Study to Education Childhood Cancer Survivors About Survivorship Care (SPEAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Lisa Sharp, University of Illinois
ClinicalTrials.gov Identifier:
NCT01742481
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Childhood Cancer
Behavioral: Education and empowerment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Childhood Cancer Survivor Program to Empower Action in Care

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • scheduling a survivorship visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • requesting and obtaining medical records from pediatric oncology [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: November 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Education and empowerment program
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
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
Placebo Comparator: self-guided empowerment and education
participants have information packet but receive no individualized support or assistance

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742481

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Dr. Lisa Sharp, Principal Investigator, University of Illinois
ClinicalTrials.gov Identifier: NCT01742481     History of Changes
Other Study ID Numbers: K23CA124451
Study First Received: December 3, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
childhood cancer survivors
long-term follow-up care
health communication
ethnic/racial minorities
longterm survivors

ClinicalTrials.gov processed this record on October 23, 2014