Survivorship Intervention Program in Western Kenya: Study Protocol

Sponsor
Moi University
Study ID
NCT06680687
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Pediatric Cancer
  • Survivorship

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Nov 8, 2024
Start date
Nov 30, 2024
Status verified
Nov 2024
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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), 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.
  • Experimental: "Educational Intervention"
    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.
  • 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.

Primary Outcome Measure

Percentage of non-adherent study participants [ Time Frame: 24 months: at 3, 6, 9, 12, 18 and 24 months. ]

Central Contacts

Related Studies