IMPACT OF KNOWLEDGE ENHANCEMENT PROGRAM (KEP) ON STRESS AND QUALITY OF LIFE AMONG BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED TRIAL PILOT STUDY REPORT

Abstract

Background: Breast cancer is the most widespread cancer worldwide, with around 2.3 million fresh cases reported in 2020. Breast cancer survivors frequently experience psychological distress, stress, and impaired quality of life (QOL) during and after treatment. Educational and supportive interventions such as Knowledge Enhancement Programs (KEP) may assist survivors in coping with disease-related challenges; however, evidence from randomized controlled pilot studies remains limited.

Objective: To assess the feasibility and preliminary effectiveness of a Knowledge Enhancement Program (KEP) on knowledge, stress, and quality of life among breast cancer survivors in preparation for a full-scale randomized controlled trial.

Methods: A randomized controlled pilot study was conducted among 22 newly diagnosed breast cancer survivors attending a tertiary care hospital in Goa, India. Participants were selected using purposive sampling and randomly allocated into intervention (n = 11) and control (n = 11) groups using block randomization. The intervention group received the Knowledge Enhancement Program in addition to routine care, while the control group received routine care alone. Outcomes including knowledge, stress, and quality of life were assessed at baseline (T0), immediate post-test at 4 weeks (T1), and follow-up at 12 weeks (T2) using validated tools under single-blinded conditions. Descriptive analysis was performed using per-protocol analysis, while inferential statistics were analyzed using intention-to-treat principles.  The Shapiro–Wilk test was used to assess the normality of the study variables as the sample size was small. Since several key variables were not normally distributed ,Non-parametric tests including Mann–Whitney U test, Wilcoxon Signed-Rank test, Friedman test, and Spearman’s correlation were used for analysis.

Results: In descriptive analysis the intervention group demonstrated marked improvement in mean knowledge scores from baseline to 12 weeks (5.5 to 11.7), compared with minimal improvement in the control group (5.0 to 6.7). Stress scores reduced in both groups, with greater reduction observed in the intervention group (38.8 to 26.2). In inferential statistics the intervention group demonstrated statistically significant improvement in knowledge scores from baseline to post-test (Z = -2.504, p = 0.012) and follow-up (Z = -2.560, p = 0.010), indicating sustained knowledge retention. Stress scores significantly decreased at post-test (Z = -2.549, p = 0.011) and follow-up (Z = -2.395, p = 0.017). Quality-of-life scores showed statistically significant improvement at follow-up compared to baseline (Z = -2.803, p = 0.005). Friedman test findings also revealed significant differences across time points for knowledge (χ² = 10.947, p = 0.004), stress (χ² = 6.684, p = 0.035), and quality of life (χ² = 8.600, p = 0.014) among intervention participants. In contrast, the control group demonstrated no statistically significant improvements in knowledge and quality of life across repeated assessments. Correlation analysis among all participants revealed a statistically significant moderate positive association between knowledge and stress at follow-up assessment (r = 0.480, p = 0.024).

Conclusion: The Knowledge Enhancement Program demonstrated promising effects in improving knowledge and reducing stress among breast cancer survivors and was found to be feasible and acceptable for implementation in the main randomized controlled trial. Although improvements in quality of life were observed, statistically significant changes may require longer follow-up duration. The pilot findings support proceeding with the main study with minor methodological modifications. The findings support the implementation of a larger randomized controlled study to further evaluate the long-term impact of structured educational interventions on psychosocial outcomes among breast cancer survivors.