Patient Advocates for Clinical Research (PACER): A Step Toward Ethical, Relevant, and Truly Participatory Clinical Research in India.

Background Clinical research presents a promising path for improving healthcare in contemporary India. Yet, researchers identify gaps in trust, awareness, as well as misconceptions about being a '"guinea pig." We proposed building the capacity of training patient advocacy groups (PAGs) in patient-centered clinical research and through them creating aware patients as research partners. Methodology Patient Advocates for Clinical Research (PACER) is a tiered program to share information and education about clinical research with PAGs. Tier one is a self-paced online learning course, followed by workshops on clinical research, Good Clinical Practice, research consent, case studies, and group discussions. Results A total of 20 PAGs represented by 48 participants, active in areas of pediatric cancer, breast cancer, multiple myeloma, type I diabetes, spinal muscular atrophy, sickle cell disease, and inflammatory bowel diseases, participated. Among 48 participants 30 successfully completed the online course (multiple-choice question evaluation score cut-off >70%), attaining an average score of 23.9 ± 2.1 out of 30. Overall, 48 participants attended workshop 1 and 45 workshop 2, with 140 participants joining the focus group discussion (FGD). An overall improvement of 9.4% (𝜒2 = 46.173; p < 0.001) for workshop 1 and 8.2% (𝜒2 = 25.412; p < 0.001) for workshop 2 was seen in knowledge gain about clinical research. The FGD raised issues such as misleading information from research teams, unethical recruitment, incomprehensible information sheets, and limited trial-related knowledge fostering fear of participation in clinical research. Conclusions Multimodal and tiered learning of clinical research such as that used by PACER has a good participatory and learning response from PAGs and may be further explored.

Sex Bias in Treatment Abandonment of Childhood Cancer in India.

OBJECTIVES: To explore the magnitude of sex bias and determinants of treatment abandonment (TA) in childhood cancer in India. METHODS: Individual data of children (0-19 y) registered between January 1, 2017 and July 31, 2022, was compiled. TA was defined as defaulting curative intent treatment ≥4 wk. Defaulting treatment irrespective of intent ≥4 wk was defined as Treatment Default (TD). The primary outcome was the proportion of male-to-female children with TA. Secondary outcomes included the proportion of male-to-female children with upfront TA, TA at relapse, TD, TD-p (TD only in the palliative setting). The impact of clinico-demographic factors on TA was analysed using multivariable regression and propensity score matching (PSM). RESULTS: Three thousand two hundred eighty four patients were analysed. The overall male-to-female ratio (MFR) was 2.08 (95% CI 1.94-2.24). Of 2906 patients treated with curative intent, 415 (14·3%) abandoned treatment. TA was higher in females than males (16·4% vs. 13·3%; p = 0·022) with adjusted MFR of 0·81 (0·66-0·98). The adjusted MFR of TA for treatment-naïve and relapsed patients and TD were 0·73 (0·59-0·91), 1·13 (0·65-1·96) and 0·84 (0·71-1·00) respectively. Sex independently predicted TA on multivariable analysis. However, on PSM analysis including socio-economic variables, lower maternal education predicted higher TA in children with cancer (10·1% vs. 6%, p = 0·015). CONCLUSIONS: Child sex predicted TA in childhood cancer in India with more females abandoning treatment. Maternal education is a more crucial factor predicting TA over child sex, when socio-economic factors were considered. Hence, policies promoting female education and gender equality may mitigate sex-based gaps in childhood cancer care.

Shared care for children with cancer in India through social and healthcare partnerships during the COVID-19 pandemic.

BACKGROUND: The COVID pandemic posed a challenge for the tertiary centers to continue treatment. Some tertiary centers were designated as COVID-only hospitals, making it difficult for existing childhood cancer patients to continue their treatment at those centres. The need for shared care in childhood cancer was perceived by Cankids and its partnering childhood cancer-treating centers in North and East India. AIM: We aim to show how Cankids upscaled its shared care model to ensure that COVID designated hospitals connected with other hospitals who have to continue to provide care to childhood cancer patients in the pandemic and thus ensured the continuation of treatment for these patients. METHODS AND RESULT: The need assessment of the beneficiaries was done in discussion with the hospital of origin and destination hospital. The need for shared care was also discussed with the families and consent was taken before shifting their children. Cankids with the help of advisors identified cases of high risk that need immediate attention, proactive regular monitoring, and help in care planning with the perspective and recommendation of the multiple providers. The shared care unit came forward with reasonable and discounted packages for treatment. There was a total of five hospitals requiring shared care, and 55 children were supported from April to November 2020. The median age was 8 years and their hospital of origin are in Bihar, Uttar Pradesh, West Bengal, and Delhi. The expenditure on the treatment of the 55 patients was INR 61 61 636 ($ 84 843), with a median of INR 41765 (IQR 19491-174 129) on each patient. Total 291 trips for the transport were arranged and all the patients combined stayed 174 days at Cankids accommodation facility. CONCLUSION: The shared care helped the patients access standard treatment and reduce the financial burden.

Impact of COVID-19 nationwide lockdown on retinoblastoma treatment and outcome: A study of 476 eyes of 326 children.

Purpose: The novel coronavirus SARS-CoV-2 (COVID-19) and the resultant nationwide lockdown and travel restrictions led to difficulty in providing timely and regular treatment to patients with childhood cancers such as retinoblastoma. This study is aimed at assessing the demography, clinical presentation, treatment strategies, and outcome of treatment defaulters due to the lockdown. Methods: Cross-sectional, observational study of retinoblastoma patients at a tertiary care ocular oncology center during the first wave of COVID-19 and the resulting nationwide lockdown. Results: Of the 476 eyes of 326 patients undergoing active management with a median age of 57 months (range: 4-214 months), 205 (63%) patients returned for follow-up after a mean delay of 45.8 ± 24.3 weeks (range: 8-80 weeks) and 121 (37%) were defaulters according to the data analyzed till June 30, 2021. Distance of residence was ≥1000 km for 148 patients (46%). In terms of need for active treatment, the number of emergent cases was 2 (<1%), 11 (3%) were urgent, and 313 (96%) were semi-urgent. International classification groups D (n = 107 eyes, 23%) and E (n = 173 eyes, 36%) were in majority, and 13 eyes (4%) and 4 eyes (1%) were at stages 3 and 4, respectively. Prior to lockdown, 86 eyes (18%) had active tumor, which remained unchanged (n = 26, 30%) or worsened (n = 49, 60%) after failure to follow-up. Vision (47%), eye (92%), and life salvage (98%) were achieved by individualized protocol-based management after the patients returned for further management. Five children succumbed to intracranial extension. Conclusion: The COVID-19-related nationwide lockdown has deprived retinoblastoma patients of optimal and timely management, leading to prolonged treatment interruptions, delays, permanent default, and death. It is of paramount importance for all the stakeholders to increase awareness, make necessary travel and logistic arrangements, and ensure continuity of care for children with retinoblastoma.

Estimated National and State Level Incidence of Childhood and Adolescent Cancer in India.

BACKGROUND: Hitherto, incidence burden of childhood cancer in India has been derived from GLOBOCAN data. Recent analyses have challenged whether this accurately measures the true incidence of childhood cancer. OBJECTIVE: To use observed data rather than simulation to estimate the number of children (0-14 years), as well as number of children and adolescents (0-19 years), in India who develop cancer every year at the national and state/union territory (UT) level. METHODS: Age-specific (five year groups), sex-specific, and state/UT specific population data from India Census 2011 was used. Global average incidence rates from the International Incidence of Childhood Cancer 3 (IICC3) report were used. Incidence rates per million person-years for the 0-14 years and 0-19 years age groups were age-adjusted using the world standard population to provide age-standardized incidence rates, using the age-specific incidence rates for individual age groups (0-4 years, 5-9 years, 10-14 years, and 15-19 years). RESULTS: The national number of children (0-14 years) and, children and adolescents (0-19 years) that may develop cancer every year based on 2011 census are 52,366 and 76,805 persons respectively. Cancer type specific incidence is provided for each state/UT for these age ranges. This national incidence is approximately double of the GLOBOCAN 2018 estimates of incidence of children diagnosed and registered with cancer and the differential is greater in girls. CONCLUSIONS: Our analysis proposes new estimates of incident childhood cancer cases in India for children and adolescents. Future regional, national and international research on childhood cancer epidemiology and healthcare accessibility would help further refine these estimates.

Pilot initiative in India to explore the gonadal function and fertility outcomes of a cohort of childhood cancer survivors.

CONTEXT: Steady improvement in childhood cancer outcomes has led to a growing number of survivors, many of who develop long-term sequelae. There is limited data about these sequelae (including those related to fertility) on childhood cancer survivors from India. AIMS: We undertook a prospective pilot study on childhood cancer survivors from India to assess their gonadal function and fertility. SUBJECTS AND METHODS: A pediatric oncologist and a reproductive medicine specialist assessed 21 childhood cancer survivors. The risk of infertility was established using disease and treatment variables. Current status of puberty, sexuality, and fertility were assessed using clinical and biochemical parameters. Outcomes were correlated with risk group of infertility. Information was also ascertained on counseling with regards to risk of infertility. RESULTS: The cohort included 21 survivors (71% males) with a median age of 18 years who were off treatment for a median age of 7 years. Ten (48%) survivors were at low risk for infertility, 9 (43%) at medium risk and 2 (9%) at high risk. Gonadal dysfunction was seen in 3 (14%) survivors: 0/10 (0%) low risk, 1/9 (11%) medium risk, and 2/2 (100%) high risk. None of the survivors, who are at high risk or medium risk of infertility, received any counseling before treatment. CONCLUSIONS: This prospective pilot study of a cohort of childhood cancer survivors from India demonstrates a deficiency in the information provided and counseling of patients/families at the time of diagnosis with regards to the risk of infertility. Fertility outcomes of childhood cancer survivors were congruent with recognized risk groups for infertility. Future action points have been identified.