protocol for a pilot randomised controlled trial of an online cancer bereavement group.

BACKGROUND: The loss of a loved one to cancer brings unique difficulties that affect the bereavement experience. Mixed evidence exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to accessing support including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible means of providing grief support at the individual and group level. Research supports the effectiveness of online groups for those bereaved by cancer although most existing studies have examined peer-led online groups only, while empirical evidence on therapist-led online groups is still limited. This paper describes the protocol for a pilot trial evaluating the feasibility, acceptability, and exploratory effects of delivering online therapy groups for those bereaved by cancer. METHODS: A longitudinal pilot randomised controlled trial (RCT) design will be used. A total of 100 adults who have lost a loved one to cancer will be randomised to receive the intervention immediately or after a delay three months later. Participants will engage in an eight-session online therapeutic group over 12 weeks, integrating cognitive-behavioural therapy, compassion-focused therapy, and grief models. Primary outcomes are feasibility (recruitment, retention, adherence, and data completeness) and acceptability (session attendance and participant ratings of helpfulness). Secondary outcomes include changes in grief intensity, depression, anxiety, post-traumatic stress, self-compassion, and social disconnection, measured at baseline, post-intervention, and three months post-intervention. Some measures such as depression, anxiety, grief intensity, and self-compassion will also be collected after each session. Feasibility and acceptability metrics will be assessed using pre-defined thresholds, and exploratory between-group differences in intervention outcomes will be examined. DISCUSSION: This pilot trial will evaluate whether a therapist-led online group intervention is feasible and acceptable for adults bereaved by cancer. It is hypothesised that participants will show improvements in psychological outcomes post-intervention compared to waitlist controls, with effects being maintained at follow up three months later. Our findings will help to inform the design of a future full-scale RCT to establish efficacy. TRIAL REGISTRATION: Feasibility and Outcomes of Therapist-led Online Cancer Bereavement Groups (NCT07002424), ClinicalTrials.gov, registered 3 June 2025, retrospectively registered https://clinicaltrials.gov/study/NCT07002424.