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

University of Illinois

Status: Completed

Conditions: Childhood Cancer

Treatments: Behavioral: Education and empowerment

Study type: Interventional

Funder types: Other

Identifiers

NCT01742481

K23CA124451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Education and empowerment program

Experimental group

Description:

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

Treatment:

Behavioral: Education and empowerment

self-guided empowerment and education

Placebo Comparator group

Description:

participants have information packet but receive no individualized support or assistance

Treatment:

Behavioral: Education and empowerment