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Stiefel MD Anderson OroPharynx cancer (MDA-OPC) cohort: a single-institution, prospective longitudinal outcomes study

Por: Moreno · A. · Sahli · A. J. · Johnson · F. · Sun · X. · Barbon · C. · Rinsurongkawong · W. · Song · W. · Luciani · F. M. · Liang · H. · Li · J. · Liu · W. · Lee · J. J. · Frank · S. · Lai · S. · Fuller · C. · Hutcheson · K. · P01 MD Anderson Oropharynx Cancer Program · Hutcheson · Lai · F
Purpose

The MD Anderson Oropharynx Cancer (MDA-OPC) cohort is a unique single-institution, prospective longitudinal cancer cohort. The cohort aims to enhance the therapeutic index of OPC management by supporting data needs for independent investigators to conduct rigorous observational studies examining exposures and factors associated with acute and late toxicities, cancer progression, recurrence, new malignancies and quality of life in OPC survivors.

Participants

A total of 1811 patients with OPC with a minimum follow-up of 6 months have been consented to our prospective registry between 18 March 2015 and 29 December 2023. Clinical and treatment (Tx) data are available on all patients, including previously untreated patients (1443, 80%). Most previously untreated patients (97%) consented to longitudinal patient-reported outcomes and functional assessments for critical time points including pre-Tx, during-Tx and post-Tx at 3–6 months, 12 months, 18–24 months and annually up to 5 years.

Findings to date

The median age for the MDA-OPC cohort is 66 years (range, 25–96) with the majority being male (89%), white (92%) and with human papillomavirus (HPV)/p16-associated OPC (88%) primarily located in the tongue base or tonsil (90%). For previously untreated patients, 79% were diagnosed with stage I/II disease, and nearly half underwent curative intent chemoradiation. Overall survival was significantly higher for HPV/p16-associated OPC at 1 year (98% vs 93%) and 5 years (83% vs 54%; p

Future plans

Future work includes expansion of the MDA-OPC cohort and survivorship surveillance to 10 years under the recently funded OPC-SURVIVOR research programme (P01CA285249), which aims to identify non-invasive, clinic-ready biomarkers and examine novel phenotypes and mechanistically matched mitigation strategies for latent OPC sequelae. Additionally, we aim to expand our advanced data infrastructure by integrating large data streams from parallel clinical trials and imaging registries.

Trial registration numbers

NCT01893307, NCT03145077.

Online randomised e-hypnotherapy for chronic pelvic pain study (REST): comparing e-hypnotherapy with relaxation and waitlist to improve pain, cost-effectiveness and biopsychosocial outcomes

Por: Evans · S. · Naude · C. · Coitinho Biurra · Y. · Bowring · J. · Knowles · S. · Brooks · T. · Skvarc · D. · Esterman · A. · Fuller-Tyszkiewicz · M. · Klas · A. · Van Niekerk · L. · McCaffrey · N. · Stanley · K. · Druitt · M. · Andrews · J. · Vancaillie · T. · Cheah · S. · Ciccia · D. · Blak
Background

Chronic pelvic pain, defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.

Methods

A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised relaxation control (n=44) or waitlist control (n=44). The primary outcome will be self-reported pain level, and secondary outcomes will include psychological distress, QoL, pain catastrophising, self-efficacy, central sensitisation, somatic symptoms, fatigue and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n=20) and relaxation (n=20) groups to understand meaningful change and barriers/facilitators for ongoing use.

Ethics and dissemination

This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind–body interventions.

Trial registration number

Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.

Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care in African American patients across four cancer centres in the USA: a study protocol

Por: Monton · O. · Drabo · E. F. · Masroor · T. · Fuller · S. · Woods · A. P. · Siddiqi · A. · Malone · T. B. · Johnston · F. M.
Introduction

Despite increasing palliative care capabilities in the USA, utilisation rates remain low for patients with advanced cancer, particularly among African American patients. To address this gap, a theory-driven, stakeholder-informed community health worker (CHW) palliative care intervention for African American patients with advanced cancer and their informal caregivers is currently being assessed through a hybrid type 1 effectiveness-implementation trial at four cancer centres across the USA. To improve the quality and efficiency of palliative care delivery, inform resource allocation and guide broad-scale implementation, it is essential to generate evidence on the economic value of palliative care programmes. The objectives of this study are to evaluate the cost-effectiveness and estimate the social value of a CHW palliative care intervention for African American patients with advanced cancer and their caregivers.

Methods and analysis

We will conduct cost-effectiveness analyses (CEAs) and a social return-on-investment (SROI) analysis to assess the value of the CHW palliative care intervention compared with enhanced standard of care. Standard, extended and distributional CEAs will be performed from the perspectives of an adopting organisation or payer (eg, Medicaid), the US healthcare sector and society. An SROI analysis will also be conducted to assess the social value of the intervention. These analyses will focus on estimating the costs, health and distributional impacts of the intervention.

Ethics and dissemination

This study protocol was approved by the Johns Hopkins Medicine Institutional Review Board (IRB00372476). All methods will be carried out in accordance with relevant guidelines and regulations. Written informed consent will be obtained from all subjects prior to study participation. This manuscript does not contain participant-level data. The full protocol will be available from the corresponding author on reasonable request. The dissemination of findings from the clinical trial and accompanying economic evaluation outlined in this manuscript will be multifaceted to maximise reach and impact. Research findings will be presented at relevant scientific conferences, submitted for publication in peer-reviewed journals and shared with community stakeholders, including hospital leaders and administrators, providers, CHWs and patient advocacy groups.

Trial registration number

NCT05407844.

Duration of COVID-19 symptoms in children: a longitudinal study in a Rio de Janeiro favela, Brazil

Por: Oliveira · F. E. G. · Bastos · L. · de Oliveira · R. d. V. C. · Santos · H. F. P. · Damasceno · L. S. · Franco · L. S. · Carvalho · L. M. A. d. · Fuller · T. L. · Guaraldo · L. · Carvalho · M. · Brasil · P.
Objectives

COVID-19 in children is generally of short duration, but some may take longer to recover. This study investigated the time to symptom resolution following SARS-CoV-2 infection among children in a community setting on the outskirts of an urban centre in Brazil.

Design

Prospective cohort study.

Setting

This is a community-based cohort of children living in Manguinhos, a favela in Rio de Janeiro. The cohort was followed through home visits and telephone monitoring of symptoms. The analysis focused on symptomatic children from this cohort with confirmed SARS-CoV-2 infection. Recovery time was defined as the interval between the first date with symptoms and the first date without symptoms following a positive SARS-CoV-2 test.

Participants

A total of 1276 children (boys and girls aged 2–

Outcome measure

COVID-19 recovery time, assessed based on change points on the symptom persistence probability curve (Kaplan-Meier).

Results

Among children who tested positive, 148 (60%) were symptomatic. The median recovery time was 11 days (IQR: 7–16). Two inflection points were identified on the Kaplan-Meier curve: days 16 and 34. Children who were ill during the Omicron wave took longer to recover. More boys became asymptomatic within the first 15 days; about 93% of girls recovered by day 33, and boys were more common among those who recovered in ≥34 days. Children aged 6–

Conclusions

Among children from a vulnerable area in Rio de Janeiro, recovery time was longer than that reported in other countries, with 9.5% of children experiencing persistent symptoms for more than 33 days. These findings are crucial for understanding the implications of COVID-19 in specific socioeconomic contexts and the dynamics of paediatric recovery in community settings.

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