Pilot randomised controlled trial of the self-help plus stress management intervention among patients with breast and gynaecological cancer in Viet Nam: a study protocol.

introductionImplementation of low-intensity, evidence-based psychological interventions can help meet the mental health and psychosocial needs of people with cancer, especially in low-resource settings where there is a dearth of mental health specialists. In this study, we will conduct a feasibility randomised controlled trial (RCT) of the stress management intervention Self-Help Plus, which has been translated and adapted to Vietnamese, vSH+, among people newly diagnosed with breast or gynaecological cancer in Viet Nam. METHODS AND ANALYSIS: At six participating hospitals, individuals diagnosed with breast or gynaecologic cancer within the past year will be recruited, consented and randomised into either enhanced usual care (EUC) or EUC plus the vSH+ intervention, which consists of four sessions each lasting approximately 75 min. Quantitative surveys will be administered at three time points: enrolment/baseline (T0), after 6 weeks (T1) and after 4 months (T2). A qualitative evaluation component, which will include in-depth interviews with patients, implementers and healthcare staff and managers, as well as focus group discussions with caregivers, will assess the acceptability and feasibility of the vSH+ intervention. ETHICS AND DISSEMINATION: Ethical reviews for the study were obtained from Boston University, Hanoi University of Public Health (HUPH) and all the participating hospital sites. On completion of data collection and analyses, the research team will prepare and submit abstracts to scientific conferences as well as manuscripts to peer-reviewed journals. We will also conduct dissemination events to report the trial results to relevant stakeholders. TRIAL REGISTRATION NUMBER: NCT06398067.