Survivorship Intervention Program in Western Kenya: Study Protocol
- Conditions
- Pediatric CancerSurvivorship
- Registration Number
- NCT06680687
- Lead Sponsor
- Moi University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Percentage of non-adherent study participants 24 months: at 3, 6, 9, 12, 18 and 24 months. When survivors do not appear at a scheduled visit within four weeks before or after the scheduled date.
Percentage of participants lost to follow-up 24 months: at 3, 6, 9, 12, 18 and 24 months. When survivors miss a scheduled appointment and do not revisit the follow-up clinic after a missed appointment for more than six months.
Reasons for non-adherence (questionnaire) 24 months: at 3, 6, 9, 12, 18 and 24 months. Reasons for non-adherence (death, relapse, other logistic issues) will be explored through a phone call.
Intentions to revisit the follow-up clinic (questionnaire) 24 months: at 3, 6, 9, 12, 18 and 24 months. Intentions to revisit the follow-up clinic (yes/no, what can hospital do to support participant in adhering to follow-up visit) will be explored through a phone call.
- Secondary Outcome Measures
Name Time Method Healthcare provider satisfaction (questionnaire) At 6 months after receiving the healthcare provider training Satisfaction questionnaire rating satisfaction on a 5-point Likert scale (highest score indicating maximum satisfaction, and lowest score indicating maximum satisfaction for inverse questions). Values can range from minimum 1 (Strongly Disagree) to maximum 5 (Strongly Agree).
Caregiver recommendations At 6 months after receiving the educational intervention Open question exploring recommendations to improve educational intervention
Healthcare provider recommendations At 6 months after receiving the healthcare provider training Open question exploring recommendations to improve the Follow-Up Form
Caregiver knowledge (questionnaire) Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment Caregivers' knowledge about disease history, treatment exposure, associations between treatment and late effects, follow-up care, late effects risk and risk perception.
Levels of knowledge (number of accurate/inaccurate/unknown responses), and knowledge uptake (changes in number of accurate responses) progression will be followed over time.Healthcare provider knowledge (questionnaire) From start healthcare provider training up to six months after the completion of the training session Caregivers' and healthcare providers' knowledge about disease history, treatment exposure, associations between treatment and late effects, follow-up care, late effects risk and risk perception according
Levels of knowledge (number of accurate/inaccurate/unknown responses), and knowledge uptake (changes in number of accurate responses) progression will be followed over time.Follow-Up Form documented late effects prevalence 12 months: weekly. The prevalence of late effects will be described as the percentage of individual survivors visiting the outpatient clinic for the duration of one year that reported a symptom (yes/no) as documented in the follow-up forms.
Late effects are categorized into physical outcomes (e.g. relapsed disease, heart failure), physical aspects of quality of life (e.g. fatigue, challenges exercising), psychosocial aspects of quality of life (e.g. anxiety, exclusion), neurocognitive aspects of quality of life (memory, educational problems) according to the International Childhood Cancer Outcome Project.Reach caregivers (Implementation measures data collection tool) 24 months: weekly Percentage eligible caregivers having received the booklet, video and Survivorship Card, characteristics of caregivers included in the study
Reach healthcare providers (Implementation measures data collection tool) 12 months: weekly. Percentage eligible healthcare providers trained, Characteristics of healthcare providers included in the study
Adoption caregivers (Implementation measures data collection tool) 24 months: at 3, 6, 9, 12, 18 and 24 months Percentage study participants taking the Survivorship Card to clinic appointment
Adoption healthcare providers (Implementation measures data collection tool) 12 months: weekly. Percentage eligible survivors having received the follow-up form in clinic; Percentage follow-up forms completely filled by clinician; Investigations and referrals done; Actions adhering to form instructions
Caregiver satisfaction (questionnaire) At 6 months after receiving the educational intervention Satisfaction questionnaire rating satisfaction on a 3-point Likert scale (highest score indicating maximum satisfaction, and lowest score indicating maximum satisfaction for inverse questions). Values can range from minimum 1 (Disagree) to maximum 3 (Agree).
Trial Locations
- Locations (1)
Moi Teaching and Referral Hospital
🇰🇪Eldoret, Rift Valley, Kenya