An interventional study of Educational Program (video, information booklet, Survivorship Card) and Follow-Up Program (form and healthcare provider training) in Pediatric Cancer and Survivorship, sponsored by Moi University. Not yet recruiting at 1 site in Kenya. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Moi University · Not applicable, Interventional, and Health services research
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:
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.
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This study's planned enrollment of 130 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
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Exclusion criteria:
Participants receiving "Usual Care" group (A), will be recruited during the last two months of treatment (T-2). At the end of treatment (T0), participants will complete a knowledge questionnaire and will be followed for another 24 months. At six months after treatment completion (T6), a final follow-up knowledge assessment will be conducted. Participants will be enrolled into group A until the intended sample size of 50 participants is reached. Investigators estimated to have reached this number within four to six months based on recent survival rates.
A similar procedure will apply to the "Educational Intervention" group (B). Participants will complete a knowledge assessment before receiving an educational intervention between T-2 and T0. To evaluate early and late knowledge uptake, participants will complete a post-education knowledge assessment at T0 and a follow-up knowledge assessment at T6. Follow-up adherence will be evaluated at every three months for the first year and at every six months during the second year after treatment completion for both groups. Implementation measures will be captured starting at T3 until T24, together with a satisfaction questionnaire that will be administered at T6.
Behavioral: Educational Program (video, information booklet, Survivorship Card)
Healthcare provider training on survivorship will start at the same timepoint as recruitment of the "Educational Intervention" group (A) at T-2. Follow-Up Forms will be introduced at the outpatient clinic once an estimated 30 healthcare providers have done the training (anticipated at T0). Healthcare providers will fill in a knowledge assessment directly pre- and post-training (T-2) and at six months post-training (T4). Documentation of late effect symptoms will be monitored for twelve months, starting at T0. Implementation measures will be collected weekly starting from T0 and healthcare providers will be assigned to a satisfaction questionnaire at T6.
Behavioral: Follow-Up Program (form and healthcare provider training)
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.
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.
Percentage of non-adherent study participants
When survivors do not appear at a scheduled visit within four weeks before or after the scheduled date.
Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
Percentage of participants lost to follow-up
When survivors miss a scheduled appointment and do not revisit the follow-up clinic after a missed appointment for more than six months.
Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
Reasons for non-adherence (questionnaire)
Reasons for non-adherence (death, relapse, other logistic issues) will be explored through a phone call.
Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
Intentions to revisit the follow-up clinic (questionnaire)
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.
Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months.
Caregiver knowledge (questionnaire)
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.
Time frame: Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment
Healthcare provider knowledge (questionnaire)
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.
Time frame: From start healthcare provider training up to six months after the completion of the training session
Follow-Up Form documented late effects prevalence
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.
Time frame: 12 months: weekly.
Reach caregivers (Implementation measures data collection tool)
Percentage eligible caregivers having received the booklet, video and Survivorship Card, characteristics of caregivers included in the study
Time frame: 24 months: weekly
Reach healthcare providers (Implementation measures data collection tool)
Percentage eligible healthcare providers trained, Characteristics of healthcare providers included in the study
Time frame: 12 months: weekly.
Adoption caregivers (Implementation measures data collection tool)
Percentage study participants taking the Survivorship Card to clinic appointment
Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months
Adoption healthcare providers (Implementation measures data collection tool)
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
Time frame: 12 months: weekly.
Caregiver satisfaction (questionnaire)
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).
Time frame: At 6 months after receiving the educational intervention
Healthcare provider satisfaction (questionnaire)
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).
Time frame: At 6 months after receiving the healthcare provider training
Caregiver recommendations
Open question exploring recommendations to improve educational intervention
Time frame: At 6 months after receiving the educational intervention
Healthcare provider recommendations
Open question exploring recommendations to improve the Follow-Up Form
Time frame: At 6 months after receiving the healthcare provider training
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data that support the findings of this study will be available from the corresponding authors upon reasonable request after publication of all results reporting on the the Primary and Secondary Outcomes of the study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: No end date
Access criteria: Any reasonable request to access underlying study data
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