Peritoneal NeoplasmsNCT00502177
Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
An observational study of Peritoneal Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2009-0528, "A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults with Desmoplastic Small… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Neoplasms
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2007to 29 Aug 2018
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
Who may be able to join
- All participants must be English or Spanish speaking.
- A patient enrolled on Protocol 2009-0528, and/or one parent or adult non-parent primary caretaker of the child enrolled on Protocol 2009-0528.
- Patients greater than or equal to 1 year.
Who cannot join
- Patients not enrolled on Protocol 2009-0528 will be excluded from this study.
- Patients less than 1 year.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Objectives:
The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2009-0528, "A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults with Desmoplastic Small Round Cell Tumor (DSRCT) and Other Non-carcinomas".
Read more
Specific Aim 1: To examine the quality of life of patients who undergo HIPEC longitudinally. It is hypothesized that physical health and functioning concerns, as reported by parent/child dyads on the Pediatric Quality of Life Cancer Module Version 3.0 (PedsQL) and the PedsQL 4.0 Generic Core Scales, will will remain stable or improve, following the surgical procedures and peritoneal perfusion described in Protocol 2009-0528.
Specific Aim 2: To assess parent and patient perception of the relative benefit of HIPEC longitudinally. It is hypothesized that parents and patients will perceive HIPEC to be beneficial across time, despite the temporary postoperative pain and discomfort that is associated with the procedure. This will be done by means of a non-validated question that is specific to the surgery.
Exploratory Aim: To determine whether quality of life following HIPEC varies by demographic factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment modalities. Some patients who undergo HIPEC might subsequently be treated with other Phase II chemotherapy agents and/or palliative radiation, and comparing quality of life in these subgroups will be of value. Also the quality of life for groups of patients enrolled in Protocol 2009-0528 at each intraoperative cisplatin dose level will be compared.
Read the detailed description
Child Participant:
Study Participation:
If you agree to take part in this study, you will complete questionnaires about your quality of life. If you do not want to participate in this study, your parent or caregiver may still participate and complete the parent/caregiver questionnaires if he/she chooses.
The questionnaires will ask about your experiences with pain, nausea, anxiety, worry, thinking and reasoning ability, physical appearance, communication, and your emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total, or longer if you need more time. You will also be asked about whether you worry about the surgery being effective.
If you are 4 years old or younger, your parent/caregiver will fill out the questionnaires for you.
If you are between 5 and 7 years old, the interviewer will go over the questionnaires with you.
If you are between 8 and 18 years old, you will fill out the questionnaires on your own.
The questionnaires will be filled out in the week before the surgery, 1 month after the surgery, 3 months and 6 months after the surgery.
You will only come in if you already have a scheduled visit because of the study you are presently on. However, if you are no longer on that study then you will still be asked to complete the questionnaires at the 1, 3 and 6-month time points. This can be done by telephone or at other regularly scheduled visits at those time points.
Length of Study:
Your participation in this study will be over after you finish the 6-month questionnaires.
This is an investigational study. Up to 20 parents and 20 children will participate in this study. All will be enrolled at M. D. Anderson.
Parent/Caregiver Participant:
Parent Participation:
If you agree to take part in this study, you will complete questionnaires about your perception of your child's quality of life. If your child does not want to participate in this study, you may still participate and complete the parent/caregiver questionnaire, if you so choose. If your child is too ill to participate in this study, you will not be asked to complete his/her questionnaires on his/her behalf.
The questionnaires will ask about your child's quality of life regarding pain, nausea, anxiety, worry, cognitive functioning (thinking and reasoning), physical appearance, communication, and his or her emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total.
You will also be asked a surgery-specific question about whether your child worries about the effectiveness of the surgery.
Length of Study:
Your participation in this study will be over after completion of the 6-month questionnaires.
This is an investigational study. Up to 20 parents and 20 children will participate in this study. All will be enrolled at MD Anderson.
- Conditions
- Peritoneal Neoplasms
- Being tested
- Questionnaire
- Keywords
- Continuous Hyperthermic Peritoneal Perfusion, Peritoneal Neoplasms, Quality of Life, Questionnaire, Survey, CHPP
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
QOL Questionnaires taking a total of 10 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Quality of Life Questionnaire | Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL 4.0 Generic Core Scale
The mean change in PedsQL 4.0 Generic Core Total Score over time (i.e., prior to operation vs. 6-months post-operation. The PedsQL 4.0 Generic Core will be administered to each child to ascertain their quality of life at the two time points).
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 posted17 Jul 2007 (estimated)
- Study start19 Jun 2007
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal NeoplasmsStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Hayes-Jordan, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502177
- Sponsor's protocol ID
- 2006-1106
- Status last verified
- Oct 2018
- First submitted
- 16 Jul 2007
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
- ClinicalTrials.gov ID
- NCT00502177
- Acronym / sponsor ID
- 2006-1106
- Conditions
- Peritoneal Neoplasms
- Keywords
- Continuous Hyperthermic Peritoneal Perfusion, Peritoneal Neoplasms, Quality of Life, Questionnaire, Survey, CHPP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Jun 2007 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 17 Jul 2007 (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:
The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2009-0528, "A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults with Desmoplastic Small Round Cell Tumor (DSRCT) and Other Non-carcinomas".
Specific Aim 1: To examine the quality of life of patients who undergo HIPEC longitudinally. It is hypothesized that physical health and functioning concerns, as reported by parent/child dyads on the Pediatric Quality of Life Cancer Module Version 3.0 (PedsQL) and the PedsQL 4.0 Generic Core Scales, will will remain stable or improve, following the surgical procedures and peritoneal perfusion described in Protocol 2009-0528.
Specific Aim 2: To assess parent and patient perception of the relative benefit of HIPEC longitudinally. It is hypothesized that parents and patients will perceive HIPEC to be beneficial across time, despite the temporary postoperative pain and discomfort that is associated with the procedure. This will be done by means of a non-validated question that is specific to the surgery.
Exploratory Aim: To determine whether quality of life following HIPEC varies by demographic factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment modalities. Some patients who undergo HIPEC might subsequently be treated with other Phase II chemotherapy agents and/or palliative radiation, and comparing quality of life in these subgroups will be of value. Also the quality of life for groups of patients enrolled in Protocol 2009-0528 at each intraoperative cisplatin dose level will be compared.
Detailed description
Child Participant:
Study Participation:
If you agree to take part in this study, you will complete questionnaires about your quality of life. If you do not want to participate in this study, your parent or caregiver may still participate and complete the parent/caregiver questionnaires if he/she chooses.
The questionnaires will ask about your experiences with pain, nausea, anxiety, worry, thinking and reasoning ability, physical appearance, communication, and your emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total, or longer if you need more time. You will also be asked about whether you worry about the surgery being effective.
If you are 4 years old or younger, your parent/caregiver will fill out the questionnaires for you.
If you are between 5 and 7 years old, the interviewer will go over the questionnaires with you.
If you are between 8 and 18 years old, you will fill out the questionnaires on your own.
The questionnaires will be filled out in the week before the surgery, 1 month after the surgery, 3 months and 6 months after the surgery.
You will only come in if you already have a scheduled visit because of the study you are presently on. However, if you are no longer on that study then you will still be asked to complete the questionnaires at the 1, 3 and 6-month time points. This can be done by telephone or at other regularly scheduled visits at those time points.
Length of Study:
Your participation in this study will be over after you finish the 6-month questionnaires.
This is an investigational study. Up to 20 parents and 20 children will participate in this study. All will be enrolled at M. D. Anderson.
Parent/Caregiver Participant:
Parent Participation:
If you agree to take part in this study, you will complete questionnaires about your perception of your child's quality of life. If your child does not want to participate in this study, you may still participate and complete the parent/caregiver questionnaire, if you so choose. If your child is too ill to participate in this study, you will not be asked to complete his/her questionnaires on his/her behalf.
The questionnaires will ask about your child's quality of life regarding pain, nausea, anxiety, worry, cognitive functioning (thinking and reasoning), physical appearance, communication, and his or her emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total.
You will also be asked a surgery-specific question about whether your child worries about the effectiveness of the surgery.
Length of Study:
Your participation in this study will be over after completion of the 6-month questionnaires.
This is an investigational study. Up to 20 parents and 20 children will participate in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Life Questionnaire | – | Behavioral: QuestionnairePatients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
Key inclusion criteria (3 listed)
- All participants must be English or Spanish speaking.
- A patient enrolled on Protocol 2009-0528, and/or one parent or adult non-parent primary caretaker of the child enrolled on Protocol 2009-0528.
- Patients greater than or equal to 1 year.
Key exclusion criteria (2 listed)
- Patients not enrolled on Protocol 2009-0528 will be excluded from this study.
- Patients less than 1 year.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQOL Questionnaires taking a total of 10 minutes to complete. | Behavioural | Quality of Life Questionnaire |
Primary outcome
PedsQL 4.0 Generic Core Scale
Time frame: 6 Months
The mean change in PedsQL 4.0 Generic Core Total Score over time (i.e., prior to operation vs. 6-months post-operation. The PedsQL 4.0 Generic Core will be administered to each child to ascertain their quality of life at the two time points).
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 24 Oct 2018.
- University of Texas 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.
Andrea Hayes-Jordan, MD principal investigator
M.D. 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 Peritoneal Neoplasms, 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 3 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 24 Oct 2018. 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?
PedsQL 4.0 Generic Core Scale (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 24 Oct 2018.