showed significant improvements in inspiratory flow and volume values following use of the HME. This objective improvement in inspiratory pulmonary function reflects the decrease in sputum production reported by the patients.

The influence of stoma occlusion on aspects of tracheoesophageal voice.

In this study, speech of 21 laryngectomized patients is investigated under 2 different stoma occlusion conditions, i.e. direct digital occlusion of the stoma (by thumb or finger), and digital occlusion (by finger) via a special heat and moisture exchanger with speech valve (Provox Stomafilter). For both conditions, acoustical analyses of voice quality (various pitch, amplitude, tremor and harmonicity measures) were performed on a sustained /a/, the mean maximum phonation time was calculated, and a phonetogram was made. Acoustical analysis was possible in 13 of the 21 voices (for the other voices, the pitch was too low or the voice was too aperiodic), but no statistical significant differences were found for any of the acoustical parameters studied. However, the maximum phonation time was significantly longer, and the dynamic range significantly larger, under the Stomafilter occlusion condition. The maximum phonation time showed a relevant improvement in 57% of the patients, while the dynamic range showed a relevant improvement in 35% of the patients. In total, 75% of the patients experience an improvement in one or both of these speech characteristics when using the Stomafilter occlusion. It can be concluded that optimal stoma occlusion by means of a specialized device has a positive influence on two relevant parameters of prosthetic voice production: maximum phonation time and dynamic loudness range.

Development and clinical evaluation of a second-generation voice prosthesis (Provox 2), designed for anterograde and retrograde insertion.

Prosthetic voice restoration has considerably improved the results of vocal rehabilitation after total laryngectomy, and is presently the method of choice for many health-care providers treating laryngectomized patients. The Provox voice prosthesis, developed in the Netherlands Cancer Institute, is an indwelling device that has been applied in recent years with regular success. Its retrograde replacement method, using a disposable guide wire, assures reliable, atraumatic positioning of the prosthesis in the tracheoesophageal fistula. However, the method sometimes may be uncomfortable for the patient; therefore an adapted prosthesis and new replacement equipment were developed, which enable bidirectional insertion, i.e. not only in the traditional retrograde manner through the pharynx, but especially in an anterograde manner through the stoma. This second-generation voice prosthesis (Provox 2) was studied in a prospective clinical trial in 44 patients (33 experienced patients, seven first-time replacements and four primary insertions). The study demonstrated that the anterograde insertion with the Provox 2 system was applicable in all patients, making the voice prosthesis even easier to handle than with the traditional retrograde method. A stenosis of the pharyngoesophageal segment no longer interfered with the replacement. In addition, the patients judged the new method as being favourable, reporting significantly less discomfort during the replacement procedure (paired Student's t-test: p < 0.0001). Furthermore, the adapted voice prosthesis could be removed from the tracheoesophageal fistula without excessive force (mean 7.9 N, range 6.0-14.0 N), more easily than the original Provox (mean 20.9 N, range 5.5-25.0 N). It can be concluded that this second-generation indwelling voice prosthesis (Provox 2) seems to be a further improvement in the application of this voice rehabilitation system, not only simplifying the replacement procedure, but also diminishing the discomfort for the patient.

[Physical and psychosocial sequelae of total larynx extirpation and the use of a heat and moisture exchanger]. / Lichamelijke en psychosociale gevolgen van totale larynxextirpatie en het gebruik van een warmte- en vochtwisselaar.

The incidence and severity of respiratory symptoms after total laryngectomy and their influence on everyday life were studied in 59 patients. Almost all patients (98%) have daily complaints of excessive sputum production and 64% of coughing. More than half the patients (57%) use forced expectoration more than 5 times a day in order to clear the airways and 37% have to clean the stoma more than 5 times a day. Respiratory problems appear to impair the quality of the voice, social contacts and psychological wellbeing and are associated with increased fatigue and sleep problems. In a prospective study the effect of a heat and moisture exchanger (HME) was measured in 42 patients. The frequency of sputum production, forced expectoration to clear the airways and stoma cleaning diminished significantly. As a result, feelings of fatigue decreased and social contacts improved. Respiratory problems after total laryngectomy deserve more attention. Treatment with an HME can in selected cases improve several other physical and psychosocial problems associated with this operation.

Parotid gland sparing IMRT for head and neck cancer improves xerostomia related quality of life.

BACKGROUND AND PURPOSE: To assess the impact of intensity modulated radiotherapy (IMRT) versus conventional radiation on late xerostomia and Quality of Life aspects in head and neck cancer patients. PATIENTS AND NETHODS: Questionnaires on xerostomia in rest and during meals were sent to all patients treated between January 1999 and December 2003 with a T1-4, N0-2 M0 head and neck cancer, with parotid gland sparing IMRT or conventional bilateral neck irradiation to a dose of at least 60 Gy, who were progression free and had no disseminated disease (n = 192). Overall response was 85% (n = 163); 97% in the IMRT group (n = 75) and 77% in the control group (n = 88) the median follow-up was 2.6 years. The prevalence of complaints was compared between the two groups, correcting for all relevant factors at multivariate ordinal regression analysis. RESULTS: Patients treated with IMRT reported significantly less difficulty transporting and swallowing their food and needed less water for a dry mouth during day, night and meals. They also experienced fewer problems with speech and eating in public. Laryngeal cancer patients in general had fewer complaints than oropharynx cancer patients but both groups benefited from IMRT. Within the IMRT group the xerostomia scores were better for those patients with a mean parotid dose to the "spared" parotid below 26 Gy. CONCLUSION: Parotid gland sparing IMRT for head and neck cancer patients improves xerostomia related quality of life compared to conventional radiation both in rest and during meals. Laryngeal cancer patients had fewer complaints but benefited equally compared to oropharyngeal cancer patients from IMRT.

Hands-free speech after surgical voice rehabilitation with a Provox voice prosthesis: experience with the Provox FreeHands HME tracheostoma valve system.

Excellent results have been reported with the use of voice prostheses for the rehabilitation of laryngectomees. Patients, however, consider it a disadvantage that the tracheostoma must be closed manually for speech production. This limits their ability to simultaneously communicate by gesture or to work with both hands. An automatic tracheostoma valve helps patients overcome this problem. We describe a prospective clinical trial evaluating our experience with the Provox FreeHands HME Automatic Tracheostoma Valve system. Twenty-four laryngectomees were randomly selected from the patients who had undergone laryngectomy at the ENT Department. Immediately, after 4 weeks and 6 months later having been fitted with a Provox FreeHands HME, the patients were asked to complete a questionnaire in order to assess their satisfaction, voice quality, wearing comfort, fixation, potential problems, and the effectiveness of the HME cassette. In addition, we investigated relevant voice quality parameters including dynamics range, frequency range of the speaking voice, and maximum phonation time. Seven patients discontinued the study due to problems of securing the valve to the skin (four patients) or recurrent cancer (three patients). Ten of the remaining 17 patients wore the valve daily for an average of 8.4 h. A total of 88% of the patients considered it a great advantage to be able to speak without having to use their hands. With the Provox FreeHands HME, maximum phonation time was 8.7 (+/-6.2) s and the dynamic range was 21.9 (+/-5.8) decibels. The results show that the Provox FreeHands HME Automatic Tracheostoma Valve system not only allows hands-free speech but is also associated with excellent compliance and good voice rehabilitation.

Quality of life assessment in laryngectomized individuals: do we need additions to standard questionnaires in specific clinical research projects?

OBJECTIVES: To assess, whether the EORTC questionnaires QLQ-C30 and QLQ-H&N35 give enough detailed information to study specific quality of life (QoL) related issues in laryngectomized individuals. DESIGN: Multicentre, prospective clinical trial; baseline measurement with EORTC questionnaires and an additional questionnaire, focusing on specific postlaryngectomy problems. SETTING: Head and Neck Department of one Comprehensive Cancer Center and three Academic Medical Hospitals in the Netherlands. PARTICIPANTS: Eighty laryngectomized individuals, selected to participate in a prospective clinical trial on hands-free tracheoesophageal speech. MAIN OUTCOMES MEASURES: Comparison of QoL dimensions, as assessed with the standard EORTC questionnaires, with the information obtained with additional questions, aimed at discovering in more detail, e.g. voice and respiratory problems in laryngectomized individuals. RESULTS: Based on the EORTC QoL questionnaires a good overall and voice specific QoL-level was found. However, the additional questionnaire showed that especially concerning voice and respiration more specific information was obtained. For example, despite an overall satisfaction with many aspects of the voice in more than three-quarters of the patients, speaking in a noisy environment was reported by 63% of the patients as being a serious problem, and a significant relation could be established between pulmonary and voicing problems (r = 0.28, P < 0.05), something also undetectable with the EORTC questionnaires. CONCLUSIONS: These findings underline the necessity to develop and use more specific additional questionnaires as an adjunct to the existing EORTC questionnaires, when studying specific symptoms in laryngectomized individuals, especially in order to detect intervention related changes over time.

Comprehensive rehabilitation after total laryngectomy is more than voice alone.

Comprehensive rehabilitation after total laryngectomy is more than voice alone. The removal of the larynx and the subsequent disconnection of the upper and lower airways not only has consequences for the vocal function but also for the respiratory system, and for the olfactory acuity of the patient. The results of the research program on these three subjects in the Netherlands Cancer Institute over the last 12 years are discussed in detail along with some of the relevant other literature on the topics. The considerable progress in these areas over the last 2 decades has clearly improved the quality of life of laryngectomized patients.

A new heat and moisture exchanger with speech valve (Provox stomafilter).

In previous studies investigating the influence of a heat and moisture exchanger on the respiratory and psychosocial problems of laryngectomized patients, the value of regular use of such a device could clearly be established. However, the compliance with the use of these devices was not optimal, mainly due to problems related to the plaster and to the often troublesome combination of these HMEs with a voice prosthesis. Therefore, a prospective, clinical trial was undertaken to investigate whether the use of a newly developed heat and moisture exchanger (HME, Provox stomafilter) could improve the acceptibility of such a device. In total, 19 patients participated in this study, 13 men and six women. Vocal rehabilitation was achieved with a Provox voice prosthesis in all patients. Each of the patients was provided with a supply of HMEs for a 3-week trial period. The results showed that all patients were clearly positive about the valve used for digital occlusion of the stoma. Voicing was considerably facilitated and the intelligibility improved. Problems experienced in previous studies related to the adhesive tape, such as skin irritation, inadequate adherence and loosening of the plaster by coughing or forced expectoration, could be solved by the availability of the different adhesives included in this system.

Communication, functional disorders and lifestyle changes after total laryngectomy.

Functional changes after total laryngectomy, including voice quality, hyposmia and dysgeusia, nasal discharge, swallowing and smoking habits were studied by means of a structured interview with 63 laryngectomized patients. Eighty per cent of the patients reported that they were satisfied with the quality of their voice including speaking on the telephone. Significant correlations were found between the quality of the voice and fatigue, frequency of making telephone calls and anxiety about speaking (P < 0.01). Vocal rehabilitation was achieved in the majority of patients (78%) with the indwelling Provox voice prosthesis. Forty-five per cent of the patients complained about annoying eructation. Hyposmia was reported by 52% of the patients, while 15% experienced dysgeusia. A significant correlation was found between hyposmia and dysgeusia (R = 0.43, P < 0.001). All patients with a taste problem also reported a poor sense of smell. Daily nasal discharge was reported by 38% of the patients. Due to difficulties in swallowing solid food, about one quarter of the patients changed their diet. All but one patient had been heavy smokers pre-operatively. Only 9% continued to smoke post-operatively. These results, along with the previously reported respiratory problems resulting from total laryngectomy, should be taken into account in counselling patients who are candidates for this surgical procedure.

Long-term pulmonary function after total laryngectomy.

In 58 laryngectomized patients pulmonary function tests were performed during a routine visit to the outpatient clinic. The assessment of pulmonary function with an extratracheal device could easily and reliably be accomplished in all instances. The results show that in long-term follow-up post-laryngectomy expiratory lung function values are significantly lower than predicted. Of the various subjective respiratory complaints, only a higher frequency of coughing was statistically significantly associated with decreased lung function values (P < 0.01). Neither time since surgery (> 1 year vs < 1 year), nor radiation therapy seemed to be correlated with the pulmonary function outcomes. In contrast, the age of the patient did have a significant influence. Although an age-related decline in pulmonary function is a well documented phenomenon, an additional adverse effect was suggested by the present series in the group who was over 65 years of age. Bronchodilator treatment was found to significantly ameliorate several pulmonary function parameters in a sub-group of 18 patients. It may be concluded, that after total laryngectomy significant abnormalities in pulmonary function have to be anticipated. We have found that these disturbances seem to be more pronounced with increasing age.

Pulmonary function pre- and post-total laryngectomy.

Pulmonary function pre- and post-total laryngectomy was assessed in 16 patients without overt inspiratory stridor preoperatively. It could be shown that total laryngectomy is associated with a significant decrease in vital capacity and in an increase in inspiratory flow-volume values 9 days postoperatively. The inspiratory values tended to increase slightly over the next half year. The measured expiratory flow-volume values were preoperatively already significantly lower than the predicted values, and no significant changes could be observed immediately after the operation nor after 6 months. These alterations have to be taken into account when judging the pulmonary function after total laryngectomy.

The influence of a heat and moisture exchanger (HME) on the respiratory symptoms after total laryngectomy.

The influence of a heat and moisture exchanger (HME) on the respiratory symptoms after total laryngectomy was studied in 42 patients. A significant reduction was found in the mean daily frequency of sputum production, forced expectoration in order to clean the airway and stoma cleaning after use of the HME for 6 weeks. Symptoms of fatigue and malaise decreased significantly, while social contact improved. Patients using oesophageal speech or an electrolarynx benefited more than patients using a voice prosthesis. The findings indicate that respiratory problems after total laryngectomy can be reduced significantly with the use of a device with heat and moisture exchanging properties. In turn, reduction of respiratory symptoms results in an improved quality of life.

Physical and psychosocial consequences of total laryngectomy.

The incidence and severity of respiratory symptoms after total laryngectomy and their influence on daily living were studied in 59 laryngectomized patients. Daily sputum production was the principal complaint of these patients (98%), followed by coughing (64%) and the need for frequent forced expectoration (more than 5 times a day) in order to clear the airway (57%). Frequent stoma cleaning (more than 5 times a day) was required by 37% of the patients. Significant correlation was found between respiratory symptoms, voice rehabilitation and several aspects of daily living, including fatigue, sleep problems, social contacts and psychological distress. These findings indicate that respiratory symptoms after total laryngectomy are both frequent and troublesome. The development of effective methods for minimizing and/or preventing such respiratory problems would contribute significantly to improving the quality of life of laryngectomized patients.