Childhood CancerSPEACNCT01742481
Study to Education Childhood Cancer Survivors About Survivorship Care
A study testing Education and empowerment in people with Childhood Cancer, run by University of Illinois Chicago at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Education and empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ever seen for risk-based follow-up care as an adult (18 or older)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
Official title: Childhood Cancer Survivor Program to Empower Action in Care
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.
Read the 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.
- Conditions
- Childhood Cancer
- Being tested
- Education and empowerment
- Keywords
- childhood cancer survivors, long-term follow-up care, health communication, ethnic/racial minorities, longterm survivors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and empowermentBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Education and empowerment |
| self-guided empowerment and education | Placebo comparator | participants have information packet but receive no individualized support or assistance Receives: Behavioral: Education and empowerment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lisa Sharp, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742481
- Sponsor's protocol ID
- K23CA124451
- Acronym
- SPEAC
- Status last verified
- May 2016
- First submitted
- 3 Dec 2012
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Cancer Survivor Program to Empower Action in Care
- ClinicalTrials.gov ID
- NCT01742481
- Acronym / sponsor ID
- SPEAC / K23CA124451
- Conditions
- Childhood Cancer
- Keywords
- childhood cancer survivors, long-term follow-up care, health communication, ethnic/racial minorities, longterm survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and empowerment program | Experimental | Behavioral: Education and empowermentThree 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 |
| self-guided empowerment and education | Placebo comparator | Behavioral: Education and empowermentparticipants have information packet but receive no individualized support or assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Ever seen for risk-based follow-up care as an adult (18 or older)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and empowermentThree 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 | Behavioural | Education and empowerment program, self-guided empowerment and education |
Primary outcome
scheduling a survivorship visit
Time frame: 6 months
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.
1 secondary outcome
requesting and obtaining medical records from pediatric oncology
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and empowerment in people with Childhood Cancer, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scheduling a survivorship visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.