Study Protocol: Evaluation of a DVD intervention designed to meet the informaton needs of patients with head and neck cancer and their partner, carer and families

Head and neck cancer has a global burden of more than 550,000 cases annually [1]. Incidence rates vary between countries due to increased rates with tobacco epidemics currently peaking in some regions while declining in others where tobacco use has peaked and is falling, and with the increasing incidence associated with human papillomavirus infection [2]. Head and neck cancers diagnosed in Australia in 2009 (3896) accounted for 3.4 % of all cancers diagnosed (114,137), with the number of head and neck cancers diagnosed increasing between 1982 (2475) to 2009 (3896). This increase is attributed to an increasing aging population [3].

The treatment for head and neck cancer is often drastic and debilitating, with surgery effecting vital functions such as swallowing and breathing, as well as speech. This frequently results in poorer patient outcomes in terms of quality of life [4] that have long term impact and require significant lifestyle and psychological adjustment by patients and families [5].

Evidence points to the need for significant and broad ranging support for this group of patients who can often be overlooked in large scale cancer support programs [6]. In many cases, the complexity of the physical and functional impairments resulting from head and neck cancer or the treatment can lead to high levels of anxiety, impacting negatively on self-image, self-efficacy [7] social isolation, and depression [8]. Holland and Weiss [9] have recommended that psychosocial aspects should be integrated into routine cancer care for these patients throughout their illness trajectory. Provision of information to cancer patients has been shown to reduce anxiety and support decision making [10]. However the amount of evidence available to support information interventions is small and limited by poor quality and lack of attention to practical implementation [11].

The availability, content and quality of written information specific to the individual needs of patients with head and neck cancer have been repeatedly identified as areas requiring attention [12, 13].^, It is well-documented that patients require personalized information to be able to participate optimally in decision-making and self-care and that information giving needs to be informed by the preferences of patients and families and matched to significant events that occur across the illness trajectory [5].

The role of partners and family members in supporting cancer patients is also recognised as central to patient well- being [10]. They may also be impacted by the burden of care and treatment [14], and hence require timely targeted information that increases their understanding and capacity to contribute to care. Carers are also at risk of psychological distress, with reports of up to 70 % of carers of cancer patients experiencing depression and 39 % reporting anxiety [15, 16]. A recent review identified that some partners and family caregivers’ most prominent needs pertain to curtailing the impact of their roles and responsibilities on daily living and information (e.g., what to expect) [17].

A recent review of online interventions for cancer patients finds that the majority of evaluations of information related interventions focus on patient usage and satisfaction, with few reporting quantifiable clinical outcomes [18]. Additionally, there are very few studies reporting specifically on the impact on clinical outcomes. For example, [19] report on a web-based psycho-educational program for cancer patients and their caregivers that delivered a post-intervention decrease in emotional distress, and improvements in quality of life indicators. Similarly, a Korean internet-based cancer-related fatigue program, reports significant improvements in fatigue, quality of life, and anxiety for the intervention group [20]. Another program that provided head and neck cancer patients with educational resources, the ability to engage with other patients via an online forum, and an at-home monitoring system, found a significant improvement in quality of life indicators after 6 weeks compared to the control group, although this difference was not sustained after 6 months [21]. However, given the design of this study, the effect of providing educational resources alone could not be assessed. While internet-based educational programs for cancer patients certainly offer promise, variable skills in technology use have been highlighted as a confounding factor in the assessment of such intervention programs, particularly for an older cohort [18]. An Australian intervention providing prospective chemotherapy patients with a DVD preparing them for treatment and possible side effects, found benefits in improving patients’ confidence in coping with cancer, although it did not reduce pre-treatment anxiety. Nonetheless, the authors reinforce the need to provide patients with informational resources such as DVDs, as an adjunct to education provided directly by clinicians, given increasing challenges resulting from workforce shortages and the greater emphasis on ambulatory care [22].

In response to clinicians’ concerns regarding the unmet needs of patients who undergo surgery for head and neck cancers we undertook a qualitative study to identify the needs of this group of patients and their family members [5]. An important finding from this study was participant’s reports of the inadequacy of information provided to them and the difficulties they had understanding and using information effectively. Information is often developed for or by health professionals and hence may use language not easily understood by patients and their families. The needs identified included the need to feel in control and to have information about what to expect at various stages. Concerns varied according to the tumour site and the nature of surgery and any adjuvant therapies. Because of the many and varied types of surgery it was not surprising that very few people felt they had information specific to their needs [5]. These finding supports research that highlights the importance of accurate, comprehendible and timely information pre-surgery and post-surgery for head and neck cancer patients [23, 24]. At present there appears to be no systematic way for patients and partners to gain information at the various stages across the surgical journey and in accordance with their changing needs. The study described in this protocol aims to evaluate a DVD resource produced for this purpose.

Although blinding is not possible as participants will be aware if they received the intervention DVD or not, it is anticipated that contamination will be minimized because participants will be mainly using the study intervention at home. A particular difficulty for the study is the low numbers of patients who undergo surgery and hence it may take time to get the required numbers.

Meeting the information needs of patients who undergo surgery for head and neck cancers and their families is challenging due to the diversity of tumour site, nature and degree of surgical intervention and unique personal characteristics mean that needs differ from person to person. Further, needs vary over time as confidence levels change and new challenges are encountered.

Improvements in models of care which including the introduction of MDT meetings [27] have increased the opportunities for communication and information provision. However, appointment times are often short and information may not always presented in a way that helps patients and families consider what the experience will mean for them [5]. It is anticipated that using the DVD to inform conversations will help to reduce some of these barriers, helping patients to anticipate and be prepared for the challenges they will face and to gather and strengthen their support networks. Partners and family members’ needs may differ from those of the patient and meeting their needs also contributes to positive outcomes for patients [17]. While some needs have been shown to be similar to those of cancer patients, they may differ in detail and perspective [10] Partners and family members report being more concerned with non-medical topics such as coping with cancer and impact on relationships. The systematic review conducted by [10] highlighted the lack of studies reviewing the information needs of partners and family members in relation to cancers other than breast and prostate. Although not specific to head and neck cancer this review highlights the importance of monitoring needs of both groups and ensuring information is provided that supports the patient and their supporting network.

Little empirical evidence exists that compares means of providing information for patients and partners. The findings of this study will provide evidence that will improve the provision and use of information for patients and their families. It will highlight the role of timely salient information provision in improving patient and carer outcomes after surgery by demonstrating if and how the intervention leads to their increased capacity to cope with and manage their care. In particular it will indicate the impact of the intervention on psychological well-being. It will also demonstrate the effectiveness of an approach to evaluating the use of resources by patients and families. It is anticipated that following evaluation the DVD and accompanying resources will be made widely available for patient benefit nationally and internationally.