CancerNCT00788476
Childhood Cancer Survivor Survey
An observational study of Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: 1. To explore current lifestyle practices, health status, and quality of life among childhood cancer survivors and parent/guardians who are identified as "primary caregivers." 2. To explore childhood cancer survivors' and "primary caregivers'" awareness of future health risks. 3. Read more about this study
- Who is it for?
- Ages 8 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Survey
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2013
- Phase
- Observational
- 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 8 to 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Childhood cancer survivors between ages of 8 and 28 years of age and their primary caregivers.
Who may be able to join
- Inclusion criteria for childhood cancer survivors: 1) diagnosed between 1992-2007 with central nervous system tumors, sarcomas, leukemia, or lymphoma; 2) off active treatment for at least six-months, and alive with no evidence of progressive disease; 3) currently between age 8 (i.e., at an age at which they could be reasonably expected to complete a survey and where validated instruments exist) and 34 (cutpoint based on the possibility that individuals were almost 18 in 1992 and decade has since passed); and 4) able to speak or read English.
- Inclusion criteria for parents/guardians: 1) parents/guardians of childhood cancer survivors diagnosed from 1992-2007 with central nervous system tumors, sarcomas, leukemia, or lymphoma who completed active treatment at least six-months ago and who currently are alive with no evidence of disease; 2) parents/guardians of a survivor who is currently 2-34 years of age; 3) self-identified as the current "primary caregiver" of the survivor if the survivor is age 2-17 OR identified by the survivor as the "primary caregiver" if the survivor is age 18-34; and 4) able to speak or read English.
Who cannot join
- Exclusion criteria for childhood cancer survivors: 1) diagnosed with cancers other than central nervous system tumors, sarcomas, leukemia, or lymphoma; 2) diagnosed with cancer either prior to 1992 or after 2007; 3) currently on treatment; 4) currently diagnosed with progressive cancer; 5) deceased; 6) under age 8 or over age 34; or 7) non-English speaking or reading.
- Exclusion criteria for parent/guardians: 1) parent/guardians of childhood cancer survivors who were diagnosed with cancer before 1992 or after 2007 OR with cancers other than CNS tumors, sarcomas, leukemia, or lymphoma OR whose children are currently on treatment, have progressive cancer or are deceased OR whose children are currently <2 or >34 years old; 2) non-English speaking/reading; or 3) do not self-identify as being the current "primary caregiver" of childhood cancer survivors ages 2-17 or are not identified as being the primary caregiver of childhood cancer survivors who are age 18+.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Needs Assessment Survey in Childhood Cancer Survivors and Their Parents
Objectives:
- To explore current lifestyle practices, health status, and quality of life among childhood cancer survivors and parent/guardians who are identified as "primary caregivers."
- To explore childhood cancer survivors' and "primary caregivers'" awareness of future health risks.
- To explore interest in various lifestyle interventions and delivery channels among childhood cancer survivors and their "primary caregivers."
- To explore factors which may serve as mediators or moderators of future lifestyle interventions that target childhood cancer survivors and their "primary caregivers," e.g., strength of the caregiver-child bond, geographic distance from one another, and level of education.
Read the detailed description
A mailed survey will be conducted that will assess the health behaviors (diet, exercise, and tobacco-use) of childhood cancer survivors, and the behaviors of identified "primary caregivers" (see definition under inclusion criteria). In addition, these surveys will assess awareness of longterm health risks, quality of life (QOL), strength of the child-caregiver bond, body image, body weight status, functional status, barriers to lifestyle change, and interest in various lifestyle interventions and potential channels for delivery. Mailed surveys (with telephone follow-up) will be sent to MDACC childhood cancer survivors diagnosed from 1998 - 2007 who are survivors of central nervous system (CNS) tumors, sarcomas, lymphoma or leukemia.
- Conditions
- Cancer
- Being tested
- Survey
- Keywords
- Needs Assessment Survey, Childhood Cancer Survivors, Parents, Primary Caregiver, Survey
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Also called Questionnaire
Survey packets to adult (>18 years old) childhood cancer survivors who return to MDACC for follow-up appointments within the next 12-months and conduct a mailed survey with the remaining participants and their "primary caregivers" i.e. guardians of survivors who are currently under age 18.
| Study group | Role | What they receive |
|---|---|---|
| Childhood Cancer Survivors | Not described Receives: Other: Survey | |
| Primary Caregivers | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response Rate to Survey
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joann L. Ater, MD, BA, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788476
- Sponsor's protocol ID
- 2008-0490
- Status last verified
- Oct 2013
- First submitted
- 7 Nov 2008
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs Assessment Survey in Childhood Cancer Survivors and Their Parents
- ClinicalTrials.gov ID
- NCT00788476
- Acronym / sponsor ID
- 2008-0490
- Conditions
- Cancer
- Keywords
- Needs Assessment Survey, Childhood Cancer Survivors, Parents, Primary Caregiver, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Nov 2008 (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.
Objectives:
- To explore current lifestyle practices, health status, and quality of life among childhood cancer survivors and parent/guardians who are identified as "primary caregivers."
- To explore childhood cancer survivors' and "primary caregivers'" awareness of future health risks.
- To explore interest in various lifestyle interventions and delivery channels among childhood cancer survivors and their "primary caregivers."
- To explore factors which may serve as mediators or moderators of future lifestyle interventions that target childhood cancer survivors and their "primary caregivers," e.g., strength of the caregiver-child bond, geographic distance from one another, and level of education.
Detailed description
A mailed survey will be conducted that will assess the health behaviors (diet, exercise, and tobacco-use) of childhood cancer survivors, and the behaviors of identified "primary caregivers" (see definition under inclusion criteria). In addition, these surveys will assess awareness of longterm health risks, quality of life (QOL), strength of the child-caregiver bond, body image, body weight status, functional status, barriers to lifestyle change, and interest in various lifestyle interventions and potential channels for delivery. Mailed surveys (with telephone follow-up) will be sent to MDACC childhood cancer survivors diagnosed from 1998 - 2007 who are survivors of central nervous system (CNS) tumors, sarcomas, lymphoma or leukemia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Childhood Cancer Survivors | – | Other: Survey |
| Primary Caregivers | – | Other: Survey |
Who may qualify
- Ages
- 8 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Childhood cancer survivors between ages of 8 and 28 years of age and their primary caregivers.
Key inclusion criteria (2 listed)
- Inclusion criteria for childhood cancer survivors: 1) diagnosed between 1992-2007 with central nervous system tumors, sarcomas, leukemia, or lymphoma; 2) off active treatment for at least six-months, and alive with no evidence of progressive disease; 3) currently between age 8 (i.e., at an age at which they could be reasonably expected to complete a survey and where validated instruments exist) and 34 (cutpoint based on the possibility that individuals were almost 18 in 1992 and decade has since passed); and 4) able to speak or read English.
- Inclusion criteria for parents/guardians: 1) parents/guardians of childhood cancer survivors diagnosed from 1992-2007 with central nervous system tumors, sarcomas, leukemia, or lymphoma who completed active treatment at least six-months ago and who currently are alive with no evidence of disease; 2) parents/guardians of a survivor who is currently 2-34 years of age; 3) self-identified as the current "primary caregiver" of the survivor if the survivor is age 2-17 OR identified by the survivor as the "primary caregiver" if the survivor is age 18-34; and 4) able to speak or read English.
Key exclusion criteria (2 listed)
- Exclusion criteria for childhood cancer survivors: 1) diagnosed with cancers other than central nervous system tumors, sarcomas, leukemia, or lymphoma; 2) diagnosed with cancer either prior to 1992 or after 2007; 3) currently on treatment; 4) currently diagnosed with progressive cancer; 5) deceased; 6) under age 8 or over age 34; or 7) non-English speaking or reading.
- Exclusion criteria for parent/guardians: 1) parent/guardians of childhood cancer survivors who were diagnosed with cancer before 1992 or after 2007 OR with cancers other than CNS tumors, sarcomas, leukemia, or lymphoma OR whose children are currently on treatment, have progressive cancer or are deceased OR whose children are currently <2 or >34 years old; 2) non-English speaking/reading; or 3) do not self-identify as being the current "primary caregiver" of childhood cancer survivors ages 2-17 or are not identified as being the primary caregiver of childhood cancer survivors who are age 18+.
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 |
|---|---|---|
| SurveyAlso: QuestionnaireSurvey packets to adult (>18 years old) childhood cancer survivors who return to MDACC for follow-up appointments within the next 12-months and conduct a mailed survey with the remaining participants and their "primary caregivers" i.e. guardians of survivors who are currently under age 18. | Other | Childhood Cancer Survivors, Primary Caregivers |
Primary outcome
Patient Response Rate to Survey
Time frame: 2 Years
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 9 Jan 2015.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Joann L. Ater, MD, BA principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by M.D. Anderson Cancer Center 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 2 inclusion and 2 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 9 Jan 2015. 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. 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?
Patient Response Rate to Survey (time frame: 2 Years). 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 9 Jan 2015.