PROMIS and legacy measures compared in a supportive care intervention for breast cancer patients and caregivers: Experience from a randomized trial.

OBJECTIVE: Accurate and efficient measurement of patient-reported outcomes is key in cancer symptom management trials. The newer Patient Reported Outcomes Measurement Information System (PROMIS) and previously developed measures of similar conceptual content (legacy) are available to measure symptoms and functioning. This report compares the performance of two sets of measures, PROMIS and legacy, in a recently completed trial of a supportive care intervention that enrolled breast cancer patients and their friend or family caregivers. METHODS: Patient-caregiver dyads (N = 256) were randomized to either reflexology delivered by caregivers or usual care control. Post-intervention, PROMIS and legacy measures of symptoms and functioning were analyzed in relation to trial arm, while adjusting for baseline values. Responsiveness of the two sets of measures was assessed using effect sizes and P-values for the effect of trial arm on patients' and caregivers' symptom and functioning outcomes. RESULTS: Similar conclusions about intervention effects were found using PROMIS and legacy measures for pain, fatigue, sleep, anxiety, physical, and social functioning. Different conclusions were obtained for patient and caregiver depression: legacy measures indicated the efficacy of reflexology, while PROMIS depression measure did not. CONCLUSION: Evidence of similar responsiveness supports the use of either set of measures for symptoms and functioning in clinical and general populations. Differences between PROMIS and legacy measures of depression need to be considered when choosing instruments for use in trials of supportive care interventions and in clinical practice.

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

OBJECTIVE: In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. METHODS: Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. RESULTS: Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. CONCLUSIONS: While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd.