Acceptance and commitment therapy for breast cancer survivors with fear of cancer recurrence: A 3-arm pilot randomized controlled trial.

BACKGROUND: Fear of cancer recurrence (FCR) has a profound negative impact on quality of life (QOL) for many cancer survivors. Breast cancer survivors (BCS) are particularly vulnerable, with up to 70% reporting clinically significant FCR. To the authors' knowledge, evidence-based interventions for managing FCR are limited. Acceptance and commitment therapy (ACT) promotes psychological flexibility in managing life's stressors. The current study examined the feasibility and preliminary efficacy of group-based ACT for FCR in BCS. METHODS: Post-treatment BCS (91 patients with stage I-III disease) with clinical FCR randomly were assigned to ACT (6 weekly 2-hour group sessions), survivorship education (SE; 6 weekly 2-hour group sessions), or enhanced usual care (EUC; one 30-minute group coaching session with survivorship readings). FCR severity (primary outcome) and avoidant coping, anxiety, post-traumatic stress, depression, QOL, and other FCR-related variables (secondary outcomes) were assessed at baseline (T1), after the intervention (T2), 1 month after the intervention (T3), and 6 months after the intervention (T4) using intent-to-treat analysis. RESULTS: Satisfactory recruitment (43.8%) and retention (94.5%) rates demonstrated feasibility. Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen d for effect sizes, 0.80; P < .001) and EUC (Cohen d, 0.61; P < .01). For 10 of 12 secondary outcomes, only ACT produced significant within-group reductions across all time points. By T4, significant moderate to large between-group comparisons favored ACT over SE and EUC with regard to avoidant coping, anxiety, depression, QOL, and FCR-related psychological distress. CONCLUSIONS: Group-based ACT is a feasible and promising treatment for FCR and associated outcomes in BCS that warrants testing in larger, fully powered trials.

Managing Chronic Pain in an Opioid Crisis: What Is the Role of Shared Decision-Making?

Shared decision-making (SDM) is a widely-advocated practice that has been linked to improved patient adherence, satisfaction, and clinical outcomes. SDM is a process in which patients and providers share information, express opinions, and build consensus toward a treatment decision. Chronic pain and its treatment present unique challenges for SDM, especially in the current environment in which opioids are viewed as harmful and a national opioid crisis has been declared. The purpose of this qualitative study is to understand treatment decision-making with patients taking opioids for chronic pain. Ninety-five clinic visits and 31 interviews with patients and primary care providers (PCPs) were analyzed using the constant comparison method. Results revealed that 1) PCPs desire patient participation in treatment decisions, but with caveats where opioids are concerned; 2) Disagreements about opioids, including perceptions of lack of listening, presented challenges to SDM; and 3) PCPs described engaging in persuasion or negotiation to convince patients to try alternatives to opioids, or appeasing patients requesting opioids with very small amounts in an effort to maintain the patient-provider relationship. Results are discussed through the lens of Charles, Gafni, and Whelan's SDM model, and implications of the role of the patient-provider relationship in SDM and chronic pain treatment are discussed.

Incorporating PROMIS Symptom Measures into Primary Care Practice-a Randomized Clinical Trial.

BACKGROUND: Symptoms account for more than 400 million clinic visits annually in the USA. The SPADE symptoms (sleep, pain, anxiety, depression, and low energy/fatigue) are particularly prevalent and undertreated. OBJECTIVE: To assess the effectiveness of providing PROMIS (Patient-Reported Outcome Measure Information System) symptom scores to clinicians on symptom outcomes. DESIGN: Randomized clinical trial conducted from March 2015 through May 2016 in general internal medicine and family practice clinics in an academic healthcare system. PARTICIPANTS: Primary care patients who screened positive for at least one SPADE symptom. INTERVENTIONS: After completing the PROMIS symptom measures electronically immediately prior to their visit, the 300 study participants were randomized to a feedback group in which their clinician received a visual display of symptom scores or a control group in which scores were not provided to clinicians. MAIN MEASURES: The primary outcome was the 3-month change in composite SPADE score. Secondary outcomes were individual symptom scores, symptom documentation in the clinic note, symptom-specific clinician actions, and patient satisfaction. KEY RESULTS: Most patients (84%) had multiple clinically significant (T-score ≥ 55) SPADE symptoms. Both groups demonstrated moderate symptom improvement with a non-significant trend favoring the feedback compared to control group (between-group difference in composite T-score improvement, 1.1; P = 0.17). Symptoms present at baseline resolved at 3-month follow-up only one third of the time, and patients frequently still desired treatment. Except for pain, clinically significant symptoms were documented less than half the time. Neither symptom documentation, symptom-specific clinician actions, nor patient satisfaction differed between treatment arms. Predictors of greater symptom improvement included female sex, black race, fewer medical conditions, and receiving care in a family medicine clinic. CONCLUSIONS: Simple feedback of symptom scores to primary care clinicians in the absence of additional systems support or incentives is not superior to usual care in improving symptom outcomes. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02383862.

A qualitative study of patients' perceptions of the utility of patient-reported outcome measures of symptoms in primary care clinics.

PURPOSE: Sleep, pain, anxiety, depression, and low energy/fatigue (SPADE pentad) symptoms are common, but often unrecognized and undertreated in primary care. In an effort to improve symptom outcomes, primary care clinics are integrating patient-reported outcome measures (PROs), such as the Patient-Reported Outcome Measurement Information System (PROMIS), into practice. Whether patients with SPADE symptoms perceive these measures as useful is unknown. The purpose of this qualitative study was to explore patients' perceptions of the utility of symptom-based PROs in primary care. METHODS: As part of a mixed-methods study, 23 patients (age 24-77 years) with one or more SPADE symptoms participated in one-on-one interviews about the use, implementation and visual display of PROMIS. All interviews were audio-recorded, transcribed, and analyzed using thematic analysis. RESULTS: Five themes emerged: (1) PROs may foster communication about symptoms; (2) data from PROs may prompt clinical actions; (3) the visual display of symptom scores could be useful for patients and providers, though modifications may enhance interpretation; (4) implementation may vary according to patients' perception of PRO features (e.g., length); and (5) PROs may be useful, but only to the extent that they are valued, prioritized, and used. CONCLUSIONS: According to patients, the use of PROs to measure symptoms in primary care clinics has the potential to be useful. However, patients are reluctant to complete PROs if they perceive that clinicians do not use the measures to improve care. Barriers to implementation in primary care (e.g., duration of visit) should be addressed to enhance the utility of PROs. Clinical trial registration ClinicalTrials.gov ID: NCT02383862.

Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.

PURPOSE: Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms. METHODS: Breast (n = 60) and colorectal (n = 11) cancer survivors (stage 0-III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis. RESULTS: Between-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d = -0.46, p = 0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d = 0.53, p = 0.003) and were more likely to report CRF as moderately to completely improved compared to the PES group (χ2 (1) = 4.1765, p = 0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d = 0.53, p = 0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1. CONCLUSION: MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01724333.

Effects of mindfulness-based interventions on fatigue in cancer survivors: A systematic review and meta-analysis of randomized controlled trials.

This systematic review and meta-analysis was designed to determine the efficacy of mindfulness-based interventions (MBIs) in improving fatigue-related outcomes in adult cancer survivors. Randomized controlled trials (RCTs) were identified from PubMed, MEDLINE, PsycINFO, CINAHL, Web of Science, and EMBASE databases and reference lists of included studies. Separate random-effects meta-analyses were conducted for fatigue and vitality/vigor. Twenty-three studies reporting on 21 RCTs (N = 2239) met inclusion criteria. MBIs significantly reduced fatigue compared to controls at post-intervention (g = 0.60, 95 % CI [0.36, 0.83]) and first follow-up (g = 0.42, 95 % CI [0.20, 0.64]). Likewise, MBIs significantly improved vitality/vigor at post-intervention (g = 0.39, 95 % CI [0.25, 0.52]) and first follow-up (g = 0.35, 95 % CI [0.03, 0.67]). The evidence grade was low due to risk of bias, substantial heterogeneity, and publication bias among studies. MBIs show promise in improving fatigue and vitality/vigor in cancer survivors. More rigorous trials are needed to address current gaps in the evidence base.

Mindfulness Training Supports Quality of Life and Advance Care Planning in Adults With Metastatic Cancer and Their Caregivers: Results of a Pilot Study.

BACKGROUND: Emotional distress often causes patients with cancer and their family caregivers (FCGs) to avoid end-of-life discussions and advance care planning (ACP), which may undermine quality of life (QoL). Most ACP interventions fail to address emotional barriers that impede timely ACP. AIM: We assessed feasibility, acceptability, and preliminary effects of a mindfulness-based intervention to facilitate ACP for adults with advanced-stage cancer and their FCGs. DESIGN: A single-arm pilot was conducted to assess the impact of a 6-week group mindfulness intervention on ACP behaviors (patients only), QoL, family communication, avoidant coping, distress, and other outcomes from baseline (T1) to post-intervention (T2) and 1 month later (T3). PARTICIPANTS: Eligible patients had advanced-stage solid malignancies, limited ACP engagement, and an FCG willing to participate. Thirteen dyads (N = 26 participants) enrolled at an academic cancer center in the United States. RESULTS: Of eligible patients, 59.1% enrolled. Attendance (70.8% across 6 sessions) and retention (84.6% for patients; 92.3% for FCGs) through T3 were acceptable. Over 90% of completers reported high intervention satisfaction. From T1 to T3, patient engagement more than doubled in each of 3 ACP behaviors assessed. Patients reported large significant decreases in distress at T2 and T3. Family caregivers reported large significant improvements in QoL and family communication at T2 and T3. Both patients and FCGs reported notable reductions in sleep disturbance and avoidant coping at T3. CONCLUSIONS: The mindfulness intervention was feasible and acceptable and supported improvements in ACP and associated outcomes for patients and FCGs. A randomized trial of mindfulness training for ACP is warranted. The study is registered at ClinicalTrials.gov with identifier NCT02367508 ( https://clinicaltrials.gov/ct2/show/NCT02367508 ).

PROMIS 4-item measures and numeric rating scales efficiently assess SPADE symptoms compared with legacy measures.

OBJECTIVE: The 5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms are among the most prevalent and disabling symptoms in clinical practice. This study evaluates the minimally important difference (MID) of Patient-Reported Outcomes Measurement Information System (PROMIS) measures and their correspondence with other brief measures to assess SPADE symptoms. STUDY DESIGN AND SETTING: Three hundred primary care patients completed a 4-item PROMIS scale, a numeric rating scale (NRS), and a non-PROMIS legacy scale for each of the 5 SPADE symptoms. Optimal NRS cutpoints were examined, and cross-walk units for converting legacy measure scores to PROMIS scores were determined. PROMIS scores corresponding to standard deviation (SD) and standard error of measurement (SEM) changes in legacy scores were used to estimate MID. RESULTS: At an NRS ≥5, the mean PROMIS T-score exceeded 55 (the operational threshold for a clinically meaningful symptom) for each SPADE symptom. Correlations were high (0.70-0.86) between each PROMIS scale and its corresponding non-PROMIS legacy scale. Changes in non-PROMIS legacy scale scores of 0.35 SD and 1 SEM corresponded to mean PROMIS T-scores of 2.92 and 3.05 across the 5 SPADE symptoms, with changes in 0.2 and 0.5 SD corresponding to mean PROMIS T-scores of 1.67 and 4.16. CONCLUSION: A 2-step screening process for SPADE symptoms might use single-item NRS scores, proceeding to PROMIS scales for NRS scores ≥5. A PROMIS T-score change of three points represents a reasonable MID estimate, with two to four points approximating lower and upper bounds.

Neuropsychologic outcomes in a case series of twins discordant for perinatal stroke.

Perinatal stroke may affect cognitive development, but few studies have addressed the details of cognitive function after perinatal stroke. The present study was designed to compare the neuropsychologic features of five sets of twins discordant for perinatal stroke. All of the affected children had unilateral middle cerebral artery infarction (two left, three right); four of the five infarcts were large-branch, affecting the entire M1 territory. Three of the five affected children had comorbid epilepsy. Measures of intelligence, memory, language, attention, executive function, visual-motor integration, and fine motor skills were administered to children at a median age of 5 years (range, 5-8 years). Relative to their unaffected co-twins, the twins with perinatal stroke exhibited lower levels of full scale (p=0.005), verbal (p=0.006), and nonverbal (p=0.005) intelligence. Children with perinatal stroke also showed significant deficits on tests of verbal memory (p=0.041), receptive language (p=0.011), verbal fluency (p=0.019), and visual attention (p=0.011), compared with their unaffected co-twins. Twin gestation may be a risk factor for poor cognitive outcome after perinatal stroke. Large infarct size and comorbid epilepsy may have contributed to some of the poor cognitive outcomes in this cohort.

Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: effects on cancer-related cognitive impairment.

PURPOSE: Cancer-related cognitive impairment (CRCI) is a common, fatigue-related symptom that disrupts cancer survivors' quality of life. Few interventions for CRCI exist. As part of a randomized pilot study targeting cancer-related fatigue, the effects of mindfulness-based stress reduction (MBSR) on survivors' cognitive outcomes were investigated. METHODS: Breast and colorectal cancer survivors (n = 71) with moderate-to-severe fatigue were randomized to MBSR (n = 35) or a fatigue education and support (ES; n = 36) condition. The Attentional Function Index (AFI) and the Stroop test were used to assess survivors' cognitive function at baseline (T1), after the 8-week intervention period (T2), and 6 months later (T3) using intent-to-treat analysis. Mediation analyses were performed to explore mechanisms of intervention effects on cognitive functioning. RESULTS: MBSR participants reported significantly greater improvement on the AFI total score compared to ES participants at T2 (d = 0.83, p = 0.001) and T3 (d = 0.55, p = 0.021). MBSR also significantly outperformed ES on most AFI subscales, although both groups improved over time. MBSR produced greater Stroop accuracy rates relative to ES at T2 (r = 0.340, p = 0.005) and T3 (r = 0.280, p = 0.030), with improved accuracy over time only for the MBSR group. There were no significant differences in Stroop reaction time between groups. Improvements in mindfulness mediated the effect of group (e.g., MBSR vs. ES) on AFI total score at T2 and T3. CONCLUSIONS: Additional randomized trials with more comprehensive cognitive measures are warranted to definitively assess the efficacy of MBSR for CRCI. IMPLICATIONS FOR CANCER SURVIVORS: This pilot study has important implications for all cancer survivors as it is the first published trial to show that MBSR offers robust and durable improvements in CRCI.