Supportive Intervention for Unmet Needs Among Breast Cancer Patients and Their Spousal Caregivers: A Randomized Controlled Trial

Purpose: This study aims to evaluate the effectiveness of a supportive intervention program designed based on Existence-Relatedness-Growth theory and the Supportive Care Needs Framework in reducing unmet needs among breast cancer patients and their spouse caregivers. Patients and Methods: This study was a two-arm, single-blind randomized controlled trial. Between December 2024 and August 2025, 122 breast cancer patient-spousal caregiver dyads were recruited from the Affiliated Hospital of Jiangnan University and randomly assigned to an intervention or control group (61 dyads each). The intervention group received a 6-week dyadic supportive care program targeting unmet needs, delivered by the principal investigator in weekly 60-minute sessions. The control group received routine care. Primary outcome was unmet needs; secondary outcomes included communication problems, quality of life, anxiety, and depression. All outcomes were assessed at baseline and post-intervention. Linear mixed models analyzed the primary outcome, while multilevel models evaluated intervention effects on secondary outcomes. Results: <0.05). Conclusion: The unmet needs supportive intervention program for breast cancer patient-spousal caregiver dyads can effectively reduce unmet needs and enhance couple communication, thereby improving their quality of life and alleviating anxiety and depression.