The effectiveness of a psychological intervention targeting bereaved caregivers of cancer patients: Study protocol for the EMPOWER-Cancer-grief RCT.

BACKGROUND

Informal caregivers (e.g., family members) of cancer patients experience significant demands in time, energy and mental resources. While several interventions target cancer caregivers, most focus on distress, overlooking positive outcomes (e.g. resilience and post-traumatic growth). This study aims to test the feasibility, acceptability and effectiveness of an adapted version of the EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) intervention for protecting Cypriot bereaved cancer caregivers against distress and promoting positive outcomes.

METHODS

The study will follow an open trial and a posterior Randomized Controlled Trial (RCT) design whereby study participants will be randomized 1:1 to either the EMPOWER intervention or the control group arms. Eligible participants will be adult caregivers who experienced a cancer-related loss within the last 18 months and are at risk of prolonged grief disorder (PGD) (i.e., have high scores on the PG-13-R and TRIG). EMPOWER is a blended intervention combining evidence-based cognitive-behavioural approaches, psychoeducation, acceptance-based principles and meaning-centred grief therapy techniques. The adapted intervention (EMPOWER-Cancer-Grief) will consist of individual weekly face-to-face sessions delivered over a six-week period. Control group participants will attend a 1.5-h psycho-educational session. Outcomes will include depression and anxiety symptoms, PGD risk, resilience, post-traumatic growth and experiential avoidance. Data will be collected at baseline, post-treatment and one- and three-month's follow-ups post intervention.

DISCUSSION

Findings will provide insight into the intervention effectiveness for decreasing distress and increasing positive outcomes in cancer caregivers, and its feasibility and acceptability with Cypriot sample.

TRIAL REGISTRATION

ISRCTN12141154.