Pediatric CancerNCT06680687
Survivorship Intervention Program in Western Kenya: Study Protocol
A study testing Educational Program (video, information booklet, Survivorship Card) and Follow-Up Program (form and healthcare provider training) in people with Pediatric Cancer and Survivorship, run by Moi University at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Cancer, Survivorship
- What is being tested?
- Educational Program (video, information booklet, Survivorship Card) and Follow-Up Program (form and healthcare provider training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteKenya
- Study dates
- Nov 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site
Moi Teaching and Referral Hospital
Eldoret, Rift Valley, P.O. Box 3-30100
Susan Mageto, MPharm, +254 715823203, susanmageto.mageto@gmail.com
Festus Njuguna, MD, PhD, +254 787723677, muigaifes2000@yahoo.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Pediatric Cancer, Survivorship
- Being tested
- Educational Program (video, information booklet, Survivorship Card), Follow-Up Program (form and healthcare provider training)
- Keywords
- Aftercare, Health Education, Patient Compliance, Surveillance
- Medical subject headings
- Neoplasms, Health Education, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Program (video, information booklet, Survivorship Card)Behavioural
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.
Follow-Up Program (form and healthcare provider training)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| "Usual Care" | No intervention | 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" | Experimental | 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. Receives: Behavioral: Educational Program (video, information booklet, Survivorship Card) |
| "Follow-Up Forms implementation" | Other | 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. Receives: Behavioral: Follow-Up Program (form and healthcare provider training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of non-adherent study participants
When survivors do not appear at a scheduled visit within four weeks before or after the scheduled date.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months: at 3, 6, 9, 12, 18 and 24 months.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 24 months: weekly
Reach healthcare providers (Implementation measures data collection tool)
Percentage eligible healthcare providers trained, Characteristics of healthcare providers included in the study
Measured: 12 months: weekly.
Adoption caregivers (Implementation measures data collection tool)
Percentage study participants taking the Survivorship Card to clinic appointment
Measured: 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
Measured: 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).
Measured: 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).
Measured: At 6 months after receiving the healthcare provider training
Caregiver recommendations
Open question exploring recommendations to improve educational intervention
Measured: At 6 months after receiving the educational intervention
Healthcare provider recommendations
Open question exploring recommendations to improve the Follow-Up Form
Measured: At 6 months after receiving the healthcare provider training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moi University
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Maxima Center for Pediatric Oncology, Amsterdam UMC
- Responsible party
- Sponsor
- Investigators
- Festus Njuguna, MD, PhD, Principal investigator, Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680687
- Sponsor's protocol ID
- 0004807
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Lemmen J, Mageto S, Vik T, Olbara G, Kaspers G, Njuguna F. Non-randomised prospective clinical trial to improve follow-up adherence, survivorship knowledge and late effects documentation at a childhood cancer clinic in Western Kenya: a study protocol. BMJ Open. 2025 Jun 10;15(6):e096741. doi: 10.1136/bmjopen-2024-096741.
PubMed 40499965
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06680687
- Acronym / sponsor ID
- 0004807
- Conditions
- Pediatric Cancer, Survivorship
- Keywords
- Aftercare, Health Education, Patient Compliance, Surveillance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Moi UniversityUniversity, hospital or other
- Collaborators
- Princess Maxima Center for Pediatric Oncology, Amsterdam UMC
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| "Usual Care" | No intervention | –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" | Experimental | Behavioral: Educational Program (video, information booklet, Survivorship Card)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. |
| "Follow-Up Forms implementation" | Other | Behavioral: Follow-Up Program (form and healthcare provider training)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational 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. | Behavioural | "Educational Intervention" |
| Follow-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. | Behavioural | "Follow-Up Forms implementation" |
Primary outcome
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.
11 secondary outcomes
Caregiver knowledge (questionnaire)
Time frame: Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment
Healthcare provider knowledge (questionnaire)
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
Time frame: 12 months: weekly.
Reach caregivers (Implementation measures data collection tool)
Time frame: 24 months: weekly
Reach healthcare providers (Implementation measures data collection tool)
Time frame: 12 months: weekly.
Adoption caregivers (Implementation measures data collection tool)
Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months
Adoption healthcare providers (Implementation measures data collection tool)
Time frame: 12 months: weekly.
Caregiver satisfaction (questionnaire)
Time frame: At 6 months after receiving the educational intervention
Healthcare provider satisfaction (questionnaire)
Time frame: At 6 months after receiving the healthcare provider training
Caregiver recommendations
Time frame: At 6 months after receiving the educational intervention
Healthcare provider recommendations
Time frame: At 6 months after receiving the healthcare provider training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 40499965Lemmen J, Mageto S, Vik T, Olbara G, Kaspers G, Njuguna F. Non-randomised prospective clinical trial to improve follow-up adherence, survivorship knowledge and late effects documentation at a childhood cancer clinic in Western Kenya: a study protocol. BMJ Open. 2025 Jun 10;15(6):e096741. doi: 10.1136/bmjopen-2024-096741.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Festus Njuguna, MD, PhD principal investigator
Moi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program (video, information booklet, Survivorship Card) and Follow-Up Program (form and healthcare provider training) in people with Pediatric Cancer and Survivorship, run by Moi University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Mageto, MPharm (+254 715823203, susanmageto.mageto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of non-adherent study participants (time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06680687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.