Survivorship Intervention Program in Western Kenya: Study Protocol

NCT06680687 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-11-12

No results posted yet for this study

Summary

In this study protocol, the investigators described a survivorship intervention program that will be performed at a referral hospital in Western Kenya. This will be a non-randomized prospective cohort study with a sequential hybrid effectiveness - implementation design. The study comprises of an educational component for caregivers of childhood cancer survivors and a follow-up component targeting healthcare providers with survivorship training and implementation of a late effects documentation tool.

Through these interventions the investigators aim to:

1. increase follow-up adherence of childhood cancer survivors;
2. increase caregivers' and healthcare providers' knowledge about childhood cancer diagnoses, treatment and the corresponding late effects risks;
3. document late effects at a childhood cancer outpatient clinic;
4. evaluate program implementation and satisfaction among recipients and providers.

Conditions

  • Pediatric Cancer
  • Survivorship

Interventions

BEHAVIORAL

Educational Program (video, information booklet, Survivorship Card)

Caregivers will be invited to attend an educational group session. Each session will be organized weekly to monthly. A maximum of ten caregivers can be present at a session. First a video will be displayed in which healthcare providers explain medical aspects of survivorship. Caregivers of survivors and young adult survivors discuss experiences after completing cancer treatment in the video. Secondly, the present healthcare provider will hand over an information booklet 'Life after childhood cancer' to the caregivers. The booklet covers similar topics as presented in the video. Lastly, a Survivorship Card will be shared with the caregivers. The card contains a record of the patient's cancer and treatment history and the expected follow-up appointment schedule. The survivor and family take one card home and a duplicate copy of the card remains in the medical file.

BEHAVIORAL

Follow-Up Program (form and healthcare provider training)

Healthcare providers will attend a training session of approximately 90 minutes, in which investigators will discuss the same topics as covered in the educational group session supported by PowerPoint slides. A Follow-Up Form will be introduced to be used by healthcare providers in the outpatient follow-up clinic. The form will include questions referring to symptoms specific for certain late effects. Specific questions will be included per subcategory: hematological malignancies, solid tumors or central nervous system (CNS) tumors.

Sponsors & Collaborators

  • Princess Maxima Center for Pediatric Oncology

    collaborator OTHER
  • Amsterdam UMC

    collaborator OTHER
  • Moi University

    lead OTHER

Principal Investigators

  • Festus Njuguna, MD, PhD · Moi University

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680687 on ClinicalTrials.gov