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NCT Number: NCT06680687

Survivorship Intervention Program in Western Kenya: 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.

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Key information

Conditions

Pediatric Cancer Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Neoplasms Patient Acceptance of Health Care Patient Compliance Survivorship Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational Program (video, information booklet, Survivorship Card)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Intentions to revisit the follow-up clinic (questionnaire)

    Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months.

    Intentions to revisit the follow-up clinic (yes/no, what can hospital do to support participant in adhering to follow-up visit) will be explored through a phone call.

Secondary outcomes

  1. Caregiver knowledge (questionnaire)

    Time frame: 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.

  2. Healthcare provider knowledge (questionnaire)

    Time frame: 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.

  3. Follow-Up Form documented late effects prevalence

    Time frame: 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.

  4. Reach caregivers (Implementation measures data collection tool)

    Time frame: 24 months: weekly

    Percentage eligible caregivers having received the booklet, video and Survivorship Card, characteristics of caregivers included in the study

  5. Reach healthcare providers (Implementation measures data collection tool)

    Time frame: 12 months: weekly.

    Percentage eligible healthcare providers trained, Characteristics of healthcare providers included in the study

  6. Adoption caregivers (Implementation measures data collection tool)

    Time frame: 24 months: at 3, 6, 9, 12, 18 and 24 months

    Percentage study participants taking the Survivorship Card to clinic appointment

  7. Adoption healthcare providers (Implementation measures data collection tool)

    Time frame: 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

  8. Caregiver satisfaction (questionnaire)

    Time frame: 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).

  9. Healthcare provider satisfaction (questionnaire)

    Time frame: 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).

  10. Caregiver recommendations

    Time frame: At 6 months after receiving the educational intervention

    Open question exploring recommendations to improve educational intervention

  11. Healthcare provider recommendations

    Time frame: At 6 months after receiving the healthcare provider training

    Open question exploring recommendations to improve the Follow-Up Form

Study contacts

Contact information is provided by the study sponsor or research team.

Jesse Lemmen, MSc

CONTACT

[email protected]

+31 649892448

Susan Mageto, MPharm

CONTACT

[email protected]

+254 715823203

Sponsors and collaborators

Lead sponsor

Moi University

Other

Collaborators

  • Amsterdam UMC
  • Princess Maxima Center for Pediatric Oncology

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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