Effects of a Self-Monitoring Quality of Life Intervention in Outpatients with Breast Cancer: A Preliminary Report of A Randomized Controlled Trial

OBJECTIVE: This preliminary report used data from a randomized controlled clinical trial to investigate the beneficial effects of a self-monitoring quality of life (SMQOL) intervention on communication, medical care and patient outcomes in Japanese women with breast cancer. METHODS: This study compared a SMQOL intervention group with a control group that received usual care after 4 months on self-efficacy aspects of patient–physician communication among outpatients with breast cancer in Japan using the Perceived Efficacy in Patient–Physician Interactions (PEPPI) questionnaire. Patients were randomly assigned to the intervention and control groups using permuted-block randomization. The intervention groups were asked to complete a paper-based quality-of-life (QOL) questionnaire in addition to the usual care provided in the control group. Analysis of covariance was used to assess the difference in PEPPI scores between the intervention and control groups. Additionally, subgroup analyses were performed for outpatients with breast cancer accompanied by depression or anxiety. RESULTS: In total, 232 patients were eligible for this study and randomized. Seven patients did not answer the PEPPI questionnaire at baseline after group allocation, leaving 225 patients for inclusion in the analyses. The modified intention-to-treat ITT analysis showed the SMQOL intervention had no significant effect on PEPPI total score (P = 0.226). We found a significant between-group difference in PEPPI total score in the anxiety group (P = 0.045), namely, the self-efficacy aspects of patient–physician communication of those with anxiety in the intervention group were better than for those in the control group after 4 months. CONCLUSION: Use of the SMQOL had beneficial effects on communication self-efficacy between patients and physicians for outpatients with breast cancer, those with anxiety.