Pediatric CancerNCT00456209
Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact on Occupations
An observational study of Pediatric Cancer, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
The purpose of this phenomenological study is to discover and illuminate the experiences of adolescents in the treatment process of cancer and the meanings they attach to these experiences, while maintaining their daily routines. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Pediatric Cancer
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2011
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents being treating for cancer and the impact of their lived experience on engagement in occupations and social participation.
Who may be able to join
- Pediatric cancer patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact of Occupations
The purpose of this phenomenological study is to discover and illuminate the experiences of adolescents in the treatment process of cancer and the meanings they attach to these experiences, while maintaining their daily routines. The focus area of interest lies in the impact side-effects (psychological and physical) which these treatments may have on an individual's ability to participate with peers, maintain social activities, and be involved in daily occupation(s).
Read the detailed description
This study will explore the following research questions: 1. How do adolescent patients in the treatment process of cancer perceive and describe their experience of engaging in occupational routines? 2. What effect does the treatment process of cancer have on an adolescent's ability to participate in life situations such as creating and maintaining relationships with family, friends, peers, students, or people with similar backgrounds?
By doing this study, researchers hope to gain information so that occupational therapists can increase the profession's present body of knowledge and better understand these individuals at a transitional period in their lives.
- Conditions
- Pediatric Cancer
- Keywords
- Lived Experiences, Adolescents, Cancer Treatment, Occupations
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle changes
Participants will be interviewed for observations of disease effect.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2008
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Grimaldi, MA, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456209
- Sponsor's protocol ID
- 06.02.112
- Status last verified
- Feb 2014
- First submitted
- 3 Apr 2007
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact of Occupations
- ClinicalTrials.gov ID
- NCT00456209
- Acronym / sponsor ID
- 06.02.112
- Conditions
- Pediatric Cancer
- Keywords
- Lived Experiences, Adolescents, Cancer Treatment, Occupations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Apr 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.
The purpose of this phenomenological study is to discover and illuminate the experiences of adolescents in the treatment process of cancer and the meanings they attach to these experiences, while maintaining their daily routines. The focus area of interest lies in the impact side-effects (psychological and physical) which these treatments may have on an individual's ability to participate with peers, maintain social activities, and be involved in daily occupation(s).
Detailed description
This study will explore the following research questions: 1. How do adolescent patients in the treatment process of cancer perceive and describe their experience of engaging in occupational routines? 2. What effect does the treatment process of cancer have on an adolescent's ability to participate in life situations such as creating and maintaining relationships with family, friends, peers, students, or people with similar backgrounds?
By doing this study, researchers hope to gain information so that occupational therapists can increase the profession's present body of knowledge and better understand these individuals at a transitional period in their lives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents being treating for cancer and the impact of their lived experience on engagement in occupations and social participation.
Key inclusion criteria (1 listed)
- Pediatric cancer patients
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lifestyle changes
Time frame: 1 month
Participants will be interviewed for observations of disease effect.
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 4 Feb 2014.
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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.
Gary Grimaldi, MA principal investigator
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 Pediatric Cancer, run by Hackensack Meridian Health 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 1 inclusion and 0 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 4 Feb 2014. 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?
Lifestyle changes (time frame: 1 month). 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 4 Feb 2014.