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

Abstract Background Patients who undergo surgery for cancer of the head and neck and their families face complex and difficult challenges and are at risk of anxiety and depression and inability to cope with symptom and treatment burden. Information available to support them is not flexible enough to adjust to individual need. Design/Methods A randomised clinical trial pre and post intervention design, comparing the use of a tailored DVD intervention, provided preoperatively and used throughout the post- operative period, with usual treatment. One hundred fifty-six individuals or partner couples will be randomly recruited into either the intervention or control group. A survey will be administered at three time points, preoperatively, post operatively and 3 months post-surgery. Anxiety and empowerment are the primary outcome measures. Qualitative data about use of the resource will be gathered by phone interview. Discussion This is the first study to rigorously evaluate the impact of a DVD intervention for this group of patients and their family members. The study will help to understand the impact of information usage on patient and family well- being and test a means by which to evaluate information and education resources for this and other cancer patient groups. Trial registration ACTRN12614001104640 . Date registered: 17/10/2014