Low RNA disruption during neoadjuvant chemotherapy predicts pathologic complete response absence in patients with breast cancer.

In previously reported retrospective studies, high tumor RNA disruption during neoadjuvant chemotherapy predicted for post-treatment pathologic complete response (pCR) and improved disease-free survival at definitive surgery for primary early breast cancer. The BREVITY (Breast Cancer Response Evaluation for Individualized Therapy) prospective clinical trial (NCT03524430) seeks to validate these prior findings. Here we report training set (Phase I) findings, including determination of RNA disruption index (RDI) cut points for outcome prediction in the subsequent validation set (Phase II; 454 patients). In 80 patients of the training set, maximum tumor RDI values for biopsies obtained during neoadjuvant chemotherapy were significantly higher in pCR responders than in patients without pCR post-treatment (P = .008). Moreover, maximum tumor RDI values ≤3.7 during treatment predicted for a lack of pCR at surgery (negative predictive value = 93.3%). These findings support the prospect that on-treatment tumor RNA disruption assessments may effectively predict post-surgery outcome, possibly permitting treatment optimization.

Impact of a Training Program on Oncology Nurses' Confidence in the Provision of Self-Management Support and 5As Behavioral Counseling Skills.

BACKGROUND: Cancer patients and their families play a central role in the self-management of the medical, emotional, and lifestyle consequences of cancer. Nurses with training in self-management support can enable cancer patients to better manage the effects of cancer and treatment. METHODS: As part of a randomized controlled trial, we developed a training program to build nurses' confidence in the provision of self-management support (SMS). The SMS skills taught were adapted from the Stanford Peer Support training programs and embedded within the 5As (Assess, Advise, Agree, Assist, and Arrange) behavioral counseling process. We evaluated the impact of the training program on oncology nurses' and coaches' confidence using a Student's t-test for paired samples in a nonrandomized, one-group pre/postsurvey. RESULTS: Participants were experienced oncology nurses from three participating cancer centers. A two-tailed Student's t-test for paired samples showed a significant improvement in nurses' confidence for the 15 SMS microskills targeted in the training between the pretest and post-test as follows: for Center 1, a mean difference of 0.79 (t = 7.18, p ≤ 0.00001); for Center 2, a mean difference of 0.73 (t = 8.4, p ≤ 0.00001); for Center 3, a mean difference of 1.57 (t = 11.45, p ≤ 0.00001); and for coaches, a mean difference of 0.52 (t = 7.6, p ≤ 0.00001). CONCLUSIONS: Our training program improved oncology staff nurses' and cancer coaches' confidence in 15 SMS microskills and has potential for SMS training of nurses in routine care.

Feasibility and Effectiveness of Self-Management Education and Coaching on Patient Activation for Managing Cancer Treatment Toxicities.

BACKGROUND: Poorly managed cancer treatment toxicities negatively impact quality of life, but little research has examined patient activation in self-management (SM) early in cancer treatment. METHODS: We undertook a pilot randomized trial to evaluate the feasibility, acceptability, and preliminary effectiveness of the SMARTCare (Self-Management and Activation to Reduce Treatment Toxicities) intervention. This intervention included an online SM education program (I-Can Manage) plus 5 sessions of telephone cancer coaching in patients initiating systemic therapy for lymphoma or colorectal or lung cancer at 3 centers in Ontario, Canada, relative to a usual care control group. Patient-reported outcomes included patient activation (Patient Activation Measure [PAM]), symptom or emotional distress, self-efficacy, and quality of life. Descriptive statistics and Wilcoxon rank-sum tests were used to examine changes over time (baseline and at 2, 4, and 6 months) within and between groups. We used general estimating equations to compare outcomes between groups over time. The intervention group completed an acceptability survey and qualitative interviews. RESULTS: Of 90 patients approached, 62 (68.9%) were enrolled. Mean age of the sample was 60.5 years. Most patients were married (77.1%), were university educated (71%), had colorectal cancer (41.9%) or lymphoma (42.0%), and had stage III or IV disease (75.8%). Attrition was higher in the intervention group than among control subjects (36.7% vs 25%, respectively). Adherence to I-Can Manage was low; 30% of intervention patients completed all 5 coaching calls, but 87% completed ≥1. Both the continuous PAM total score (P<.001) and categorical PAM levels (3/4 vs 1/2) (P=.002) were significantly improved in the intervention group. CONCLUSIONS: SM education and coaching early during cancer treatment may improve patient activation, but a larger trial is needed. CLINICALTRIALS: gov Identifier: NCT03849950.

Improving the quality of self-management support in ambulatory cancer care: a mixed-method study of organisational and clinician readiness, barriers and enablers for tailoring of implementation strategies to multisites.

INTRODUCTION: Improving the quality of self-management support (SMS) for treatment-related toxicities is a priority in cancer care. Successful implementation of SMS programmes depends on tailoring implementation strategies to organisational readiness factors and barriers/enablers, however, a systematic process for this is lacking. In this formative phase of our implementation-effectiveness trial, Self-Management and Activation to Reduce Treatment-Related Toxicities, we evaluated readiness based on constructs in the Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT) and developed a process for mapping implementation strategies to local contexts. METHODS: In this convergent mixed-method study, surveys and interviews were used to assess readiness and barriers/enablers for SMS among stakeholders in 3 disease site groups at 3 regional cancer centres (RCCs) in Ontario, Canada. Median survey responses were classified as a barrier, enabler or neutral based on a priori cut-off values. Barriers/enablers at each centre were mapped to CFIR and then inputted into the CFIR-Expert Recommendations for Implementing Change Strategy Matching Tool V.1.0 (CFIR-ERIC) to identify centre-specific implementation strategies. Qualitative data were separately analysed and themes mapped to CFIR constructs to provide a deeper understanding of barriers/enablers. RESULTS: SMS in most of the RCCs was not systematically delivered, yet most stakeholders (n=78; respondent rate=50%) valued SMS. For centre 1, 7 barriers/12 enablers were identified, 14 barriers/9 enablers for centre 2 and 11 barriers/5 enablers for centre 3. Of the total 46 strategies identified, 30 (65%) were common across centres as core implementation strategies and 5 tailored implementation recommendations were identified for centres 1 and 3, and 4 for centre 2. CONCLUSIONS: The CFIR and CFIR-ERIC were valuable tools for tailoring SMS implementation to readiness and barriers/enablers, whereas NPT helped to clarify the clinical work of implementation. Our approach to tailoring of implementation strategies may have relevance for other studies.

Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial.

OBJECTIVE: To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer. DESIGN: Pragmatic, cluster randomised trial. SETTING: 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care. PARTICIPANTS: All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires. INTERVENTIONS: Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle. MAIN OUTCOME MEASURES: The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life. RESULTS: Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively. CONCLUSIONS: Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant. TRIAL REGISTRATION: ClinicalTrials.gov NCT02485678.

Utility of the Edmonton Frail Scale in identifying frail elderly patients during treatment of colorectal cancer.

BACKGROUND: Frailty has been proposed by geriatricians as an indicator of functional age. The Edmonton Frail Scale (EFS) is a 15-point incremental scale; it is quick (<5 min), and simple to administer. We conducted an exploratory study to establish if the EFS add utility to clinician's expertise by determining if there was an association between EFS and receipt of chemotherapy in colorectal cancer (CRC) patients. METHODS: The EFS was administered to stage II-IV CRC patients ≥70 years. EFS assessment was completed by one of the investigators, with the treating oncology team blinded to the results. RESULTS: A total of 46 patients were enrolled, and the EFS was reproduced in 32 patients at two visits (r=0.81; 95% CI: 0.64-0.90, P<0.0001). There was no correlation between the EFS and receipt of chemotherapy for the study population as a whole; however, exclusion of stage II patients showed a reduced likelihood of receiving chemotherapy with higher EFS scores (odds ratio 0.56; 95% CI: 0.37-0.85, P<0.01 per unit increment). A similar effect was observed after multivariable analysis (adjusting for performance status, age, stage and gender, odds ratio 0.41 95% CI: 0.18-0.96, P<0.05 per unit increment). CONCLUSIONS: This exploratory study suggests that EFS can identify patients that oncologists may have thought were too frail for chemotherapy, independent of PS. Therefore, the EFS has the potential to add a reproducible, and quantifiable measure of frailty to the clinician's decision making toolset. A follow up study will employ the EFS in real-time, and determine if using the EFS can minimize complications and unplanned health care utilization in elderly cancer patients.