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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Moi University
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Percentage of non-adherent study participants
Study Overview
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:
- increase follow-up adherence of childhood cancer survivors;
- increase caregivers' and healthcare providers' knowledge about childhood cancer diagnoses, treatment and the corresponding late effects risks;
- document late effects at a childhood cancer outpatient clinic;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
"Follow-Up Forms implementation"
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.
Intervention: Follow-Up Program (form and healthcare provider training) (Behavioral)
"Usual Care"
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.
"Educational Intervention"
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.
Intervention: Educational Program (video, information booklet, Survivorship Card) (Behavioral)
Outcomes
Primary Outcomes
Percentage of non-adherent study participants
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Caregiver recommendations(At 6 months after receiving the educational intervention)
- Healthcare provider satisfaction (questionnaire)(At 6 months after receiving the healthcare provider training)
- Healthcare provider recommendations(At 6 months after receiving the healthcare provider training)
- Caregiver knowledge (questionnaire)(Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment)
- Healthcare provider knowledge (questionnaire)(From start healthcare provider training up to six months after the completion of the training session)
- Follow-Up Form documented late effects prevalence(12 months: weekly.)
- Reach caregivers (Implementation measures data collection tool)(24 months: weekly)
- Reach healthcare providers (Implementation measures data collection tool)(12 months: weekly.)
- Adoption caregivers (Implementation measures data collection tool)(24 months: at 3, 6, 9, 12, 18 and 24 months)
- Adoption healthcare providers (Implementation measures data collection tool)(12 months: weekly.)
- Caregiver satisfaction (questionnaire)(At 6 months after receiving the educational intervention)