NCT01742481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

December 3, 2012

Last Update Submit

May 10, 2016

Conditions

Keywords

childhood cancer survivorslong-term follow-up carehealth communicationethnic/racial minoritieslongterm survivors

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • requesting and obtaining medical records from pediatric oncology

    6 months

Study Arms (2)

Education and empowerment program

EXPERIMENTAL

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

self-guided empowerment and education

PLACEBO COMPARATOR

participants have information packet but receive no individualized support or assistance

Behavioral: Education and empowerment

Interventions

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

Education and empowerment programself-guided empowerment and education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 5, 2012

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

November 1, 2012

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations