Childhood Cancer Clinical Trial
Official title:
Childhood Cancer Survivor Program to Empower Action in Care
The proposed study is part of a career development award. The first two phases of research involve collaborating with adult survivors of childhood cancer representing both sexes and three ethnic/racial groups (African American, Hispanic, and White). THe collaboration will focus upon developing educational material that is helpful in teaching survivors about health risks related to cancer treatments and about survivorship care. The third phase is a randomized controlled trial that will randomly (like a flip of coin)place survivors into one of two groups. One group will meet in -person with a group leader three times, once each week over three weeks. The other group will receive an information packet that contains websites, books, and resources similar to content provided in-person within a group format to the other group. The goal is to help adult survivors get involved in specialized healthcare so they can remain healthy. This involves getting a copy of their medical record to understand what treatments they received and working with health providers to get an individualized survivorship care plan.
The proposed study includes three aims: intervention development using focus groups,
intervention refinement based upon a pre-pilot, and a randomized controlled pilot study of
the final intervention. All participants are adult survivors of childhood cancer, males and
females from three ethnic backgrounds (Black, Hispanic, White). The randomized control pilot
is designed to assess the acceptibility/feasibility of a community-based intervention to
engage childhood cancer survivors more actively in cancer follow-up care. Pilot data on
outcome measures will provide data parameters (e.g. means and variances of groups) for
accurate power analyses and sample size calculation to support a subsequent efficacy trial.
Relevance: This project is a critical initial step towards addressing systemic problems in
transition of care and has the potential to decrease morbidity of adult childhood cancer
survivors.
Outcomes include: knowledge of late effects and follow-up care, uncertainty related to 1)
relapse, 2) secondary cancers, and 3) late effects, perceived efficacy to communicate with
physician, access to childhood medical records, self-efficacy to obtain medical records, and
the number of completed health care visits at a six month follow-up interview.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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