Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial.

>276,000 Americans will be diagnosed with invasive breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ this year and most will undergo breast surgery as part of their care. Although prognosis is excellent, many patients experience persistent post-surgical pain (PSP), which has no satisfactory pharmacological treatment. The causal contributions of pain-associated psychological factors (e.g., catastrophic thoughts about pain, psychological flexibility, self-efficacy) to the continuing burden of PSP have not yet been determined and may be opportune intervention targets. The randomized trial described here will compare the benefits of three manualized behavioral interventions for individuals with PSP. Participants will receive either: 1) self-guided health education (SGHE); 2) interventionist-guided health education (IGHE); or 3) interventionist-guided pain coping skills training with elements of acceptance and commitment therapy that specially target catastrophic thoughts about pain, self-efficacy, and psychological flexibility (CST-PSP). Participants will prospectively complete validated assessments of primary outcomes (PSP severity and interference) at baseline (pre-intervention) and 3-, 6-, and 12-months later. Validated measures of emotional distress and cancer-specific distress will be assessed as secondary outcomes. To test their roles as drivers of PSP, catastrophic thoughts about pain, self-efficacy, and psychological flexibility, will be assessed and statistically analyzed as mediators of hypothesized beneficial effects. The interventions' impacts on pain sensitivity and central sensitization will be investigated to test these physiological pathways as proximal drivers of PSP. To better characterize the patient experience, additional validated measures will be explored for associations with PSP, along with demographic and clinical factors. Trial registration: https://clinicaltrials.gov/ct2/show/NCT04225585, registered January 13, 2020.

Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial.

BACKGROUND: As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. METHODS/DESIGN: The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. DISCUSSION: As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. TRIAL REGISTRATION: This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP).

PURPOSE: Cancer survivors are often sedentary. Self-monitoring may promote physical activity through self-activation. We conducted a pilot trial to evaluate whether wearable activity tracker with personalized text message feedback would increase physical activity. METHODS: We enrolled 30 patients with solid tumor cancers into a non-randomized prospective intervention trial (NCT02627079): 15 had completed treatment in the past year and 15 under active treatment. Each participant received an activity tracker and daily text messages personalized to their activity level. We assessed patient-reported outcomes and 6-min walk (6 MW) at baseline and 3 months. RESULTS: Twenty-six participants completed the study. There was substantial variation in baseline activity. Overall, 39% of participants increased their steps taken by at least 20%, and 23% increased their 6 MW distance by 20% or more. More participants who had completed treatment strongly agreed (73%) that the intervention increased their exercise levels than those receiving active treatment (47%). At 3 months, there was a significant improvement in median Beck Depression Inventory-II and Godin Leisure Index composite scores. At 6 months, 72% still wore their activity tracker at least 4 days per week. CONCLUSION: We found that the intervention was well-accepted with a high completion rate at 3 months and continued self-use at 6 months. In this pilot study of combined activity tracker and motivational messaging, we found a signal for increased physical activity over a 3-month period. Future research is needed to study this technique for its impact on activity and other physical and psychological measures of well-being. IMPLICATION FOR CANCER SURVIVORS: Activity tracker with personalized motivational messaging may be useful in promoting physical activity in cancer survivors.

Improving health engagement and lifestyle management for breast cancer survivors with diabetes.

Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov, NCT02970344, registered 11/22/2016.

Coping Skills Training and Acceptance and Commitment Therapy for Symptom Management: Feasibility and Acceptability of a Brief Telephone-Delivered Protocol for Patients With Advanced Cancer.

CONTEXT: Patients with advanced cancer face a life-limiting condition that brings a high symptom burden that often includes pain, fatigue, and psychological distress. Psychosocial interventions have promise for managing symptoms but need additional tailoring for these patients' specific needs. Patients with advanced cancer in the community also face persistent barriers-availability of interventions in community clinics as well as financial and illness-related factors-to accessing psychosocial interventions. OBJECTIVES: The aim of the present study was to assess the feasibility and acceptability of telephone implementation of Engage, a novel brief combined Coping Skills Training and Acceptance and Commitment Therapy protocol, for reducing symptoms and increasing quality of life in community patients with advanced cancer. METHODS: Adult patients with advanced cancer receiving care in the community received Engage, four 60-minute manualized telephone sessions delivered by a trained psychotherapist and completed pretreatment and post-treatment assessments. RESULTS: Engage was feasible, achieving 100% accrual (N = 24) of a heterogeneous sample of patients with advanced cancer, with good retention (88% completed). Acceptability was demonstrated via satisfaction (mean 29 of 32; SD 2), engagement (95% attendance), and use of skills. Secondary analyses pointed to reductions in pain interference, fatigue, psychological distress, and improvements in psychological acceptance and engagement in value-guided activity after treatment. CONCLUSION: Engage, our brief novel combined Coping Skills and Acceptance and Commitment Therapy intervention, demonstrated initial feasibility and acceptability when delivered over the telephone and increased access for community clinic patients with advanced cancer. Future research will assess the comparative efficacy of Engage in larger randomized trials.

Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).

Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). Adherence to AET will be assessed in real-time for 18 months using wireless smart pill bottles. Symptom interference (i.e., pain, vasomotor symptoms, sleep problems, vaginal dryness) and cost-effectiveness of the intervention protocol will be examined as secondary outcomes. Participants (N = 400) will be recruited from a tertiary care medical center or community clinics in medically underserved or rural areas. Participants will be randomized to receive CST-AET or a general health education intervention (comparison condition). CST-AET includes ten nurse-delivered calls delivered over 6 months. CST-AET provides systematic training in coping skills for managing symptoms that interfere with adherence. Interactive voice messaging provides reinforcement for skills use and adherence that is tailored based on real-time adherence data from the wireless smart pill bottles. Given the high rates of non-adherence and recent recommendations that women remain on AET for 10 years, we describe a timely trial. If effective, the CST-AET protocol may not only reduce the burden of AET use but also lead to cost-effective changes in clinical care and improve breast cancer outcomes. Trials registration: ClinicalTrials.gov, NCT02707471, registered 3/3/2016.

Using a geriatric oncology assessment to link with services (GOAL).

OBJECTIVE: Geriatric screening tools assess functional limitations and inform clinical decision-making for older adults with cancer. Our objective was to evaluate the feasibility and effectiveness of a screener in community-based oncology clinics. MATERIALS AND METHODS: Eligible patients were from two rural, underserved community-based cancer clinics; within 12 months of a cancer diagnosis (breast, lung, colorectal, pancreas, esophageal); aged ≥60 years; and not exclusively pursuing palliative care. We used a previously validated tool that was embedded in the electronic health record (EHR). Patient-reported responses identified memory impairment, depressive symptoms, deficits in activities of daily living, poor nutrition, and polypharmacy. At the discretion of the oncologist, responses prompted service referrals. From the EHR, we extracted information about referrals and completion of planned therapy. We present descriptive statistics. RESULTS: Enrolled patients (n = 44) had a mean age of 71.5 years (SD = 6.9). Most were non-white (61%), women (66%), with government-sponsored health insurance (80%). The most commonly identified geriatric syndromes: polypharmacy (89%), reduced quality of life (39%), and poor nutrition (39%). The screener triggered a referral in 98% of patients. Generated referrals were for depressive symptoms (52% needed, 39% received), nutrition (43% needed, 37% received), and polypharmacy (89% needed, 26% received). Patients were referred to social work (56%), nutrition (44%), and pharmacy (25%). Many patients completed planned radiation therapy (100%), surgery (70%), and chemotherapy (60%). CONCLUSIONS: Use of an EHR-embedded brief geriatric oncology assessment in rural oncology clinics identified geriatric syndromes that would benefit from provision of services in nearly all enrolled patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02906592.

A smoking cessation and pain management program for cancer survivors.

PURPOSE: Many cancer survivors continue to smoke. Further, most survivors also report high levels of persistent pain and smoke in response to pain. The investigators tested the feasibility, acceptability, and preliminary efficacy of a smoking cessation program paired with a pain management program for cancer survivors. METHODS: The investigators conducted a two-arm, wait-list randomized controlled pilot study in which they delivered a combined smoking cessation and pain management intervention. RESULTS: The investigators randomized 30 survivors (14 intervention and 16 wait-list control). Seventy-one percent of the survivors who received the intervention rated it as extremely useful (5 out of 5) in helping them quit smoking. Further, 86% would recommend the program to other survivors. Although we could not conduct inferential statistics, 14% of those in the intervention arm, compared to 6% in the control condition had biochemically validated cessation at 2-months post-randomization. Survivors in the intervention also reported less pain, had improvements in depressive symptoms, and better physical function than those in the control arm. CONCLUSIONS: Our pilot data suggest the feasibility, acceptability, and preliminary efficacy of this approach. The next step is to conduct a large randomized controlled trial to fully test the efficacy of the intervention. IMPLICATIONS FOR CANCER SURVIVORS: A combined smoking cessation and pain program might help improve both issues simultaneously.

Comparison of self-reported and measured height and weight in eighth-grade students.

The goal of this study was to evaluate the relationships between self-reported and measured height, weight, and body mass index (BMI) in a sample of eighth-grade students. The study population consisted of eighth-grade students in eastern North Carolina who completed a cross-sectional survey, self-reported their height and weight, and had their height and weight measured (N = 416). Fifty-nine percent of the sample was male; 42% African American, 46% white, and 12% other races. Mean self-reported weight (62.9 kg) was significantly lower than mean measured weight (64.4 kg). Mean self-reported BMI (22.8 kg/m2) was significantly lower than mean measured BMI (23.3 kg/m2). Race and BMI category were significantly associated with reporting errors. Specifically, African American and white students were significantly less likely to under-report their height compared to other race students. African American students were more likely to underestimate their weight compared to other race students. BMI was more likely to be underestimated in African American and white students compared to other race students. Students who were at risk for overweight and those that were overweight were more likely to underestimate their weight and BMI than students who were normal weight. Approximately 17% of students were misclassified in BMI categories when self-reported data were used. The results indicate that eighth-grade students significantly underestimate their weight, but on average provide valid estimates of their height. Race and measured BMI category influence this discrepancy. School-based research that addresses the prevalence of obesity in adolescents should utilize measured height and weight when feasible.