Discussion
cancer
CANCER, SECONDARY
To our knowledge, this is the first fully powered RCT of a psychosocial intervention for NF. Participation in the 3RP-NF and HEP-NF was associated with similar improvements from baseline to after treatment in primary (physical health and psychological QOL) and secondary (social relationships and environmental QOL) outcomes (small to medium ESs). Improvements persisted through 12 months, but the magnitude of improvement decreased for those in the HEP-NF group while it was sustained (primary outcomes: physical health and psychological QOL; and secondary outcome: social relationships QOL) or increased (secondary outcome: environmental QOL) for those in the 3RP-NF group. The 3RP-NF participants demonstrated within-group improvements in all primary and secondary QOL domains from baseline to 12 months, which were clinically meaningful. Participation in the 3RP-NF intervention was associated with substantially more improvement from baseline to 12 months than with the HEP-NF for all outcomes (small to medium ESs), except for the primary outcome of psychological QOL, where improvement was similar. Results demonstrate that the 3RP-NF intervention has durable benefit that exceeds that of health education. Results were similar when accounting for treatment responders based on the MCID developed for cancer.Although we found no between-group differences from baseline to after the test in improvement in QOL domains, the magnitude of differences widened over time such that between-group differences from baseline to 12 months favored the 3RP-NF intervention. This outcome was due to either continued improvement in the 3RP-NF group (secondary outcomes) or deterioration in the HEP-NF group (primary outcomes; small to medium ESs). Only 3RP-NF participants showed improvements from baseline to 12 months that were also clinically meaningful. These findings highlight the effect of support and attention from the therapist in both groups. The continued improvement in QOL in the 3RP-NF group after the intervention ended and support from group members and therapist was removed highlights the importance of the mind-body skills taught in the 3RP-NF. It is also possible that the 3RP-NF group demonstrated improvement through 12 months because more than 8 weeks are needed to translate into improvement in QOL. This hypothesis is best illustrated for the secondary outcome of environmental QOL, which had the steepest slope of increase in the 3RP-NF group after the intervention ended. This outcome assessed access to financial resources, transportation, employment, and housing, which require time to achieve. Future studies should explore mechanisms of improvement through 3RP-NF skills to formally test this hypothesis.