Pediatric Cancer, Survivorship
Conditions
Keywords
Aftercare, Health Education, Patient Compliance, Surveillance
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.
Interventions
BEHAVIORALEducational 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 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.
BEHAVIORALFollow-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 or central nervous system (CNS) tumors.
Sponsors
Princess Maxima Center for Pediatric Oncology
Amsterdam UMC
Moi University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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). |
| 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 |
Countries
Kenya
Contacts
Primary ContactSusan Mageto, MPharm
Backup ContactJesse Lemmen, MSc
Outcome results
None listed