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: A total of 111 breast cancer patient-spouse caregiver dyads completed the intervention (56 in the intervention group and 55 in the control group). Linear mixed model analysis showed that the intervention reduced unmet needs in breast cancer patient–spousal caregiver dyads over time compared with the control group (group × time interaction: β =− 4.90, p < 0.001). Patients and spousal caregivers exhibited different trajectories of unmet needs over time (time × role interaction: β =3.71, p =0.004). Multilevel model analysis showed that, compared with the control group, the intervention group demonstrated significant improvements in couple communication problems, quality of life, anxiety, and depression (all p < 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. Keywords: breast cancer, unmet needs, supportive care, spouse caregivers, dyadic intervention