Feasibility and acceptance of a telehealth intervention to promote symptom management during treatment for head and neck cancer
Patients undergoing treatment for head and neck cancers have a myriad of distressing symptoms and treatment side effects which significantly alter communication and lower quality of life. Telehealth technology has demonstrated promise in improving patient–provider communication by delivering supportive educational content and guidance to patients in their homes. A telehealth intervention using a simple telemessaging device was developed to provide daily education, guidance, and encouragement for patients undergoing initial treatment of head and neck cancer. The goal of this article is to report the feasibility and acceptance of the intervention using both quantitative and qualitative measures. No eligible patients declined participation based on technology issues. Participants completed the intervention for over 86% of the expected days of use. Direct nursing contact was seldom needed during the study period. Satisfaction with the technology and the intervention was very high. In this study a telehealth intervention was shown to be feasible, well accepted, and regularly used by patients experiencing extreme symptom burden and declining quality of life as a result of aggressive treatment for head and neck cancer.
Funding and acknowledgments This research was funded in part by a grant from the National Cancer Institute, National Institutes of Health. This material is the result of work supported with resources and the use of facilities at the Louisville Veterans Affairs Medical Center. Equipment and technical systems were provided through a contract with Robert Bosch Healthcare.
Conflicts of interest The contents of this article do not represent the views of the Department of Veteran Affairs or the federal government. The researchers report no conflict of interest related to the technology used in this study.
Correspondence Barbara Head, PhD, University of Louisville School of Medicine, 511 South Floyd Street, Suite 110, Louisville, KY 40203; telephone: (502) 852–3014; fax: (502) 852–6300
Accrual rate
The number of individuals assessed for study eligibility, reasons for exclusion or noncompletion, and numbers included in the analysis were all recorded to examine acceptance of the intervention and identify issues with the intervention or technology affecting participation.
,Utilization
Feasibility was operationalized as device utilization using the percentage of days on which a participant responded to the Health Buddy. This was calculated using the number of days the participant responded to the telehealth device divided by the number of days the participant had the device and was expected to respond. These data were maintained and provided by the telehealth provider (Robert Bosch Healthcare).
Nurse-initiated contacts with participants and/or clinicians
The number of occasions on which a nurse decided to intervene was used as an indicator of feasibility under the premise that the goal of the intervention was to support and encourage patient-driven efforts to seek care for persistent or troubling symptoms. If a patient reported a symptom, he or she was given management information and encouraged to discuss problems further with the clinician either by phone or during clinic visits. If a patient continued to report an unresolved symptom or if the symptom required immediate intervention (ie, suicide threat), the research nurse reviewing responses would contact the patient and/or clinician to ascertain why and/or assist with its resolution. These nurse-initiated contacts should be infrequent if the intervention is achieving the goal of developing patient self-efficacy.
Satisfaction ratings
Items assessing satisfaction with the technology were also administered to participants via the telehealth messaging device. Questions related to satisfaction with the initial setup of the telehealth appliance were asked at the beginning of the intervention. Ongoing satisfaction with the device, messaging content, and the health-care provider were assessed every 90 days. The specific questions asked are detailed in Table 4.
Narrative data
Upon completion of the intervention, participants in the treatment group completed an exit interview using open-ended questions regarding the utility of the intervention, relevance of the algorithms, value or burden of item repetition in the algorithms, symptoms or problems experienced that were not addressed by the intervention, and general comments.
Poststudy survey
A final survey was mailed to participants several months after completion of the study, asking for additional feedback about the impact of the intervention. Specifically, participants (both treatment and control groups) were asked about their overall satisfaction with the treatment and services at the cancer center, their satisfaction with information received about their treatment, the response(s) received when they attempted contact with the health-care team after hours, the amount of support received, their current smoking and alcohol usage, and several demographic questions not earlier assessed or available through record review (years of education, highest degree, income range). Those receiving the intervention were also asked about the impact of the Health Buddy on their care and actions taken in response to the algorithms.
Demographic and medical information
Demographic information was collected using the initial survey, and information about the participant's medical history, condition, treatments received, treatment timing, complications, comorbidities, and treatment response was collected via retrospective medical record review subsequent to completion of the clinical trial.
Outcome measures
While outcomes of the clinical trial are not the subject of this article, the results of QOL and symptom burden measures for the treatment group only are included here because of their relationship with device utilization. The two measures included the Functional Assessment of Cancer Therapy–Head and Neck Scale and the Memorial Symptom Assessment Scale and were administered at baseline (before beginning treatment), mid-treatment, and posttreatment.
• Functional Assessment of Cancer Therapy–Head and Neck Scale (FACT-H&N). The FACT-G (general) is a multidimensional QOL instrument designed for use with all cancer patients. The instrument has 28 items divided into four subscales: Functional Well-Being, Physical Well-Being, Social Well-Being, and Emotional Well-Being. This generic core questionnaire was found to meet or exceed requirements for use in oncology based upon ease of administration, brevity, reliability, validity, and responsiveness to clinical change.30 Added to the core questionnaire is the head and neck–specific subscale, consisting of 11 items specific to this cancer site. A Trial Outcome Index (TOI) is also scored and is the result of the physical, functional, and cancer-specific subscales. List et al31 found the FACT-H&N to be reliable and sensitive to differences in functioning for patients with head and neck cancers (Cronbach's alpha was 0.89 for total FACT-G and 0.63 for the head and neck subscale in this study of 151 patients). Additionally, head and neck cancer patients found the FACT-H&N relevant to their problems and easy to understand, and it was preferred over other validated head and neck cancer QOL questionnaires.32 The FACT-H&N was chosen for this study because it (1) is nonspecific related to a treatment modality or subsite among head and neck cancers, (2) allows comparison across cancer diagnoses while still probing issues specific to head and neck cancer, (3) is short and can be completed quickly, (4) includes the psychosocial domains of social/family and emotion subscales as well as physical and functional areas, and (5) is self-administered.
• Memorial Symptom Assessment Scale (MSAS). This multidimensional scale measures the prevalence, severity, and distress associated with the most common symptoms experienced by cancer patients. Physical and emotional subscale scores as well as a Global Distress Index (GDI, considered to be a measure of total symptom burden) can be generated from patient responses. The MSAS has demonstrated validity and reliability in both in- and outpatient cancer populations.[33], [34] and [35] Initial psychometric analysis by Portenoy et al34 used factor analysis to define two subscales: psychological symptoms and physical symptoms with Cronbach alpha coefficients of 0.88 and 0.83, respectively; convergent validity was also established. It was chosen for this study because of its proven ability to measure both the presence and the intensity of experienced symptoms.[33], [35], [36], [37] and [38]
Data Analysis
Quantitative data were documented and analyzed using the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL), version 16. Descriptive statistics were calculated to describe the sample and assess study outcomes, including feasibility and acceptability of the intervention. To ascertain relationships between usage of the device and demographic and medical information, a series of correlational analyses using Spearman's rho were conducted. This nonparametric test was chosen over Pearson's r because of the small sample size, the lack of a normal distribution for several of the variables, and the ordinal nature of several of the variables. Multiple regression analyses were also planned, but lack of significant bivariate correlations precluded multivariate analysis.
Qualitative responses to open-ended questions were analyzed to identify themes and direct quotations illustrating those themes.
Descriptive analysis of the treatment group's responses to the outcome measures (QOL and symptom burden) was done to ascertain changes over the course of the intervention using the mean scores at baseline, during treatment, and posttreatment.
Results
Description of Participants
Participants randomly assigned to the intervention group (n = 45) were an average age of 59 years (±11.7), and most were covered by private (34%) or public (48%) insurance. On average, participants had completed 13.5 years (±3.0) of formal education. Thirty-nine (87%) of the participants were male and 91% were Caucasian.
With regard to medical information, participants were predominantly diagnosed with stage II cancers of the head and neck (36%). The most prevalent site was the larynx (12 patients), followed by the tongue and the base of the tongue (seven patients) and unknown primary (seven patients). The vast majority received chemotherapy (32, or 71%) and/or radiation (42, or 93%).
Additional details regarding demographic and medical characteristics of the sample are provided in Table 2.
