Abstract
IMPORTANCE: Psychoeducational interventions (PEIs), which provide both information and emotional and psychosocial support, may address the unmet needs of the caregivers of adolescent and young adult patients with cancer. OBJECTIVE: To explore the effects of an instant messaging-delivered PEI on anxiety, depression, quality of life (QOL), and coping and determine whether the intervention reduces caregivers' unmet needs. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial using an intention-to-treat protocol was conducted from April 1 to September 14, 2022, in a tertiary cancer hospital in China and included caregivers of patients diagnosed with cancer at age 15 to 39 years recruited using convenience sampling. INTERVENTION: Caregivers were allocated 1:1 using a randomized block scheme to the intervention or control group. The intervention group received a 5-week PEI and usual care, whereas the control group received only usual care. The PEI was delivered through articles and calls through an instant messaging application. MAIN OUTCOMES AND MEASURES: The primary outcomes were changes in the levels of caregivers' anxiety and depression, measured using the 7-Item Generalized Anxiety Disorder Scale and the Patient Health Questionnaire 9, respectively. The secondary outcomes were changes in the levels of caregivers' QOL, coping, and unmet needs. RESULTS: Of the 160 participants, 92 (57.5%) were male; mean (SD) age was 40.27 (8.33) years. Compared with the control group, the intervention group had significantly greater reduction in severity of anxiety (B = -3.231; 95% CI, -4.746 to -1.716; P < .001) and depression (B = -3.253; 95% CI, -5.052 to -1.454; P < .001), smaller reduction in QOL (B = 13.574; 95% CI, 0.488-26.661; P = .04), and greater reduction in unmet needs (B = -12.136; 95% CI, -18.307 to -5.965; P < .001) after the intervention. Twelve weeks after baseline, the intervention group demonstrated a significantly greater reduction only in severity of anxiety (B = -1.890; 95% CI, -3.382 to -0.397; P = .01). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of a mobile instant messaging-delivered PEI, caregivers' unmet needs, anxiety, and depression decreased significantly and QOL declined at a significantly slower rate immediately after the intervention in the intervention group compared with the control group. A sustained effect on anxiety was observed 12 weeks after baseline. TRIAL REGISTRATION: Chinese Clinical Trial Registry identifier: ChiCTR2200055951.