This pilot randomized controlled trial evaluated the feasibility, acceptability, and preliminary efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) for chronic pain in 60 cancer survivors (mean age 60.3 years, 75% female) with moderate-to-severe pain. Participants were randomized to one of three MORE formats (16-hour, 8-hour, or 2-hour) or a waitlist control, with follow-up at 12 weeks.
Feasibility metrics were promising: enrollment rate was 70.6%, and assessment completion was 91%. Treatment adherence varied by format: 64.3% for 16-hour, 81.3% for 8-hour, and 100% for 2-hour sessions. For pain outcomes, within-group reductions favored MORE over control for both pain interference (-1.22 vs -0.81) and pain severity (-1.31 vs -0.85), though these differences were not statistically significant. All three MORE formats showed significant within-group reductions, suggesting a dose-response effect.
Safety and tolerability data were not reported. Key limitations include the pilot nature of the study and small sample size, which limit statistical power and generalizability. Funding and conflicts of interest were not reported.
For practice, this study supports the feasibility and acceptability of offering MORE to cancer survivors with chronic pain in various time formats. However, the preliminary efficacy signals for pain reduction require cautious interpretation due to non-significant between-group differences and the pilot design. Larger, definitive trials are needed to establish efficacy.
View Original Abstract ↓
CONTEXT: Chronic pain affects many cancer survivors yet remains underdiagnosed and inadequately managed. Existing treatments (e.g., opioids, NSAIDs) carry risks like addiction and limited long-term relief, while non-pharmacological options show modest effectiveness. Given these limitations innovative, evidence-based interventions are needed. Mindfulness-Oriented Recovery Enhancement (MORE), a multimodal intervention targeting neurocognitive mechanisms underlying chronic pain, has demonstrated effectiveness in noncancer populations but has not been studied in cancer survivors.
OBJECTIVE: This pilot randomized controlled trial evaluated the feasibility, acceptability, and explored preliminary efficacy of MORE on pain interference and severity in cancer survivors.
METHODS: Sixty patients with history of any type of cancer living with no evidence of disease or stable oncological disease with moderate-to-severe pain (mean age 60.3 ± 11.8 years; 75% female) were randomized 3:1 to one of three MORE formats (16-hour, 8-hour, or 2-hour) or waitlist control (WLC). Feasibility was assessed through enrollment, assessment completion, and adverse events rates. Acceptability was evaluated by treatment adherence, at-home practice, and satisfaction (Net Promoter Score). Pain interference and pain severity were measured with the Brief Pain Inventory at baseline and weeks 1, 4, 8, and 12. Descriptive statistics summarized feasibility and acceptability; constrained linear mixed models tested efficacy and dose-response effects.
RESULTS: MORE demonstrated feasibility with high enrollment (70.6%) and assessment completion (91%) rates. Treatment adherence was high (16-hour: 64.3%; 8-hour: 81.3%; 2-hour: 100%), with satisfaction highest in the 16-hour format. Within-group reductions in pain interference (-1.22 vs. -0.81) and severity (-1.31 vs. -0.85) favored MORE over WLC, though not significant. A dose-response effect was observed, with all MORE formats yielding significant reductions in pain interference and severity.
CONCLUSIONS: These findings support the feasibility and acceptability of MORE for cancer survivors and suggest potential efficacy in reducing chronic pain among cancer survivors.
TRIAL REGISTRY/NUMBER: ClinicalTrials.gov/ NCT05877521.