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
Phase: NA
Conditions: Pediatric Cancer, Survivorship
Sponsor: Moi University

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Childhood Cancer Survivorship Intervention Program in 
Western Kenya 
 
PROTOCOL VERSION: 01-05-2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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AUTHORS AND AFFILITATIONS 
 
Jesse Lemmen, MD1,2, Susan Mageto, MPharm1,3,4, Terry A. Vik, MD3,5, Gilbert 
Olbara, MD6, Saskia Mostert, MD, PhD1,2, Gertjan Kaspers, MD, PhD1,2, Festus 
Njuguna, MD, PhD3,7  
 
1 Emma Children’s Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam,  Pediatric 
Oncology, Amsterdam,  
the Netherlands 
2 Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands 
3 Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya 
4 Pharmacology, School of Health Sciences, Kisii University  
5 Pediatrics, Indiana University School of Medicine, Indianapolis, United States of America 
6 Department of Pediatric Oncology, Moi Teaching and Referral Hospital, Eldoret, Kenya                              
7 Department of Child Health and Pediatrics, Moi University, Eldoret, Kenya 
 
BACKGROUND/ LITERATURE REVIEW 
 
Survival of childhood cancer in Kenya has increased in the last decade.1,2 As a result, 
an emerging number of childhood cancer survivors will be in need of care. Survivors 
may experience either physical or psychosocial late effects due to treatment toxicity.3,4 
In addition, survivors are vulnerable to challenges regarding education, career, 
relationships and financial security.5,6  
 
International survivorship guidelines incorporate follow-up strategies to prevent, detect 
and manage late effects.7,8 Also, survivorship care plans have been implemented to 
increase cancer knowledge among survivors, increase their follow-up adherence, and 
enhance their perception and risk of late effects.9,10  
 
Despite the attempt to harmonize guidelines suitable for a diverse international clinical 
practice, current recommendations do not seem to reflect the every-day reality of 
pediatric oncology care in low and middle-income countries (LMICs). A survey among 
South-African pediatric oncology healthcare providers, showed that most clinicians 
need to adapt existing guidelines according to their local practice.11 Insufficient staffing, 
a lack of time and possibly knowledge, may hamper healthcare providers to provide 
optimal survivorship care.12 Furthermore, healthcare facilities may not offer necessary 
investigations, or patients may not be able to afford them.11 Without available support 
to sustain follow-up care, follow-up adherence of survivors has traditionally been low 
in LMICs.13,14  
 
Survivorship infrastructure should be strengthened in LMICs, and healthcare providers 
and survivors should be facilitated with practical tools to deliver necessary and holistic 
care taking the local capacity into consideration. Education about therapy-related 
complications or late effects could effectively improve risk awareness, especially when 
delivered at different time points.15 Video-based educational interventions on cancer 
awareness can be beneficial in targeting low-literacy audiences. Dissemination 
through multiple social media platforms can raise attention among different age 
groups.16 
 

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Available studies about follow-up care in Sub-Saharan Africa have mainly focused on 
a single diagnosis or single late effect.17 In reality, many survivors experience a 
multitude of late effects, that may sequentially occur during their lifetime.3 Survivorship 
care plans, comprising of education, a treatment summary, and recommendations 
based on individual, diagnosis or treatment specific risks, have been developed to 
approach late effects from a survivor-centered perspective.10  
 
In Sub-Saharan Africa, particularly the psychosocial long-term burden of childhood 
cancer has received little attention.17 Childhood cancer stigma, experienced in 
healthcare facilities, in school or in families, may contribute to enduring social isolation 
of survivors.18,19 Demystifying childhood cancer and survivorship, may normalize 
disclosure, and eventually reduce psychological distress.20 A compassionate first 
endorsement of a survivors’ cancer history, has showed to be a predictor of future 
disclosure in other social environments.21 Peer support has proven an effective method 
to address the social needs of young cancer survivors and their parents.22,23 Interacting 
with peer survivors could raise self-worthiness and confidence.24 In several low and 
middle-income countries, peer support groups have also gained responsibility for 
integral parts of survivorship services, such as providing rehabilitation aids, covering 
health insurance fees and tracking of patients who are lost to follow-up.25,26  
 
OBJECTIVES 
o Increase adherence to follow up clinic among childhood cancer survivors at 
MTRH 
o Enhance the detection of late effects among childhood cancer at MTRH 
o Increase social reintegration of childhood cancer survivors treated at MTRH 
STUDY DESIGNS 
The survivorship education program will be a prospective comparative study. The 
follow-up program and the support program will be prospective cohort studies but 
without a comparison group. 
SAMPLE SIZE 
Education Program 
The investigators aim to improve follow-up adherence from 30% to 60% at two years 
following treatment completion. To reach 80% statistical power, investigators aim to 
include at least 80 participants. Anticipating that 20% may stop participating in the 
study and may not be reachable afterwards for a knowledge assessment, 
investigators aim to include 50 participants in the control group and 50 in the 
intervention group. 
Follow-Up Program                                                                     
 
Training about childhood cancer survivorship will be provided to an estimated 30 
healthcare providers within the first two months from approval of study. Data from the 

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medical records of childhood cancer survivors attending the follow-up clinic will be 
extracted from the start of the study.  
Support Program 
A maximum of three WhatsApp support groups will be formed for caregivers of 
childhood cancer survivors. Caretakers of 10-15 childhood cancer survivors will 
participate in each WhatsApp support group. 
 
SETTING 
The study will be performed at Moi Teaching and Referral Hospital (MTRH), which is 
situated in Eldoret, Western Kenya. It is a large tertiary care referral hospital whose 
service area covers a population of approximately 24 million. The total bed capacity of 
MTRH is approximately 1,000 of which 35 are for the pediatric oncology department. 
Treatment modalities offered in the department include surgery, chemotherapy, and 
radiotherapy. Yearly an estimated 300 children are diagnosed with cancer, with an 
event-free survival rate of 32%.2 After discharge from the wards, patients are seen in 
the outpatient clinic where follow-up reviews upon treatment completion are also done. 
Roughly 30% of survivors remain in follow-up two years after completion of treatment.  
 
 
 
1) SURVIVORSHIP EDUCATION PROGRAM 
 
The purpose of this part of the study is to investigate whether implementation of a 
Survivorship Education Program results in improved follow-up adherence at the 
outpatient clinic by enhancing knowledge of caretakers. This quasi-experimental / 
comparative prospective study will include 100 participants. The study will take place 
from approval in 2024, up to the moment of reaching the inclusion goal. The 
intervention group of 50 will receive the Survivorship Education Program: a video 
presentation, information booklet and Survivorship Card. The intervention group will 
be compared with a historical control group of 50 caregivers who did not receive a 
video presentation, information booklet and Survivorship Card: the current standard of 
care. 
 
 Inclusion criteria: 
Control group: 
1) Caregivers of children diagnosed with childhood cancer at age 0-14 years with: 
2) No treatment failure (abandonment of treatment, progressive or relapsed 
disease)  
3) Finalizing childhood cancer treatment (in the last 2 months of treatment). 
 
Intervention group: 
1) Caregivers of children diagnosed with childhood cancer at age 0-14 years with:  

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2) No treatment failure (abandonment of treatment, progressive or relapsed 
disease)  
3) Finalizing childhood cancer treatment (in the last 2 months of treatment). 
Study design: 
 
Two Survivorship Education Sessions (one for participants in the outpatient clinic and 
one for participants in the wards) will be provided at MTRH weekly, depending on the 
number of admitted patients who are almost finishing treatment.  
This will be a prospective, comparative study. Investigators aim to improve follow-up 
adherence from 30% to 60% at two years following treatment completion. To reach 
80% statistical power, the aim is to include at least 80 participants (40 in the control 
group, 40 in the intervention group). Anticipating that 20% may stop participating in the 
study and may not be reachable afterwards for a knowledge assessment, the aim is to 
include 50 participants in the control group and 50 in the intervention group. The 
percentage of relapsed disease in the control group after reaching the goal of enrolling 
50 participants should be considered to define the final number of both cohorts. The 
study participants will be identified in the wards and outpatient clinic. Consecutive 
sampling will be used to recruit them from the moment of study approval, planned for 
early 2024, up to the moment of reaching the inclusion goal.  
 
After completing enrolment of the control group in the study (anticipated 3-6 months), 
investigators will begin enrolment of the intervention group and start the Education 
Program. 
 
Figure 1: Time course of Survivorship Education Program 
 
 
 

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Components of Survivorship Education Program: 
a) Video presentation: Caregivers will be invited to attend a video presentation in one 
of the rooms at the Chandaria building during their last two months of treatment. In 
case the person who takes care of the patient in the wards or brings the patient to the 
outpatient clinic is not a primary caregiver, they will be requested to ask the primary 
caregiver to plan and attend the next video presentation. Those attending the 
outpatient clinic (e.g. ALL patients) will be attending the video sessions after their blood 
samples have been taken as they await the results. The video will be shown during a 
group session by a healthcare provider to caregivers of children and teenagers, who 
are soon finalizing their cancer treatment. The video addresses the importance of 
follow-up after completion of treatment, physical late effects, psychosocial late effects, 
stigmatization, social reintegration, and the Survivorship Card usage. In the video, 
healthcare providers explain the medical aspects, and caregivers of survivors and a 
young adult survivor share their experiences. During this group session a healthcare 
provider will be present to answer questions of the attending caregivers. Each session 
will take 60-90 minutes, and will be organized weekly to monthly, depending on the 
availability of study participants.  
b) Information booklet: After watching the video presentation, the accompanying 
healthcare provider will give an illustrated educational information booklet to the 
caregivers. The booklet contains the same topics, covering survivorship information as 
presented in the video: importance of follow-up after completion of treatment, physical 
late effects, psychosocial late effects, stigmatization, social reintegration, the 
Survivorship Card usage and information about coping strategies.  
c) Survivorship Card: After watching the video presentation, the accompanying 
healthcare provider shares the Survivorship Card with the caregivers. An explanation 
about the content and purpose of the Survivorship Card will be given to the caregiver 
individually. This is a record of the patient’s cancer and treatment history and required 
check-ups after treatment completion. It also lists possible late effects of received 
treatment that the caregiver should be aware of. Most information will be pre-filled, 
according to the standard treatment administered per protocol. Personalized 
information will be filled by the treating doctor on the survivorship card at the first follow-
up visit. The survivor and family take one survivorship card home, and a duplicate copy 
of the survivorship card remains in the medical file.  
Participant recruitment: 
Control group: 
Caregivers will be identified weekly at the Pediatric Oncology Unit, during their last 2 
months of treatment. Study information will be provided, and informed consent will be 
requested. Upon approval, a knowledge assessment will take place during their last 2 
months of treatment, and at six months after treatment completion. In case the survivor 
and caregivers do not appear at the six months follow-up appointment, they will be 
called to reschedule their appointment. If they then will still be unable to attend the 
follow-up clinic, caregivers will be requested for a phone interview to assess knowledge 
and satisfaction.  

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Follow-up adherence will be prospectively evaluated by checking in the medical 
records at the end of every weekly clinic day, whether families were present at their 
scheduled hospital appointment at 3, 6, 12, 18 and 24 months after treatment 
completion or not. In case of follow up non-adherence, investigators will make a call to 
the specific study participants to find out reasons for non-adherence and to assess 
outcome. 
 
Intervention group: 
This group will be recruited after the sample size for the control cohort has been 
reached. Caregivers will be identified weekly at the Pediatric Oncology Unit, during the 
last two months of treatment. Study information will be provided, and informed consent 
will be requested. Upon approval, caregivers will be subjected to a pre-test (see 
attachment) to measure their knowledge of the various survivorship topics that will be 
addressed in the educational material. After treatment completion, all caregivers will 
fill in an interim-test (see attachment). The assessment will be performed by a 
researcher, who will fill the assessment form according to the participant’s answers. 
Six months after treatment completion, caregivers will fill in a combined post-test and 
satisfaction questionnaire (see attachment) during a scheduled follow-up appointment 
at the outpatient clinic. In case the survivor and caregivers do not appear at the six 
months follow-up appointment, they will be called to reschedule their appointment. If 
they then will still be unable to attend the follow-up clinic, caregivers will be requested 
for a phone interview to assess knowledge and satisfaction.  
Implementation measures (percentage of new survivors having received education, 
percentage of survivors attending follow-up clinic, and percentage of these survivors 
who bring their Survivorship Card) will be evaluated weekly.  
Follow-up adherence will be prospectively evaluated by checking in the medical 
records at the end of every weekly clinic day, whether families were present at their 
scheduled hospital appointment at 3, 6, 12, 18 and 24 months after treatment 
completion or not.  
 
Data collection: 
Available data about patient and treatment characteristics will be collected: 
-From the medical records: 
o Patient characteristics: Hospital IP number, sex, date of birth, enrollment in NHIF 
during/after treatment, comorbidities (HIV, sickle cell disease, other chronic 
diseases) 
o Disease characteristics: Age at diagnosis, year of diagnosis, diagnosis 
o Treatment characteristics: Date of planned completion of treatment, type of 
treatment, (surgery/chemo/radiotherapy), type and location of surgery, type and 
dosage of chemotherapy, type and dosage of radiotherapy 
-Using a questionnaire during a Phone interview in case of non-adherence: 

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o Reasons for non-adherence: Medical reasons (death, cause of death, relapse, 
date of death/relapse) or other reasons (time, finances, no added value, no 
reason). 
o Intention to revisit follow-up clinic. 
 
Additional data will be obtained through the data collection tools 
a) Participant background information: 
o Caregiver characteristics: Interviewed caregiver, date of interview, primary 
caregiver, age of interviewed caregiver, education of caregivers, occupation of 
caregivers, marital status biological parents, number of siblings, number of 
household members, residence (county), regular income, distance to MTRH, 
travel time to MTRH 
 
b) Follow-up adherence 
Follow-up adherence will be evaluated by checking in the medical records whether 
families attended to their scheduled hospital appointments at 6, 12, 18 and 24 months 
after treatment completion or not. Missed appointments will be counted.  
Survivors will be considered non-adherent when they did not appear for their 
scheduled visit (within 4 weeks before or after the scheduled visit) 
Survivors will be considered lost to follow-up when an appointment has been missed, 
and they have not revisited the follow-up clinic since the missed appointment for more 
than six months.    
c) Knowledge 
Caregivers: 
o Diagnosis and treatment (type of cancer, name of cancer, specific name 
of cancer, location of cancer, treatment of cancer, surgery and type of 
surgery, chemotherapy and type of chemotherapy, radiotherapy and 
location of radiotherapy) 
o Late effects and follow-up care (why to come for follow-up, how frequent 
to come for follow-up, where to go for follow-up, late effects general, late 
effects specific, late effects risk) 
 
d) Satisfaction 
o Acceptability (e.g. helpful information, would recommend tool to others) 
o Feasibility (e.g. easy to understand, interesting for all ages, usage of the 
tool when having health problems) 
o Potential effectiveness (e.g. new information, know when to seek help 
from healthcare provider) 
 
 
e) Implementation  

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o Reach (percentage new survivors having received the booklet, video and 
survivorship card) 
o Adoption (percentage of survivorship card taken to clinic appointment) 
o Implementation (At 6 months: Symptoms reported as a result of video / 
booklet / survivorship card information) 
o Maintenance (At 6 months: Recommendations for future implementation, 
any missed topics) 
 
Study intervention materials (video, information booklet, survivorship card) and data 
collection tools will be available in English and Kiswahili. The tools will be developed 
in English, forward-translated into Kiswahili by a translator, and backward-translated 
to English by a native Kiswahili speaker to check for inaccurate or inappropriate 
translations.  
 

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2) SURVIVORSHIP FOLLOW-UP PROGRAM 
 
The purpose of this program is to assess whether implementation of a Survivorship 
Follow-Up Program results in enhanced knowledge about survivorship of healthcare 
providers taking care of children with cancer at MTRH, and increased detection and 
management of physical and psychosocial late effects among childhood cancer 
survivors. Training about childhood cancer survivorship will be provided to an 
estimated 30 healthcare providers within the first two months from approval of study.  
Data from the medical records of childhood cancer survivors attending the follow-up 
clinic will be extracted from the start of the study.  
Inclusion Criteria: 
- Healthcare providers:                                                                                                                          
Thirty healthcare providers (the total pediatric oncology workforce comprises of an 
estimated 30 staff members) working in the Pediatric Oncology Unit at MTRH: 
Pediatric Oncologists, Fellows, Registrar, Medical Officers, Clinical officers, Nurses, 
Patient Navigators, Child life specialists. 
- Childhood cancer survivors  
The medical records of children visiting the follow-up clinic with: 1) Diagnosis of 
childhood cancer 2) Successfully having completed childhood cancer treatment 3) No 
treatment failure (abandonment of treatment, progressive or relapsed disease) 
 
 
Figure 2: Healthcare providers follow-up program timeline 
 
 
 
 
 
 
 
 
 
 
 
 

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Components of Survivorship Follow-Up Program: 
 
a) Training of healthcare providers about childhood cancer survivorship: 
All 30 healthcare providers involved in the care of children with cancer at MTRH are 
invited to attend a presentation about survivorship care (physical late effects, 
psychosocial late effects, stigmatization, social reintegration). The Survivorship Card 
and the Follow-up Form will be introduced. In addition, practical instructions will be 
provided about using the new survivorship tools. The presentation will take 2 hours. 
Investigators aim that 10 participants will be present at every training session, with a 
minimum of 5 participants per session. 
b) Follow-up Form usage at follow-up outpatient clinic: 
The Follow-up Form will include questions referring to symptoms specific for certain 
late effects. The first part of the follow-up form will focus on detecting relapses. Specific 
questions will be included per subcategory: hematological malignancies, solid tumors 
or central nervous system (CNS) tumors (such as a question referring to 
cardiomyopathy after anthracycline treatment for survivors of hematological 
diagnoses).27 In addition, the form addresses general health issues such as fatigue, 
pain, dental hygiene, neurocognitive (concentration/memory), and psychosocial issues 
(in school or in the community). In case a symptom will be identified, subsequent 
investigations or referrals are recommended according to international guidelines. 
Considering the high financial burden of screening (for example close to 500 cardiac 
echo’s to avert one case of heart failure), investigators have chosen for a well-
structured symptom-based approach, focusing on a thorough history and physical 
examination.28 Every follow-up visit, a new follow-up form will be included in the 
medical record, enabling the healthcare provider to easily address new symptoms, and 
keep track of previously identified health problems.  
c) Effects identified 
Participant recruitment: 
o Healthcare providers:                                                                                                                      
Training about childhood cancer survivorship will be provided to an estimated 30 
healthcare providers within the first two months from start of study. Investigators will 
reach out to all pediatric oncology staff members, according to information from the 
department leadership. Informed consent will be requested before the presentation. 
After approval has been given, a knowledge pre-test will be provided at the beginning 
of the training session. The test should be self-completed before start of the training 
session. After the session investigators will share a knowledge post-test to evaluate 
knowledge. The test should be self-completed before they leave the training venue.  
At six months after completing the training, a late knowledge test and satisfaction 
questionnaire will be shared with healthcare providers who handle the follow-up form 
in follow-up clinic.   
Data (reported symptoms and clinician usage) in the Follow-up Forms, included in the 
medical records of childhood cancer survivors attending the follow-up clinic, will be 
weekly extracted from the start of the study.  
 

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o Medical records of childhood cancer survivors: 
Medical records of all childhood cancer survivors attending follow-up clinic will be 
evaluated. Evaluation of these medical records will start from the moment all the 
healthcare workers have been educated for a period of 1 year. 
Data collection: 
Available data about patient and treatment characteristics will be collected from the 
medical records (follow-up forms): 
a) Survivor background information 
o Patient characteristics: Hospital IP number, sex, date of birth, residence 
(county), distance to MTRH, travel time to MTRH, enrollment in NHIF 
during/after treatment, comorbidities (HIV, sickle cell disease, other chronic 
diseases) 
o Disease characteristics: Age at diagnosis, year of diagnosis, diagnosis 
o Treatment characteristics: Date of planned completion of treatment, type of 
treatment (surgery/chemo/radiotherapy), type and location of surgery, type 
and dosage of chemotherapy, type and dosage of radiotherapy 
 
Additional data will be obtained through the data collection tools. 
a) Healthcare providers knowledge assessment: 
o Demographics: sex, age, cadre (function) 
o Knowledge level: years practicing in pediatric oncology, survivors seen 
per week, survivorship care training, confidence managing late effects 
o Late effects and follow-up care (why to come for follow-up, how frequent 
to come for follow-up, where to go for follow-up, late effects risk, late 
effects general, late effects specific, chemotherapy associated late 
effects, surgery associated late effects, radiotherapy associated late 
effects) 
o Diagnosis and treatment (surgery history, type of surgery, chemotherapy 
history, type of chemotherapy, radiotherapy history, location of 
radiotherapy) 
b) Reported late effects Follow-up Form: 
o Physical outcomes: relapsed disease, subsequent neoplasm, subfertility, 
heart failure, hypothalamic-pituitary dysfunction (hormonal dysfunction), 
motor problems, hearing problems, disfigurements, visual problems, 
reduced joint mobility, renal insufficiency, osteonecrosis, myocardial 
infarction, pulmonary dysfunction, seizures, posterior fossa syndrome 
(speech loss, unsteady gait, reduced spontaneous movements, 
emotional lability), stroke (hemorrhagic or ischemic), temperature 
dysregulation, male sexual dysfunction, under / overweight 
o Psychosocial and neurocognitive outcomes 
o Physical aspects of quality of life: fatigue, sleep, challenges 
exercise / chores / physical labor, challenges personal care 

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o Psychosocial aspects of quality of life: anxiety / worrying, sadness, 
anger/ trouble getting along with others, avoidance / exclusion / 
bullying 
o Neurocognitive aspects of quality of life: memory / concentration 
problems, educational problems (miss school because of 
condition, trouble keeping up with homework) 
 
d) Satisfaction 
A questionnaire containing the following parts will be used to assess satisfaction of 
healthcare workers  
o Acceptability (relevant potential late effect symptoms, addresses late effects 
comprehensively, like using the follow-up form, recommend using the follow-up 
form) 
o Feasibility (easy to use, fast to use in practice, makes documentation easier, 
has become part of my routine, would like to continue using the follow-up form) 
o Potential effectiveness (has helped to identify late effects, has helped to 
address late effects, has helped to refer survivors, reminds healthcare providers 
of things that otherwise would have forgotten, has improved follow-up care) 
e) Implementation 
o Reach (percentage of new survivors, having received the follow-up form in 
clinic) 
o Adoption (percentage follow-up forms used by clinician; percentage follow-up 
forms completely filled by clinician) 
o Implementation (investigations done as a result of reported symptoms, referrals 
done as a result of reported symptoms, additional investigations done, not as 
recommended by the form, referrals done, not as recommended by the form) 
o Maintenance (how did implementation go in practice, and any ideas on how to 
maintain the program and improve for future implementation?) 
 
 

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3) SURVIVORSHIP SUPPORT PROGRAM 
The purpose of this part of the study is to explore whether implementation of a 
WhatsApp support group increases social support among caretakers of childhood 
cancer survivors. Acceptability and feasibility of the WhatsApp support group will be 
explored. The study also explores willingness to continue participating and moderating 
future support groups.  
Inclusion criteria 
Caregivers of children with: 1) Diagnosis of childhood cancer 2) No treatment failure 
(abandonment of treatment, progressive or relapsed disease) 3) Completed 
childhood cancer treatment 4) WhatsApp access through personal phone, or 
someone’s phone in the social network 
 
Figure 3: Support Program timeline 
 
 
Components of Survivorship Support Program: 
A maximum of three WhatsApp support groups will be formed for caregivers of 
childhood cancer survivors. Caretakers of 10-15 childhood cancer survivors will 
participate in each WhatsApp support group.  The involved researchers will be the 
moderators of these groups initially. This platform will be used for: a) educational 
purposes and b) sharing experiences among parents and survivors themselves. The 
educational content will cover six themes (‘hospital, family, selfcare, community, wrap-
up, recap’) during six consequent months. Participants will introduce themselves within 
the first week of the group forming. In the following weeks, the topics ‘hospital, family, 
selfcare, community’ will be discussed, finishing with a wrap up during the last month. 
Every theme will be split among four weekly sessions (for example the topic ‘family’ 
will be split into one session on siblings, one session on partner, one session on 
extended family and one session on challenges within the family). Participants will be 
encouraged to respond to the raised topics, share their experiences and also ask 
questions. There should also be the possibility to raise questions or concerns unrelated 
to the weekly topic. A recap will follow three months after the last session. After 
finalizing the recap session of the educational course, caretakers will be asked to 
evaluate the WhatsApp the support group through a questionnaire.  
 
 
 

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Participant recruitment: 
o Caregivers will be recruited, and the informed consent procedure will be 
performed, similarly to the caregivers in the Educational Program in the last two 
months of receiving cancer treatment. Caretakers should be able to prove they can 
access a mobile phone device with WhatsApp; preferably their own device, or a 
device of someone in their personal network that they can frequently access. After 
start of the study, recruitment will take place for a duration of three months. Each 
group will have caretakers of 10-15 childhood cancer survivors.  All participants of 
the same WhatsApp group will start at the same time, and no new members will be 
added to the group after start of the first session. Implementation measures 
(percentage of eligible participants with WhatsApp access, percentage participants 
active at every weekly session, percentage of participants actively contributing to 
the discussion, percentage of participants prompting questions irrespective of the 
weekly topic, topics discussed by moderators, topics discussed by caregivers, time 
to respond to questions raised by moderators) will be evaluated weekly. After 
finalizing the recap session of the educational course, the WhatsApp support 
groups will be evaluated by the caretakers through a questionnaire. Participants of 
the support group will be subjected to the questionnaire at their next visit to the 
follow-up clinic after the recap session. In case caregivers do not attend the follow-
up clinic, they will be phone called to encourage them to come for their next follow-
up visit. In case they are unable to visit, their satisfaction will be evaluated through 
a phone call. 
Data collection: 
Available data about patient and treatment characteristics will be collected from the 
medical records.  
a) Survivor background information 
o Patient characteristics: Hospital IP number, sex, date of birth, residence 
(county), distance to MTRH, travel time to MTRH, enrollment in NHIF 
during/after treatment, comorbidities (HIV, sickle cell disease, other chronic 
diseases) 
o Disease characteristics: Age at diagnosis, year of diagnosis, diagnosis 
o Treatment characteristics: Date of planned completion of treatment, type of 
treatment (surgery/chemo/radiotherapy), type and location of surgery, type 
and dosage of chemotherapy, type and dosage of radiotherapy 
 
Additional data will be obtained through the data collection tools. 
a) Participant background information: 
o Caregiver characteristics: Interviewed caregiver, date of interview, primary 
caregiver, age of interviewed caregiver, education of caregivers, occupation of 
caregivers, marital status biological parents, number of siblings, number of 
household members, residence (county), regular income, distance to MTRH, 
travel time to MTRH 
 
 
 
 

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b) Satisfaction 
o Acceptability (quality information, friendly / safe environment, like participating 
in the support group, would recommend the support group) 
o Feasibility (easy to use, can be used by caregivers of all ages, has become part 
of my routine, can use the support group when I want to, can use the support 
group how I want to) 
o Potential effectiveness (has taught participant new information, has connected 
participant to like-minded people, has allowed participant to share experiences, 
has given participant social support) 
c) Implementation  
o Reach (percentage of eligible participants with WhatsApp access, percentage 
participants active at every weekly session) 
o Adoption (percentage of participants actively contributing to the discussion, 
percentage of participants prompting questions irrespective of the weekly topic) 
o Implementation (topics discussed by moderators, topics discussed by 
caregivers, time to respond to questions raised by moderators, implementation 
costs) 
o Maintenance (how did implementation go in practice, and any ideas on how to 
maintain the program and improve for future implementation?) 
d) Content 
o Rate the monthly topics on a scale 1 to 10 (introduction, hospital, family, 
selfcare, community, wrap up, recap) 
o Relevant topics missed 
o Rate importance of aspects of WhatsApp group (meeting other caregivers, 
having a place to express feelings, hearing other caregivers’ experiences, 
getting advice on how to cope with condition / treatment / stress and anxiety, 
family and relationship issues, self-care, community issues, school issues, work 
issues, support from other caregivers  
o Evaluation (recommend the support program, stay in touch with other 
participants, would participant like to continue joining, would participant be 
willing to moderate, recommendations) 
Data management and analysis 
Data will be entered on paper data collection forms, subsequently transferred to an 
online data storage, or will be entered directly online in Castor EDC, a secured cloud 
data storage system designed for research purposes. Paper data collection forms will 
be stored in a cabinet in a research office. A limited number of pediatric oncology 
department staff members have access to this office. Analyses will be performed in 
IBM SPSS or in R Studio.  
Univariate analysis will be used for descriptive data (percentages, frequencies), 
dichotomous data will be analyzed with Chi-Square testing or logistic regression, and 
continuous data will be analyzed with t-testing or linear regression. Progression in 
levels of knowledge of caregivers and healthcare providers between the first, second 
and third assessment will be calculated. Levels of knowledge will be compared 
between the educated group and non-educated group at six months after treatment 
completion. Investigators will also compare the treatment adherence between the 
educated group and non-educated group at 6,12,18 and 24 months after treatment 

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completion. Multiple regression analyses will be performed to identify associated 
factors with follow-up non-adherence and knowledge uptake.  
ETHICAL CONSIDERATIONS 
 
Participants who meet the inclusion criteria will be given a written informed consent 
(see attachments) to sign. The informed consent will be written in both English and 
Kiswahili. The participants will be asked to choose which language they are most 
proficient in and then they will be given to read and sign if they consent, or the form 
will be read out loud by the researcher. There will always be a researcher present, for 
clarification of the study content and to address questions.  
 
STUDY IMPLICATIONS 
This study aims to improve survivorship care in Kenya through a holistic approach. 
Investigators aim to improve follow-up adherence of survivors. Investigators also aim 
to set an example for other paediatric oncology centres in low and middle-income 
settings, by showing that well-informed survivors may be at a lower risk of follow-up 
non-adherence. In addition, investigators aim to build a case for implementation of 
context-sensitive tools, based on international guidelines, to enable healthcare 
providers to provide care in a comprehensive but feasible way. At last, investigators 
acknowledge the importance of peer support, and aim to address the psychosocial 
needs of caregivers of childhood cancer survivors. Facilitating network building 
between survivor families, may help to empower them to advocate for their own specific 
needs in future.  
 

18 
 
REFERENCES 
 
1. 
Uittenboogaard A, Njuguna F, Mostert S, et al. Outcomes of Wilms tumor treatment in 
western Kenya. Pediatr Blood Cancer. 2021:e29503. 
2. 
Langat S, Njuguna F, Olbara G, et al. Influence of health-insurance on treatment outcome of 
childhood cancer in Western Kenya. Support Care Cancer. 2023;31(8):467. 
3. 
Gibson TM, Mostoufi-Moab S, Stratton KL, et al. Temporal patterns in the risk of chronic 
health conditions in survivors of childhood cancer diagnosed 1970–99: a report from the 
Childhood Cancer Survivor Study cohort. Lancet Oncol. 2018;19(12):1590-1601. 
4. 
Streefkerk N, Tissing WJE, Korevaar JC, et al. A detailed insight in the high risks of 
hospitalizations in long-term childhood cancer survivors-A Dutch LATER linkage study. PLoS 
One. 2020;15(5):e0232708. 
5. 
Gurney JG, Krull KR, Kadan-Lottick N, et al. Social outcomes in the Childhood Cancer Survivor 
Study cohort. J Clin Oncol. 2009;27(14):2390-2395. 
6. 
Nipp RD, Kirchhoff AC, Fair D, et al. Financial burden in survivors of childhood cancer: a 
report from the Childhood Cancer Survivor Study. J Clin Oncol. 2017;35(30):3474-3481. 
7. 
Kremer LC, Mulder RL, Oeffinger KC, et al. A worldwide collaboration to harmonize guidelines 
for the long-term follow-up of childhood and young adult cancer survivors: a report from the 
International Late Effects of Childhood Cancer Guideline Harmonization Group. Pediatr Blood 
Cancer. 2013;60(4):543-549. 
8. 
Landier W, Skinner R, Wallace WH, et al. Surveillance for Late Effects in Childhood Cancer 
Survivors. J Clin Oncol. 2018;36(21):2216-2222. 
9. 
Signorelli C, Wakefield CE, Fardell JE, et al. The impact of long-term follow-up care for 
childhood cancer survivors: A systematic review. Crit Rev Oncol Hematol. 2017;114:131-138. 
10. 
van Kalsbeek RJ, Mulder RL, Haupt R, et al. The PanCareFollowUp Care Intervention: A 
European harmonised approach to person-centred guideline-based survivorship care after 
childhood, adolescent and young adult cancer. Eur J Cancer. 2022;162:34-44. 
11. 
Zyl AV, Rogers PC, Kruger M. Current childhood cancer survivor long-term follow-up practices 
in South Africa. 2020. 
12. 
İncesoy Özdemİr S, Taçyıldız N, Varan A, et al. Cross-sectional study: long term follow-up care 
for pediatric cancer survivors in a developing country, Turkey: current status, challenges, and 
future perspectives. Turk J Med Sci. 2020;50(8):1916-1921. 
13. 
Afungchwi GM, Hesseling P, van Elsland SL, Kouya F, Kruger M. Destitution, treatment 
adherence and survival of children with Burkitt lymphoma in a twinning programme in 
Northwest Cameroon. Pediatr Blood Cancer. 2019;66(12):e27946. 
14. 
Klosky JL, Cash DK, Buscemi J, et al. Factors influencing long-term follow-up clinic attendance 
among survivors of childhood cancer. J Cancer Surviv. 2008;2(4):225-232. 
15. 
Landier W, Chen Y, Namdar G, et al. Impact of Tailored Education on Awareness of Personal 
Risk for Therapy-Related Complications Among Childhood Cancer Survivors. J Clin Oncol. 
2015;33(33):3887-3893. 
16. 
Ampofo AG, Gyamfuaah SA, Opoku NS, Owusu SO, Ibitoye MB. A pilot study of a video-based 
educational intervention and knowledge of cervical cancer among senior high school 
students in Ghana: A before-after study. Journal of Cancer Policy. 2020;24:100220. 
17. 
Lemmen J, Njuguna F, Verhulst S, et al. Late effects of childhood cancer survivors in Africa: A 
scoping review. Crit Rev Oncol Hematol. 2023;185:103981. 
18. 
Watt MH, Suneja G, Zimba C, et al. Cancer-related stigma in Malawi: narratives of cancer 
survivors. JCO Glob Oncol. 2023;9:e2200307. 
19. 
Lemmen J MN, Njuguna F, Kaspers G, Mostert S. Late Effects of Therapy, Stigmatization and 
Social Reintegration following Childhood Cancer Survival in Kenya: A Case Report. Annals of 
Health Research. 2022;8(4):315-322. 
20. 
Kim MA, Yi J. Life after cancer: how does public stigma increase psychological distress of 
childhood cancer survivors? Int J Nurs Stud. 2014;51(12):1605-1614. 

19 
 
21. 
Rabin C. Cancer-related self-disclosure in the workplace/school by adolescent and young 
adult cancer survivors. J Adolesc Young Adult Oncol. 2020;9(4):528-533. 
22. 
Kent EE, Smith AW, Keegan TH, et al. Talking About Cancer and Meeting Peer Survivors: 
Social Information Needs of Adolescents and Young Adults Diagnosed with Cancer. J Adolesc 
Young Adult Oncol. 2013;2(2):44-52. 
23. 
Liptak C, Brinkman T, Bronson A, et al. A social program for adolescent and young adult 
survivors of pediatric brain tumors: The power of a shared medical experience. J Psychosoc 
Oncol. 2016;34(6):493-511. 
24. 
Yi HJ, Nam SI. The effect of advocacy for overcoming stigma on posttraumatic growth: 
focusing on childhood cancer survivors. Soc Work Health Care. 2017;56(9):840-854. 
25. 
Rossell N, Olarte-Sierra MF, Challinor J. Survivors of childhood cancer in Latin America: Role 
of foundations and peer groups in the lack of transition processes to adult long-term follow-
up. Cancer reports (Hoboken, NJ). 2021(101747728):e1474. 
26. 
Nair M, Parukkutty K, Kommadath S. Effect of a new social support program by voluntary 
organization in pediatric oncology department in a developing country. Pediatric hematology 
and oncology. 2014;31(3):212-216. 
27. 
van Kalsbeek RJ, Hudson MM, Mulder RL, et al. A joint international consensus statement for 
measuring quality of survival for patients with childhood cancer. Nature Medicine. 
2023;29(6):1340-1348. 
28. 
Ehrhardt MJ, Ward ZJ, Liu Q, et al. Cost-Effectiveness of the International Late Effects of 
Childhood Cancer Guideline Harmonization Group Screening Guidelines to Prevent Heart 
Failure in Survivors of Childhood Cancer. J Clin Oncol. 2020;38(33):3851-3862. 
-  
Appendix: Budget 
 
Survivorship Intervention Program Budget 
Item 
Cost (€  )         
Research Nurse 
14,750 
Support group meetings/Association registration 
16,701 
Educational materials 
314 
Stationery 
464 
Communication 
1276 
IREC fee 
400 
NACOSTI license 
80 
Total 
33,985