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Early Supportive Versus Standard Care in Phase I Cancer Trials: A Randomized Controlled Trial.

Anna Casellas-Grau1, Claudia Cruz-Sequeiros2, Sílvia Sala-Suñé3

  • 1Observatory of Psychosocial Care in Cancer, Psycho-Oncology Service, Catalan Institute of Oncology (ICO, IDIBELL) (A.C.G., F.G.), Hospital Duran i Reynals, Barcelona, Spain; Research Group on Attention to Diversity (GRAD), Department of Psychology (A.C.G.), University of Vic-Central University of Catalonia (UVic-UCC), Vic, Spain; Psycho-Oncology and Digital Health Group, Health Services Research in Cancer (A.C.G., F.G.), Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet del Llobregat, Spain.

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Summary

Structured early supportive care (ESC) significantly improved symptom burden and psychosocial needs in Phase I cancer trial patients. This multidisciplinary approach enhances quality of life during challenging early-phase research.

Keywords:
Cancermultidisciplinary committeephase I clinical trialspsychosocial caresocial worksupportive care

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Area of Science:

  • Oncology
  • Clinical Trials
  • Supportive Care

Background:

  • Phase I clinical trials present significant physical and psychological challenges for patients.
  • Evidence for early, structured supportive and palliative care in Phase I populations is limited.
  • Multidisciplinary supportive approaches may enhance symptom control and patient outcomes.

Purpose of the Study:

  • To assess the impact of a structured early supportive care (ESC) program on quality of life in Phase I clinical trial patients.
  • The program utilized systematic referrals to Psycho-oncology, Hospital Social Work, and Palliative Care.
  • Quality of life was evaluated across physical, psychological, and social dimensions.

Main Methods:

  • A randomized controlled trial comparing standard care (SC) with the ESC program.
  • The primary outcome was symptom burden (Edmonton Symptom Assessment System - ESAS).
  • Secondary outcomes included psychosocial and sociofamilial needs (ENP-E).

Main Results:

  • Early supportive care (ESC) participants showed improvement in symptom burden and psychosocial needs, unlike the SC group.
  • Statistical analysis revealed significantly lower ESAS scores in the ESC group (β=-14.44).
  • Improvements in sociofamilial needs were noted for distance and guidance aspects.

Conclusions:

  • Early, structured supportive care significantly improves symptom control and psychosocial well-being in Phase I cancer trial patients.
  • This highlights the value of tailored, multidisciplinary supportive care models for early-phase cancer research.
  • The findings support the integration of ESC into Phase I clinical trial protocols.