Managing Chronic Pain in Cancer Survivorship: Communication Challenges and Opportunities as Described by Cancer Survivors.

OBJECTIVES: Many cancer survivors experience chronic pain after completing curative-intent treatment. Based on available data, chronic pain may be undertreated in this context; however, little is known about cancer survivors' experiences with clinical management of chronic pain. The purpose of this study was to better understand cancer survivors' pain management experiences after curative-intent treatment. METHODS: We conducted 13 semi-structured interviews with a convenience sample of cancer survivors who had completed treatment for stage I-III breast, head/neck, lung or colorectal cancer. We used a thematic approach to qualitative data analysis. RESULTS: Participants described that chronic pain often goes unrecognized by their providers, potentially due to limitations in how pain is assessed clinically and the tendency of both cancer survivors and providers to minimize or invalidate the pain experience. To improve communication, participants suggested that providers ask more open-ended questions about their pain, help them to establish functional goals, and provide patients with options for pain management. SIGNIFICANCE OF RESULTS: This study demonstrates the importance of provider-initiated communication around pain management for cancer survivors to make them feel more supported in their care. Communication and shared decision-making interventions may improve cancer survivor-provider communication around chronic pain management, addressing an important gap in survivorship care.

Describing current use, barriers, and facilitators of patient portal messaging for research recruitment: Perspectives from study teams and patients at one institution.

Introduction: The electronic health record (EHR) and patient portal are used increasingly for clinical research, including patient portal recruitment messaging (PPRM). Use of PPRM has grown rapidly; however, best practices are still developing. In this study, we examined the use of PPRM at our institution and conducted qualitative interviews among study teams and patients to understand experiences and preferences for PPRM. Methods: We identified study teams that sent PPRMs and patients that received PPRMs in a 60-day period. We characterized these studies and patients, in addition to the patients' interactions with the PPRMs (e.g., viewed, responded). From these groups, we recruited study team members and patients for semi-structured interviews. A pragmatic qualitative inquiry framework was used by interviewers. Interviews were audio-recorded and analyzed using a rapid qualitative analysis exploratory approach. Results: Across ten studies, 35,037 PPRMs were sent, 33% were viewed, and 17% were responded to. Interaction rates varied across demographic groups. Six study team members completed interviews and described PPRM as an efficient and helpful recruitment method. Twenty-eight patients completed interviews. They were supportive of receiving PPRMs, particularly when the PPRM was relevant to their health. Patients indicated that providing more information in the PPRM would be helpful, in addition to options to set personalized preferences. Conclusions: PPRM is an efficient recruitment method for study teams and is acceptable to patients. Engagement with PPRMs varies across demographic groups, which should be considered during recruitment planning. Additional research is needed to evaluate and implement recommended changes by study teams and patients.

Using the Consolidated Framework for Implementation Research to Inform the Design of the Mobile Inspección Visual con Ácido Acético System: Mixed Methods Case Study.

BACKGROUND: There is growing evidence supporting the use of mobile health (mHealth) interventions in low- and middle-income countries to address resource limitations in the delivery of health information and services to vulnerable populations. In parallel, there is an increasing emphasis on the use of implementation science tools and frameworks for the early identification of implementation barriers and to improve the acceptability, appropriateness, and adoption of mHealth interventions in resource-limited settings. However, there are limited examples of the application of implementation science tools and frameworks to the formative phase of mHealth design for resource-limited settings despite the potential benefits of this work for enhancing subsequent implementation, scale-up, and sustainability. OBJECTIVE: We presented a case study on the use of an implementation science framework in mHealth design. In particular, we illustrated the usability of the Consolidated Framework for Implementation Research (CFIR) for organizing and interpreting formative research findings during the design of the mobile Inspección Visual con Ácido Acético (mIVAA) system in Lima, Peru. METHODS: We collected formative data from prospective users of the mIVAA intervention using multiple research methodologies, including structured observations, surveys, group and individual interviews, and discussions with local stakeholders at the partnering organization in Peru. These activities enabled the documentation of clinical workflows, perceived barriers to and facilitators of mIVAA, overarching barriers to cervical cancer screening in community-based settings, and related local policies and guidelines in health care. Using a convergent mixed methods analytic approach and the CFIR as an organizing framework, we mapped formative research findings to identify key implementation barriers and inform iterations of the mIVAA system design. RESULTS: In the setting of our case study, most implementation barriers were identified in the CFIR domains of intervention characteristics and inner setting. All but one barrier were addressed before mIVAA deployment by modifying the system design and adding supportive resources. Solutions involved improvements to infrastructure, including cellular data plans to avoid disruption from internet failure; improved process and flow, including an updated software interface; and better user role definition for image capture to be consistent with local health care laws. CONCLUSIONS: The CFIR can serve as a comprehensive framework for organizing formative research data and identifying key implementation barriers during mHealth intervention design. In our case study of the mIVAA system in Peru, formative research contributing to the CFIR domains of intervention characteristics and inner setting elicited the most key barriers to implementation. The early identification of barriers enabled design iterations before system deployment. Future efforts to develop mHealth interventions for low- and middle-income countries may benefit from using the approach presented in this case study as well as prioritizing the CFIR domains of intervention characteristics and inner setting.

Why do patients with chronic hepatitis C drink alcohol? An examination of pain, depression and drinking motives.

Alcohol consumption in the setting of chronic HCV is associated with accelerated progression towards cirrhosis, increased risk of hepatocellular carcinoma and higher mortality. This analysis contextualizes how sociodemographic factors, chronic pain and depression relate to the motivations of individuals with chronic HCV to consume alcohol. We conducted a secondary analysis of baseline data from the Hep ART trial of behavioural interventions on alcohol use among patients with HCV. Alcohol consumption was measured using the Drinking Motives Questionnaire and a novel 6-item measure of pain-related drinking motives. Statistical analyses performed included ANOVA for bivariate analyses and multivariable ordinary least-squares linear regression. At study baseline, 181 participants had an average age of 55 years; the majority (66.7%) reported beyond-minor pain; and a third (37%) met criteria for depression; drinking motives were higher for individuals with beyond-minor pain (means 9.9 vs. 4.6, p < .001) and who met criteria for depression (means 10.9 vs. 6.4, p < .001) when using the pain-related drinking motives items. Average pain(coef = 1.0410067141 < .001) was significantly associated with increased motives to drink to relieve pain in the full baseline model specification controlling for all covariates using ordinary at least squares; depression (coef = 7.06; 95% CI 1.32, 12.81; p = .016) was significantly associated with increased non-pain-related motives to drink. From baseline to 3-month follow-up, compared to participants who had mean average pain scores among the sample, motives to drink to relieve pain decreased in participants who had higher average pain scores (coef = -0.30; 95% CI -0.59, -0.01; p = .40). Physical pain and depression are associated with increased motives to consume alcohol. Patients with chronic liver disease should be screened for chronic pain and depression and, if present, referred to pain specialists or co-managed in partnership with pain specialists in hepatology clinics.

Barriers to the uptake of cervical cancer services and attitudes towards adopting new interventions in Peru.

Cervical cancer mortality is high among Peruvian women of reproductive age. Understanding barriers and facilitators of cervical cancer screening and treatment could facilitate development of contextually-relevant interventions to reduce cervical cancer incidence and mortality. From April to October 2019, we conducted a cross-sectional survey with 22 medical personnel and administrative staff from Liga Contra el Cancer, in Lima, Peru. The survey included structured and open-ended questions about participants' roles in cervical cancer prevention and treatment, perceptions of women's barriers and facilitators for getting screened and/or treated for cervical cancer, as well as attitudes towards adopting new cervical cancer interventions. For structured questions, the frequency of responses for each question was calculated. For responses to open-ended questions, content analysis was used to summarize common themes. Our data suggest that the relative importance and nature of barriers that Peruvian women face are different for cervical cancer screening compared to treatment. In particular, participants mentioned financial concerns as the primary barrier to treatment and a lack of knowledge or awareness of human papillomavirus and/or cervical cancer as the primary barrier to screening uptake among women. Participants reported high willingness to adopt new interventions or strategies related to cervical cancer. Building greater awareness about benefits of cervical cancer screening among women, and reducing financial and geographic barriers to treatment may help improve screening rates, decrease late-stage diagnosis and reduce mortality in women who have a pre-cancer diagnosis, respectively. Further studies are needed to generalize study findings to settings other than Lima, Peru.

Using digital health to facilitate compliance with standardized pediatric cancer treatment guidelines in Tanzania: protocol for an early-stage effectiveness-implementation hybrid study.

BACKGROUND: In high-income countries (HICs), increased rates of survival among pediatric cancer patients are achieved through the use of protocol-driven treatment. Compared to HICs, differences in infrastructure, supportive care, and human resources, make compliance with protocol-driven treatment challenging in low- and middle-income countries (LMICs). For successful implementation of protocol-driven treatment, treatment protocols must be resource-adapted for the LMIC context, and additional supportive tools must be developed to promote protocol compliance. In Tanzania, an LMIC where resource-adapted treatment protocols are available, digital health applications could promote protocol compliance through incorporation of systematic decision support algorithms, reminders and alerts related to patient visits, and up-to-date data for care coordination. However, evidence on the use of digital health applications in improving compliance with protocol-driven treatment for pediatric cancer is limited. This study protocol describes the development and evaluation of a digital health application, called mNavigator, to facilitate compliance with protocol-driven treatment for pediatric cancer in Tanzania. METHODS: mNavigator is a digital case management system that incorporates nationally-approved and resource-adapted treatment protocols for two pediatric cancers in Tanzania, Burkitt lymphoma and retinoblastoma. mNavigator is developed from an open-source digital health platform, called CommCare, and guided by the Consolidated Framework for Implementation Research. From July 2019-July 2020 at Bugando Medical Centre in Mwanza, Tanzania, all new pediatric cancer patients will be registered and managed using mNavigator as the new standard of care for patient intake and outcome assessment. Pediatric cancer patients with a clinical diagnosis of Burkitt lymphoma or retinoblastoma will be approached for participation in the study evaluating mNavigator. mNavigator users will document pre-treatment and treatment details for study participants using digital forms and checklists that facilitate compliance with protocol-driven treatment. Compliance with treatment protocols using mNavigator will be compared to historical compliance rates as the primary outcome. Throughout the implementation period, we will document factors that facilitate or inhibit mNavigator implementation. DISCUSSION: Study findings will inform implementation and scale up of mNavigator in tertiary pediatric cancer facilities in Tanzania, with the goal of facilitating protocol-driven treatment. TRIAL REGISTRATION: The study protocol was registered in ClinicalTrials.gov (NCT03677128) on September 19, 2018.

A Randomized Controlled Trial of an Integrated Alcohol Reduction Intervention in Patients With Hepatitis C Infection.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) and alcohol use are patient risk factors for accelerated fibrosis progression, yet few randomized controlled trials have tested clinic-based alcohol interventions. APPROACH AND RESULTS: A total of 181 patients with HCV and qualifying alcohol screener scores at three liver center settings were randomly assigned to the following: (1) medical provider-delivered Screening, Brief Intervention, and Referral to Treatment (SBIRT), including motivational interviewing counseling and referral out for alcohol treatment (SBIRT-only), or (2) SBIRT plus 6 months of integrated colocated alcohol therapy (SBIRT + Alcohol Treatment). The timeline followback method was used to assess alcohol use at baseline and 3, 6, and 12 months. Coprimary outcomes were alcohol abstinence at 6 months and heavy drinking days between 6 and 12 months. Secondary outcomes included grams of alcohol consumed per week at 6 months. Mean therapy hours across 6 months were 8.8 for SBIRT-only and 10.1 for SBIRT + Alcohol Treatment participants. The proportion of participants exhibiting full alcohol abstinence increased from baseline to 3, 6, and 12 months in both treatment arms, but no significant differences were found between arms (baseline to 6 months, 7.1% to 20.5% for SBIRT-only; 4.2% to 23.3% for SBIRT + Alcohol Treatment; P = 0.70). Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT + Alcohol Treatment (85.7% to 42.1%) arms (P = 0.30). Although both arms reduced average grams of alcohol consumed per week from baseline to 6 and 12 months, between-treatment effects were not significant. CONCLUSIONS: Patients with current or prior HCV infection will engage in alcohol treatment when encouraged by liver medical providers. Liver clinics should consider implementing provider-delivered SBIRT and tailored alcohol treatment referrals as part of the standard of care.

The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial.

INTRODUCTION: Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders. OBJECTIVES: This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV. METHODS: Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed. DISCUSSION: This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.

Exposure to drinking water disinfection by-products and pregnancy loss.

Previous research has suggested that exposure to elevated levels of drinking water disinfection by-products (DBPs) may cause pregnancy loss. In 2000-2004, the authors conducted a study in three US locations of varying DBP levels and evaluated 2,409 women in early pregnancy to assess their tap water DBP concentrations, water use, other risk factors, and pregnancy outcome. Tap water concentrations were measured in the distribution system weekly or biweekly. The authors considered DBP concentration and ingested amount and, for trihalomethanes only, bathing/showering and integrated exposure that included ingestion. On the basis of 258 pregnancy losses, they did not find an increased risk of pregnancy loss in relation to trihalomethane, haloacetic acid, or total organic halide concentrations; ingested amounts; or total exposure. In contrast to a previous study, pregnancy loss was not associated with high personal trihalomethane exposure (> or =75 micro g/liter and > or =5 glasses of water/day) (odds ratio = 1.1, 95% confidence interval: 0.7, 1.7). Sporadic elevations in risk were found across DBPs, most notably for ingested total organic halide (odds ratio = 1.5, 95% confidence interval: 1.0, 2.2 for the highest exposure quintile). These results provide some assurance that drinking water DBPs in the range commonly encountered in the United States do not affect fetal survival.

Racial differences among reasons for participating in research of pregnancy outcomes: the right from the start experience.

BACKGROUND: Historically, racial minorities and women are less likely to participate in medical research than are whites and men. Although much is known about barriers to enrollment for those who decline to participate, much less is known about factors that motivate those who choose to enroll. OBJECTIVE: This study examines the reasons for participation in pregnancy outcomes research and determines whether these reasons varied by race. METHODS: Right From The Start is an ongoing prospective cohort study. Pregnant women aged >or=18 years, who enrolled in and completed the study between December 2000 and June 2003, were interviewed by telephone at the conclusion of their participation and asked about motivators for enrolling. Univariate and bivariate statistics were used to determine the relationship between self-identified race and main reason for participating in the study. Logistic regression was used to adjust for the influence of age, gravidity, education, marital status, and income. RESULTS: A total of 1106 women were interviewed: 735 (66.5%) whites; 285 (25.8%) blacks; 30 (2.7%) Hispanics; and 56 (5.1%) others (Asians, Pacific Islanders). Black women listed a free ultrasound (73/247, 29.6%), contribution to medical knowledge (60/247, 24.3%), wanting to learn about pregnancy health (46/247, 18.6%), and concern about pregnancy health (30.247, 12.1%) as their main reason for participation. Black women were significantly less likely than white women to cite contribution to medical knowledge as the main reason for participation (odds ratio [OR] = 0.44; 95% CI, 0.36-0.63). Blacks were more likely than whites to list wanting to learn about pregnancy health (OR = 3.12; 95% CI, 1.88-5.55) or concern about pregnancy health (OR = 3.0; 95% CI, 1.56-5.94), even after adjusting for age, gravidity, pregnancy loss, education, marital status, and income. CONCLUSIONS: Access to free pregnancy ultrasounds and contribution to medical knowledge were important motivators for both white and black women. However, whereas black women were more likely to report concerns about pregnancy health or pregnancy health education as the main reason for participation, white women were more likely to report a desire to contribute to medical knowledge.

Recruitment for a community-based study of early pregnancy: the Right From The Start study.

Despite the high incidence of spontaneous abortion, little is known about its causes, in part because of the challenge of assembling a large cohort of women in early pregnancy for prospective study. We describe the effectiveness of recruitment strategies used in Right From The Start (RFTS), a prospective, community-based study of spontaneous abortion. Between December 2000 and September 2002, 803 pregnant women enrolled in RFTS, 103 of whom were recruited while trying to conceive. The mean gestational age at enrollment was 52 days, with 25% of the cohort enrolling before 6 completed weeks' gestation. Participants recruited directly from the community typically enrolled earlier in their pregnancies (mean of 44 days) and accounted for 24% of the total cohort and 83% of all participants who were recruited while trying to conceive. Posting brochures in drug stores and targeted mailings to new homeowners were the most effective community recruitment strategies. Recruitment at private and public prenatal care sites accounted for 57% and 19% of the participants respectively. Recruitment from public clinics required direct contact by RFTS staff and yielded women who enrolled at later gestational ages (mean of 58 days), but was valuable for inclusion of minorities and lower income women with less favourable health behaviours. Although intensive, diverse efforts were required, when recruitment efforts were maximised, we successfully recruited over 10% of the estimated number of pregnant women in the community.