Survivorship Intervention Program in Western Kenya: Study Protocol

NCT06680687 | Not Yet Recruiting

• 1 other identifier: 0004807
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

In this study protocol, the investigators described a survivorship intervention program that will be performed at a referral hospital in Western Kenya. This will be a non-randomized prospective cohort study with a sequential hybrid effectiveness - implementation design. The study comprises of an educational component for caregivers of childhood cancer survivors and a follow-up component targeting healthcare providers with survivorship training and implementation of a late effects documentation tool. Through these interventions the investigators aim to:

1. 1.increase follow-up adherence of childhood cancer survivors;
2. 2.increase caregivers' and healthcare providers' knowledge about childhood cancer diagnoses, treatment and the corresponding late effects risks;
3. 3.document late effects at a childhood cancer outpatient clinic;
4. 4.evaluate program implementation and satisfaction among recipients and providers.

Conditions

Pediatric Cancer; Survivorship

Keywords

Aftercare; Health Education; Patient Compliance; Surveillance

Outcome Measures

Primary Outcomes (4)

• Percentage of non-adherent study participants

  When survivors do not appear at a scheduled visit within four weeks before or after the scheduled date.

  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.

  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 Outcomes (11)

• Caregiver knowledge (questionnaire)

  Two months prior to survivor's treatment completion, assessed up to six months after completion of treatment

• Healthcare provider knowledge (questionnaire)

  From start healthcare provider training up to six months after the completion of the training session

• Follow-Up Form documented late effects prevalence

  12 months: weekly.

• Reach caregivers (Implementation measures data collection tool)

  24 months: weekly

• Reach healthcare providers (Implementation measures data collection tool)

  12 months: weekly.

Study Arms (3)

"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.

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.

Behavioral: Follow-Up Program (form and healthcare provider training)

Interventions

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.

"Educational Intervention"

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.

"Follow-Up Forms implementation"

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moi University: lead
• Princess Maxima Center for Pediatric Oncology: collaborator
• Amsterdam UMC: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Rift Valley, P.O. Box 3-30100, Kenya

Location

Related Publications (1)

• 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.

  PMID: 40499965 DERIVED

MeSH Terms

Conditions

Neoplasms; Health Education; Patient Compliance

Interventions

Videotape Recording; Metabolism

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Festus Njuguna, MD, PhD

  Moi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Mageto, MPharm

CONTACT

+254 715823203; susanmageto.mageto@gmail.com

Jesse Lemmen, MSc

CONTACT

+31 649892448; jpm.lemmen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 8, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: No end date
• Access Criteria: Any reasonable request to access underlying study data

Locations

KE (1)