Development and usability testing of a web-based self-management intervention for oral cancer survivors and their family caregivers.

Oral cancer (OC) survivors experience debilitating side effects that affect their quality of life (QOL) and that of their caregivers. This study aimed to develop and evaluate a dyadic, web-based intervention to improve survivor self-management and survivor/caregiver QOL. A qualitative needs assessment (semi-structured interviews) with 13 OC survivors and 12 caregivers was conducted to discern information and support needs as well as preferences regarding website features and tools. Results using Grounded Theory analysis showed that OC survivors and caregivers: (1) want and need practical advice about managing side effects; (2) want to reach out to other survivors/caregivers for information and support; and (3) have both overlapping and unique needs and preferences regarding website features. Usability testing (N = 6 survivors; 5 caregivers) uncovered problems with the intuitiveness, navigation and design of the website that were subsequently addressed. Users rated the website favourably on the dimensions of attractiveness, controllability, efficiency, intuitiveness and learnability, and gave it a total usability score of 80/100. Overall, this study demonstrates that OC survivors and caregivers are interested in using an online programme to improve QOL, and that providing tailored website content and features based on the person's role as survivor or caregiver is important in this population.

Long-term swallowing problems after organ preservation therapy with concomitant radiation therapy and intravenous hydroxyurea: initial results.

OBJECTIVE: To evaluate the long-term effects on swallowing function of concomitant continuous infusion hydroxyurea and hyperfractionated radiation therapy used to treat advanced head and neck carcinoma. DESIGN: A prospective evaluation of swallowing function was performed on an inception cohort by analyzing posttreatment videoflouroscopic swallow function studies using radiological descriptors for pharyngeal transport abnormalities and temporal measures of structural movements, as well as by conducting patient interviews to assess alimentation, more than 1 year after tumor treatment (range, 52-124 weeks; median, 70 weeks). SETTING: Academic tertiary care referral medical center. PATIENTS: Ten patients, aged 44 to 71 years, with stage III and IV squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. MAIN OUTCOME MEASURE: Radiographic and temporal swallow abnormalities, as well as functional status, were documented and compared with published norms and results of earlier swallowing studies when possible. RESULTS: Pharyngeal transport dysfunction and anterior segment abnormalities, manifested by epiglottic dysmotility, vallecular residue, laryngeal penetration, or aspiration, were evident in all 10 patients. Posterior segment abnormalities, such as pharyngeal stasis, constrictor dysmotility and piriform residue were documented in 8 patients. Three patients developed late aspiration, and the majority of patients showed persistent or worsened delay in laryngeal movement compared with their earlier posttreatment evaluations. Also, 3 patients developed a hypopharyngeal stricture, and 6 patients continued to require gastrostomy tube supplementation beyond 1 year. There was no association between site of primary, duration to swallowing evaluation, and severity of dysfunction. CONCLUSION: Prolonged and debilitating functional swallowing abnormalities may occur after this aggressive concomitant chemotherapy and radiotherapy regimen.

Pharyngeal transport dysfunction consequent to an organ-sparing protocol.

OBJECTIVE: To investigate the effects of a protocol of concomitant intravenous hydroxyurea and hyperfractionated, accelerated, external-beam radiation therapy on the swallowing mechanism of patients with advanced-stage head and neck cancer. DESIGN: Posttreatment videofluoroscopic swallow function studies, using images of single-bolus swallows of low-density liquid barium, were analyzed in real time, slow motion, and frame by frame using an integrated system that allows objective analysis of video recordings through image processing and digitization (Kay Elemetrics Computerized Swallowing Station). Radiological descriptors were used for pharyngeal transport abnormalities, and temporal measures were obtained of structural movements. SETTING: Academic, tertiary care, referral medical center. PATIENTS: Fifteen consecutive patients with previously untreated, stages III and IV, nonmetastatic squamous cell carcinoma of the head and neck who underwent a phase 1 study of prolonged infusion hydroxyurea therapy in combination with hyperfractionated, accelerated external-beam radiation therapy for their disease. RESULTS: All patients had anterior pharyngeal segment dysfunction, characterized by no epiglottic movement and slowed laryngeal motility (1.011 +/- 0.379 seconds [mean +/- SD). Anterior pharyngeal dysfunction was more severe in patients with primary tumors of the hypopharynx than in those with cancer of the oropharynx. Twelve (80%) of our patients demonstrated posterior pharyngeal segment dysfunction characterized by impaired pharyngeal constrictor motility. All 15 patients displayed pharyngeal stage abnormalities that limited bolus transport and clearance. CONCLUSIONS: Severe pharyngeal physiological abnormalities were present that led to impaired bolus transport and that were frequent and debilitating consequences of this organ-sparing protocol. Long-term follow-up of this group will be required to assess the permanence of the abnormalities.

A phase I clinical trial of prolonged infusion of hydroxyurea in combination with hyperfractionated, accelerated, external radiation therapy in patients with advanced squamous cell cancer of the head and neck.

BACKGROUND: Preclinical data suggested that sustained inhibition of the anabolic enzyme, ribonucleotide reductase (RR), by hydroxyurea (HU) may be critical for the anticancer effects of the drug. A phase I trial of continuous infusion HU with concomitant hyperfractionated, accelerated radiation therapy (CHU-CHRT) was initiated to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of HU in patients with locally advanced squamous cell carcinoma (SCC) of the head and neck. METHODS: Patients were required to have histologically-documented and radiographically-staged locally advanced SCC of the hypopharynx (AJC stages II, III or IV), oropharynx (AJC stage IV), or oral cavity (AJC stage IV) not amenable to reasonable surgical resection. Eligible patients had adequate bone marrow, hepatic, and renal function and had to give informed consent. Concomitant, hyperfractionated, accelerated radiation therapy (CHRT) consisted of 1.2 Gy BID (6 hour minimum interfraction interval) on weekdays and 1.2 Gy delivered daily on the weekends to a total tumor dose of 74.4 Gy. Continuous infusion hydroxyurea (CHU) was administered at 0.25-0.375 mg/m2/min as a continuous intravenous infusion daily for 5 days with weekends days off for the duration of the radiation therapy. The dose of HU was increased by 0.125 mg/m2/min between dose levels until DLT was reached in 2/6 patients. If the primary had a complete clinical response and biopsies were negative, planned neck dissections were performed. RESULTS: Fifteen patients were enrolled and are evaluable. The initial dose level, 0.25 mg/m2/min was tolerated by 3/3 patients. At 0.375 mg/m2/min, 3/6 patients experienced grade 3-4 infections, with one patient having a non-fatal, subendocardial infarction. At 0.313 mg/m2/min, no patient experienced DLT. CONCLUSION: The MTD for CHU-CHRT was 0.313 mg/m2/min. The toxicities were primarily mucosal and a phase II study is in progress.