Survivorship Intervention Program in Western Kenya: Study Protocol

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:

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cancer; Survivorship
• Intervention / Treatment: Behavioral: Educational Program (video, information booklet, Survivorship Card); Behavioral: Follow-Up Program (form and healthcare provider training)

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 where they 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 they miss a scheduled appointment and 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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Mageto, MPharm; Phone Number: +254 715823203; Email: susanmageto.mageto@gmail.com
• Study Contact Backup: Name: Jesse Lemmen, MSc; Phone Number: +31 649892448; Email: jpm.lemmen@gmail.com

Study Locations

• Kenya
  • Rift Valley
    • Eldoret, Rift Valley, Kenya, P.O. Box 3-30100
      • Moi Teaching and Referral Hospital
      • Contact: Susan Mageto, MPharm; Phone Number: +254 715823203; Email: susanmageto.mageto@gmail.com
      • Contact: Festus Njuguna, MD, PhD; Phone Number: +254 787723677; Email: muigaifes2000@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: "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), they will complete a knowledge questionnaire and they 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. We estimate to have reached this number within four to six months based on recent survival rates.
Experimental: "Educational Intervention"; A similar procedure will apply to the "Educational Intervention" group (B). They will complete a knowledge assessment before receiving an educational intervention between T-2 and T0. To evaluate early and late knowledge uptake, they will complete a post-education knowledge assessment at T0 and a follow-up knowledge assessment at T6. Follow-up adherence will be evaluated at every three months for the first year and at every six months during the second year after treatment completion for both groups. Implementation measures will be captured starting at T3 until T24, together with a satisfaction questionnaire that will be administered at T6.	Behavioral: Educational Program (video, information booklet, Survivorship Card); 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 their 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.
Other: "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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of non-adherent study participants	Survivors will be considered non-adherent when they do not appear for their scheduled visit within four weeks before or after the scheduled visit.	24 months: at 3, 6, 9, 12, 18 and 24 months.
Percentage of participants lost to follow-up	Survivors will be considered lost to follow-up when they miss an appointment and do not revisit the follow-up clinic after their missed appointment for more than six months.	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.	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.	24 months: at 3, 6, 9, 12, 18 and 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 months: weekly.
Reach caregivers (Implementation measures data collection tool)	% Eligible caregivers having received the booklet, video and Survivorship Card, characteristics of caregivers included in the study	24 months: weekly
Reach healthcare providers (Implementation measures data collection tool)	% Eligible healthcare providers trained, Characteristics of healthcare providers included in the study	12 months: weekly.
Adoption caregivers (Implementation measures data collection tool)	% Study participants taking the Survivorship Card to their clinic appointment	24 months: at 3, 6, 9, 12, 18 and 24 months
Adoption healthcare providers (Implementation measures data collection tool)	% Eligible survivors having received the follow-up form in clinic; % Follow-up forms completely filled by clinician; Investigations and referrals done; Actions adhering to form instructions	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)	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)	At 6 months after receiving the healthcare provider training
Caregiver recommendations	Open question exploring recommendations to improve educational intervention	At 6 months after receiving the educational intervention
Healthcare provider recommendations	Open question exploring recommendations to improve the Follow-Up Form	At 6 months after receiving the healthcare provider training

Collaborators and Investigators

• Sponsor: Moi University
• Collaborators: Princess Maxima Center for Pediatric Oncology; Amsterdam UMC
• Investigators: Principal Investigator: Festus Njuguna, MD, PhD, Moi University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Health Education; Surveillance; Patient Compliance; Aftercare
• Other Study ID Numbers: 0004807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: No end date
• IPD Sharing Access Criteria: Any reasonable request to access underlying study data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No