Evaluation of a telehealth psychological support intervention for people with primary brain tumour and their family members: Study protocol for a randomised controlled trial

Objective: There is a lack of research on interventions that address the specific psychosocial needs of people with brain tumour and their families. This paper describes the protocol for a pragmatic randomised control trial (RCT) evaluating the clinical efficacy and cost-effectiveness of the Making Sense of Brain Tumour program delivered via telehealth (Tele-MAST) relative to standard care. Methods: The 148 adults with primary brain tumour will be randomly allocated to the 10-session Tele-MAST videoconferencing program or standard care from a cancer counselling service. The primary outcome is level of depression and secondary outcomes are quality of life, mental health and incremental cost per quality-adjusted life year. The mental health and quality of life of family members will also be assessed. Assessments will be conducted at pre-intervention, post-intervention (primary endpoint), 6-weeks post-intervention and 6-months post-intervention. The main analysis will determine whether the Tele-MAST intervention is more effective than standard care at post-intervention, and whether these effects are sustained at follow-up. Conclusion: Results will indicate whether the Tele-MAST program is associated with better clinical outcomes and is more cost-effective than existing cancer support services. Such outcomes will contribute to effective and accessible psychosocial care for the brain tumour population.