Clinical trial NCT06680687: Survivorship Intervention Program in Western Kenya: Study Protocol
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Survivorship
Keywords: Aftercare
Health Education
Patient Compliance
Surveillance
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: Princess Maxima Center for Pediatric Oncology
name: Amsterdam UMC
First posted: 2024-11-08
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A caregiver control group of 50 participants receiving usual care will be recruited and sequentially, 50 caregivers will be included in the intervention group. Because follow-up adherence is also time-dependent (the risk of non-adherence increases with time), the investigators reasoned that the Educational Program should be delivered before completion of treatment, to prevent survivors getting lost to follow-up before receiving the intervention.

Healthcare provider training will be provided to at least 75 percent of the healthcare providers that match the inclusion criteria and timing of the training will be determined by availability. The Follow-Up Form will be used to document late effects in all survivors that attend the outpatient clinic, regardless enrollment in the Educational Program.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Percentage of non-adherent study participants
timeFrame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
measure: Percentage of participants lost to follow-up
timeFrame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
measure: Reasons for non-adherence (questionnaire)
timeFrame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
measure: Intentions to revisit the follow-up clinic (questionnaire)
timeFrame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
Secondary outcomes:
measure: Caregiver knowledge (questionnaire)
timeFrame: Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment
measure: Healthcare provider knowledge (questionnaire)
timeFrame: From start healthcare provider training up to six months after the completion of the training session
measure: Follow-Up Form documented late effects prevalence
timeFrame: 12 months: weekly.
measure: Reach caregivers (Implementation measures data collection tool)
timeFrame: 24 months: weekly
measure: Reach healthcare providers (Implementation measures data collection tool)
timeFrame: 12 months: weekly.
measure: Adoption caregivers (Implementation measures data collection tool)
timeFrame: 24 months: at 3, 6, 9, 12, 18 and 24 months
measure: Adoption healthcare providers (Implementation measures data collection tool)
timeFrame: 12 months: weekly.
measure: Caregiver satisfaction (questionnaire)
timeFrame: At 6 months after receiving the educational intervention
measure: Healthcare provider satisfaction (questionnaire)
timeFrame: At 6 months after receiving the healthcare provider training
measure: Caregiver recommendations
timeFrame: At 6 months after receiving the educational intervention
measure: Healthcare provider recommendations
timeFrame: At 6 months after receiving the healthcare provider training
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
state: Rift Valley
Study officials:
affiliation: Moi University
name: Festus Njuguna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: