Survivorship Intervention Program in Western Kenya: Study Protocol

Официальное название

A Non-randomized Prospective Cohort Study to Improve Follow-up Adherence, Survivorship Knowledge and Late Effects Documentation at a Childhood Cancer Clinic in Western Kenya: A Study Protocol

Обзор

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.

Подробное описание

This non-randomized prospective cohort study will be performed at a referral hospital in Western Kenya. Hundred caregivers of children diagnosed with cancer, who will complete treatment within two months, will be enrolled and followed for 24 months after completion of treatment. A caregiver control group receiving usual care will be recruited and sequentially, caregivers will be included in an intervention group to attend an educational group session and receive educational materials (video, booklet and Survivorship Card). Primary study outcome will be survivors' follow-up adherence. Survivors will be considered lost to follow-up after missing a scheduled appointment and subsequently do not revisit the clinic for more than six months. Mixed models regression analyses will be performed to determine intervention effects on follow-up adherence and secondly on caregiver survivorship knowledge uptake. Additionally, healthcare providers will be trained on follow-up care, whereafter a form will be introduced at the outpatient clinic to document late effects in pediatric survivors attending the clinic for the period of a year. Secondary outcomes will be late effects prevalence as documented in the Follow-Up Form and healthcare provider survivorship knowledge uptake. Implementation measures (reach, potential effectiveness, adoption, satisfaction and maintenance) will be evaluated for both programs.

Вмешательства

• Поведенческое 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 c
• Поведенческое 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

Первичные конечные точки

• Percentage of non-adherent study participants [Срок оценки: 24 months: at 3, 6, 9, 12, 18 and 24 months.]
• Percentage of participants lost to follow-up [Срок оценки: 24 months: at 3, 6, 9, 12, 18 and 24 months.]
• Reasons for non-adherence (questionnaire) [Срок оценки: 24 months: at 3, 6, 9, 12, 18 and 24 months.]
• Intentions to revisit the follow-up clinic (questionnaire) [Срок оценки: 24 months: at 3, 6, 9, 12, 18 and 24 months.]

Вторичные конечные точки (11)

• Caregiver knowledge (questionnaire) [Срок оценки: Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment]
• Healthcare provider knowledge (questionnaire) [Срок оценки: From start healthcare provider training up to six months after the completion of the training session]
• Follow-Up Form documented late effects prevalence [Срок оценки: 12 months: weekly.]
• Reach caregivers (Implementation measures data collection tool) [Срок оценки: 24 months: weekly]
• Reach healthcare providers (Implementation measures data collection tool) [Срок оценки: 12 months: weekly.]
• Adoption caregivers (Implementation measures data collection tool) [Срок оценки: 24 months: at 3, 6, 9, 12, 18 and 24 months]
• Adoption healthcare providers (Implementation measures data collection tool) [Срок оценки: 12 months: weekly.]
• Caregiver satisfaction (questionnaire) [Срок оценки: At 6 months after receiving the educational intervention]
• Healthcare provider satisfaction (questionnaire) [Срок оценки: At 6 months after receiving the healthcare provider training]
• Caregiver recommendations [Срок оценки: At 6 months after receiving the educational intervention]
• Healthcare provider recommendations [Срок оценки: At 6 months after receiving the healthcare provider training]

Критерии участия

Критерии включения

• Caregivers of children diagnosed with cancer (primary or secondary malignancy) below fifteen years old.
• Children will soon be finalizing childhood cancer treatment (enrolled during the last 2 months of treatment).
• Healthcare providers (the pediatric oncology workforce comprises of an estimated 30 staff members) working in the Pediatric Oncology department at MTRH will be recruited.
• Any cadre involved in patient care or patient education (e.g. pediatric oncologists, fellows, registrars, medical officers, clinical officers, nurses, patient navigators, child life specialists) will be allowed to participate.

Критерии исключения

• Childhood cancer patients should have no treatment failure (abandonment, relapsed disease, progressive disease).
• Caregivers of children with a relapsed malignancy in remission will be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Kenya · 1 центр

• Moi Teaching and Referral Hospital — Eldoret

Публикации

• Lemmen J, Mageto S, Vik T, Olbara G, Kaspers G, Njuguna F. Non-randomised prospective clinical trial to improve follow-up adherence, survivorship knowledge and late effects documentation at a childhood cancer clinic in Western Kenya: a study protocol. BMJ Open. 2025 Jun 10;15(6):e096741. doi: 10.1136/bmjopen-2024-096741. PMID 40499965

Идентификаторы

NCT: NCT06680687 · 0004807

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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