Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers

Abstract

A metastatic cancer diagnosis is associated with high levels of distress in patients and caregivers. Mindfulness interventions can reduce distress and improve quality of life in cancer patients. However, standard mindfulness training relies on in-person instruction, which is often not practical for either patients receiving chemotherapy or their caregivers. In the Being Present single arm pilot study, we designed and tested an 8-week audio-based mindfulness meditation program for patients with metastatic colorectal cancer receiving chemotherapy with or without a participating caregiver. The study accrued 33 of 74 (45%) eligible patients consenting together with 20 family caregivers (53 participants total) within nine months. Forty-one participants were evaluable (77%); 10 of 12 cases of attrition were attributable to hospitalization or death. Median participant age was 51 (range 21-78 years); 38% were men. Baseline levels of distress were similar in patients and caregivers. The top reasons for participation cited in pre-intervention interviews were to increase relaxation/calm, improve mood/emotions, and reduce stress/anxiety. In measures of adherence, 59% of responses to weekly texts asking: "Have you practiced today?" were "Yes" and 59% of interviewees reported practicing >50% of the time. Compared to baseline, post-intervention surveys demonstrated significantly reduced distress (p = 0.01) and anxiety (p = 0.03); as well as increased non-reactivity (p<0.01), and feeling at peace (p<0.01). Post-intervention qualitative interviews, where 71% of participants reported benefit, were consistent with quantitative findings. In the interviews, participants spontaneously described reduced stress/anxiety and increased relaxation/calm. Benefits appeared to be accentuated in patient-caregiver pairs as compared to unpaired patients. Seventy-nine percent of participants reported plans for continued practice after study completion. We conclude that the Being Present audio-based mindfulness meditation program is of interest to, feasible, and acceptable for patients with metastatic colorectal cancer and caregivers, with initial evidence of efficacy. These results will guide plans for a follow-up study.

Trial registration: ClinicalTrials.gov NCT02423720.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Being Present participant flow diagram.

Summary of subject recruitment, retention, and data collected. Evaluable was defined by completion of any on-study assessment.

Fig 2. Graphic representations of survey scores at baseline and week 8.

N = 24. A) Box plots of National Comprehensive Cancer Network (NCCN) Distress Thermometer ratings: 0 = no distress; 10 = extreme distress. B) Box plots of National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Anxiety Short Form 4A scores. C) Box plots of Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) “Non-React” scores. D) Histograms of “Are You at Peace?" one-item spiritual probe ratings: 1 = not at all; 2 = a little bit; 3 = a moderate amount; 4 = quite a bit; 5 = completely. See Table 6 for P-values from paired t-tests.