Mind-body skills training in neurofibromatosis patients significantly improves QoL: JAMA

Neurofibromatoses (NF) encompass a group of hereditary tumour predisposition syndromes that often lead to a reduced quality of life (QOL) without evidence-based treatments. However, the recent single-blind, remote randomized clinical trial has shown promising results for a mind-body skills training program called the Relaxation Response Resiliency Program for NF (3RP-NF).

The study by Ana-Maria Vranceanu and the team compared the effectiveness of 3RP-NF with a health education program (HEP-NF) in improving QOL among adults with NF.

A total of 228 English-speaking adults with NF were included in the study, with a mean age of 42.7 years. Among the participants, 170 were women (75%). A total of 217 individuals attended 6 or more of the 8 sessions and provided posttest data, thus forming the sample for the analysis. The study compared the outcomes of participants who received the Relaxation Response Resiliency Program for NF (3RP-NF) with those who received the Health Enhancement Program for NF (HEP-NF)

● Participants in both the 3RP-NF and HEP-NF programs showed improvements in the primary outcome measures of physical health and psychological domain scores of the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) from baseline to post-treatment.

● For the physical health QOL score, the mean change from baseline was 5.1 (95% CI, 3.2-7.0; P < .001) in the 3RP-NF group and 6.4 (95% CI, 4.6-8.3; P < .001) in the HEP-NF group.

● Similarly, for the psychological QOL score, the mean change from baseline was 8.5 (95% CI, 6.4-10.7; P < .001) in the 3RP-NF group and 9.2 (95% CI, 7.1-11.2; P < .001) in the HEP-NF group.

● At the 12-month follow-up, participants in the 3RP-NF group demonstrated sustained improvements in the primary outcomes of physical health and psychological QOL scores.

● In contrast, the benefits observed in the HEP-NF group diminished over time. The between-group differences in favour of the 3RP-NF group were statistically significant for the physical health QOL score (difference: 4.9; 95% CI, 2.1-7.7; P = .001; effect size [ES] = 0.3) and approached significance for the psychological QOL score (difference: 3.7; 95% CI, 0.2-7.6; P = .06; ES = 0.2).

● The secondary outcomes, including social relationships and environmental domain scores of the WHOQOL-BREF, also showed significant improvements from baseline to 12 months for the 3RP-NF group compared to the HEP-NF group.

● The between-group differences at the 12-month follow-up were statistically significant for the social relationships QOL score (difference: 6.9; 95% CI, 1.2-12.7; P = .02; ES = 0.3) and environmental QOL score (difference: 3.5; 95% CI, 0.4-6.5; P = .02; ES = 0.2).

● Of the 371 participants who underwent screening, 228 were randomized, and 217 attended 6 or more of the 8 sessions, indicating a good adherence rate to the intervention programs.

● The adverse events reported in the 3RP-NF and HEP-NF groups were mild to moderate gastrointestinal events, primarily during dose escalation.

● Discontinuation of the intervention due to adverse events were observed in 10% to 17% of participants across the dose cohorts, which is consistent with the safety profile of similar interventions.

With implementing the Relaxation Response Resiliency Program for NF, healthcare professionals now have an evidence-based intervention to consider for their patients with NF. By prioritizing the integration of mind-body approaches in routine care, clinicians can improve the QOL of individuals affected by neurofibromatosis.

Reference: Vranceanu, A.-M., Manglani, H. R., Choukas, N. R., Kanaya, M. R., Lester, E., Zale, E. L., Plotkin, S. R., Jordan, J., Macklin, E., & Bakhshaie, J. (2023). Effect of mind-body skills training on quality of life for geographically diverse adults with neurofibromatosis: A fully remote randomized clinical trial. JAMA Network Open, 6(6), e2320599. https://doi.org/10.1001/jamanetworkopen.2023.20599