Clinical trial NCT01742481: Study to Education Childhood Cancer Survivors About Survivorship Care
Official title: Childhood Cancer Survivor Program to Empower Action in Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: childhood cancer survivors
long-term follow-up care
health communication
ethnic/racial minorities
longterm survivors
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with any childhood cancer excluding CNS prior to age of 18 years
* Completed treatment at least 5 years ago
* Currently cancer free and 18 years or older
* Self-identifies as African American, Hispanic/Latino, or White

Exclusion Criteria:

* Ever seen for risk-based follow-up care as an adult (18 or older)

Primary outcomes:
measure: scheduling a survivorship visit
timeFrame: 6 months
Secondary outcomes:
measure: requesting and obtaining medical records from pediatric oncology
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References: