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Completed

NCT Number: NCT01223872

Childhood Cancer Survivors' Knowledge of Diagnosis,Treatment and Risk of Late Effects: Specialized Survivorship Clinic

This two-part research study will compare childhood cancer survivors receiving specialized follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up care.

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Key information

Conditions

Childhood Cancer Neoplasms

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment for primary malignancy per risk-adapted protocol
  • Age ≤ 21 years at time of diagnosis
  • Currently alive without evidence of disease
  • Off therapy for no more than 15 years

Exclusion criteria

-Patients who have received a bone marrow transplant

Treatment and study plan

interview

Other
  • Standard Interview (2-15 years from last treatment)
  • Demographic data interview (pre-initial study interview)

clinic visit and interview

Other
  • REACH Clinic Visit(initial or regular)
  • Post-REACH Clinic Interview (3mos from initial or regular clinic visit)
  • Demographic data interview(pre-initial study interview)

interviews and clinic visit

Other
  • Pre-REACH Clinic Interview(2-15 yrs from last treatment)
  • REACH Clinic Visit(initial or regular)
  • Post-REACH Clinic Interview(1mo from initial clinic visit)
  • Post-REACH Clinic Interview(3mos from initial or regular clinic visit)
  • Demographic data interview(pre-initial study interview)

Primary outcomes

  1. Knowledge gained by attending a multispecialty Survivorship Clinic which will be measured by comparison of self report with medical record data in both cross-sectional and longitudinal approach.

    Time frame: 12 months

    In addition to data from patient interviews, a review of medical records will include general patient demographic data as well as data regarding cancer diagnosis, treatment and ongoing follow-up care.

Secondary outcomes

  1. Characterizing how the initial consultation in a specialized clinic impacts childhood cancer survivors' knowledge of their cancer diagnosis, treatment, and risk of late effects by comparing patient's understanding among 3 sampled timepoints.

    Time frame: pre-clinic and a post-clinic interviews at 1 and 3 months.

  2. An analysis of differences in relative levels of recommended screening for late effects that childhood cancer survivors have received based on the type of their long-term follow-up care comparing medical records against Survivorship Care Plan.

    Time frame: 12 months

    Scored responses will allow for quantitative analysis of differences within and between the cohorts of patients

  3. A qualitative evaluation of program feedback will serve to improve the care provided in the REACH for Survivorship clinic

    Time frame: 12 months

    This data will be evaluated qualitatively for trends.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Childhood Cancer Survivors' Knowledge of Their Diagnosis, Treatment, and Risk of Late Effects: The Impact of Care in a Specialized Survivorship Clinic

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 19, 2010
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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