Study to Education Childhood Cancer Survivors About Survivorship Care

Childhood Cancer Clinical Trial

— SPEAC  

Official title:

Childhood Cancer Survivor Program to Empower Action in Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742481
• Other study ID #: K23CA124451
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: May 10, 2016
• Start date: August 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2016
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Behavioral:
• Education and empowerment
Three group sessions delivered once per week over three weeks. Education on late effects of treatment, survivorship care, how to request medical records, and role playing on how to talk to a provider about childhood cancer health risks

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scheduling a survivorship visit	Patient report of setting up an appointment at one of the three long-term follow-up clinics in Chicago or setting up an appointment with a physician who is working on a survivorship plan with the patient.	6 months	No
Secondary	requesting and obtaining medical records from pediatric oncology	Filling out a medical record request form and submitting the form to the pediatric oncology hospital. This may be done by the survivor or the physician.	6 months	No