Warren Bacorro

Shared Decision Making in Oncology and Its Implementation in Cervical Cancer Management in the Philippines: A Narrative Review

PURPOSE Shared decision making (SDM) is an approach where clinicians and patients make decisions together using the best available evidence. Although much studied, recognized to be ethically imperative, and recommended in international health policies, it remains poorly implemented. In the Philippines, there are limited studies on patient decision making preferences and SDM. Practical guidance on the implementation of SDM or use of patient decision aids (PtDAs) is often not detailed in existing national clinical practice guidelines in oncology. METHODS We performed a systematic search of Philippine literature on SDM in oncology and an iterative review of international literature on the philosophy and methods of SDM, the utility and effectiveness of PtDAs, and the facilitators and barriers to implementation or usage. We contextualized our review to the cervical cancer management and health service delivery in the Philippines. RESULTS Local literature is limited to five scientific publications and two registered studies. International literature encompasses patient decisional preferences, the role of PtDAs and the standards for their development and evaluation, their effectiveness, and barriers and facilitators to their use in cancer-related decision making. We discussed the implications on the management of cervical cancer in the Philippines, challenges in health service delivery and standards, and SDM research. CONCLUSION Local SDM research is limited. Our preliminary experience in a multicenter clinical trial in Manila on PtDA use in the framework of SDM in cervical cancer suggest good patient and clinician acceptability. Challenges to implementation such as unfavorable financial situations, urgency of clinical decisions, low patient or caregiver educational attainment, and poor integration of multidisciplinary and SDM in organizational workflows will be important when implementing SDM in different settings.

A systematic review of the barriers to implementing human papillomavirus vaccination programs in low‐ and middle‐income countries in the Asia‐Pacific

AbstractAim: The increasing burden of human papillomavirus (HPV)‐related diseases in low‐ and middle‐income countries (LMICs) could be alleviated by effective HPV vaccination programs. In this systematic review, we examined barriers to introduction, implementation, and/or sustainability of HPV vaccination programs in LMICs in the Asia‐Pacific region (AP‐LMICs).Methods: A systematic search of literature from the past 10 years (2010‐2019) was performed through PubMed, Cochrane CENTRAL, and Google Scholar. Studies were included if they reported barriers to HPV vaccination in AP‐LMICs. All study designs were included except commentaries and editorials. The journal articles were assessed using the Joanna Briggs Institute critical appraisal checklists.Results: A total of 46 eligible articles were included. An increase in publications was noted from 2010 to 2019. Barriers were diverse and were classified into four levels––government, healthcare providers (HCPs), society, and individual. The top specific barriers that were identified across AP‐LMICs are lack of funding and political support at the government level, lack of awareness among HCP and lack of vaccination programs at the level of health providers, and the perceived cost/benefit ratio for the individual level.Conclusion: Barriers to successful implementation of HPV vaccination programs differ among Asia‐Pacific LMICs. Policymakers will need to evaluate the relative importance of these barriers in their target areas and population in order to draft an effective dissemination and implementation strategy.

Phase 1/2 trial evaluating the effectiveness and safety of dose-adapted Hypofractionated pelvic radiotherapy for Advanced Cervical cancers INeligible for ChemoTherapy (HYACINCT)

The standard treatment for locally advanced cervical cancer (LACC) is concurrent chemoradiation (CRT) followed by brachytherapy (BRT). The addition of chemotherapy (ChT) to radiotherapy (RT) is associated with a 7.5% improvement in overall survival but with more grade 3-4 acute toxicities (16.4% vs 4.9%, CRT vs RT alone). The risk-benefit ratio could be less favorable in advanced disease with renal dysfunction secondary to tumor-related hydronephrosis; borderline cardiac function; and frail patients. RT alone followed by BRT achieves long-term locoregional control <62%. Hypofractionated RT (HF-RT) using older techniques result in comparable disease control and low late toxicity rates (4-8%). Dose-adapted HF-RT using intensity-modulated RT with nodal simultaneous integrated boost (nSIB) could improve tumor control and toxicity, when ChT is contraindicated. The HYACINCT study is a two-phase study to determine the effectiveness and safety of HF-RT with nSIB in LACC when ChT is contraindicated. Phase 1 is a dose-escalation study using standard 3 + 3 design, to determine the maximum tolerated dose (MTD) for nSIB in combination with pelvic HF-RT (2.67 Gy x 15 fractions). Phase 2 is a single-arm clinical trial using Simon's two-stage design, to assess the efficacy of HF-RT with nSIB in terms of tumor response. Adult women with biopsy-proven, untreated LACC, with contraindication to ChT will be included in this trial. For the phase 1, the primary endpoint is dose-limiting toxicity (DLT), or any grade ?3 acute or sub-acute toxicity. The dose level at which incidence of DLT is ?33% is defined as the maximum tolerance dose (MTD). For the phase 2, the primary endpoint is complete response at 3 months post-treatment. Secondary outcomes are progression-free and overall survival, acute and late toxicity, and patient-reported outcomes (EPIC, EORTCQLQ C30 + CX24, PGIC, PCIS). Trial registration: NCT05210270.

Challenges and opportunities in the implementation of advanced brachytherapy programs for cervical cancer in the Philippines

AbstractCervical cancer is the second most common cancer cause of morbidity and mortality in Filipino women; the age‐standardized annual incidence is 15.2 as of March 2023. The majority are diagnosed at a locally advanced stage and in the reproductive and working age group. This results in important treatment and productivity costs. The importance of image‐guided and interstitial brachytherapy (BRT) in local control and toxicity outcomes has been shown in recent meta‐analyses. We review the status of advanced BRT program training and implementation in the Philippines and important challenges and opportunities to move forward.

Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer: Development, Alpha Testing, and Peer Validation

PURPOSEIn locally advanced cervical cancer (LACC), adding cisplatin to radiotherapy (RT) improves survival but increases toxicity. Among patients with cisplatin contraindications, RT compliance may be compromised by toxicity because of cisplatin or a substitute. In shared decision making, a patient decision aid (PtDA) may decrease decisional conflict and attitudinal barriers, thereby improving treatment compliance.METHODSFollowing International Patient Decision Aid Standards (IPDAS) guidelines, a steering committee of two radiation oncologists, a gynecologic oncologist, an oncology nurse, a clinical psychologist, a cancer survivor, and a caregiver developed the chemotherapy or exclusion in cisplatin-intolerant patients with LACC (CECIL) prototype, a PtDA for cisplatin-intolerant patients with LACC deciding about adding chemotherapy to RT. The prototype was alpha-tested using the e-Delphi method. The patient decision aid research group Ottawa Acceptability Questionnaire was used to evaluate comprehensibility, length, amount of information, neutrality, and overall suitability for decision making. The prototype was then independently evaluated by local internal, local external, and international reviewers using the IPDAS checklist version 4, which encompasses information, probabilities, values, guidance, development, evidence, disclosure, plain language, and evaluation.RESULTSAlpha testing showed high practitioner acceptability (all items with mean and median scores ≥4; overall mean score 4.70 of 5.00) and good patient acceptability (all items rated good to excellent). Content validation showed that the PtDA satisfied all IPDAS six qualifying and six certification criteria, with high overall mean score (3.63 of 4.00) for all 17 applicable quality criteria.CONCLUSIONThe CECIL prototype shows good practitioner and patient acceptability, and content validity on peer review. Clinical testing to determine its effectiveness in reducing decisional conflict is ongoing.

Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer

The goal of this clinical trial is to investigate the utility and effectiveness of a decision aid in cisplatin-intolerant patients with locally advanced cervical cancer. The main questions it aims to answer are: 1. What is the effectiveness of the decision aid in reducing decisional conflict? 2. What is the utility of the decision aid in preparing for decision-making? Participants will be asked to accomplish the Decisional Conflict Scale before and after using the decision aid. Researchers will compare patients given routine care and the decision aid with patients given routine care to see if the decision aid reduces decisional conflict.