CancerNCT01395680
Trajectories of Regenerating Family Resilience in Adolescents With Cancer
An observational study of Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Family resilience is an important strength to help family to manage life challenge successfully, and to reorganize family function. However, few studies have showed the trajectory of family resilience in adolescents with cancer over time. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Cancer
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Oct 2012
- 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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: cancer adolescent aged 12-20 years old
Who may be able to join
- The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires.
Who cannot join
- terminal stage
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Dong-Tsamn Lin, MD, 886-2-23123456 ext. 65399, dtlin@ntuh.gov.tw
Chin-Mi Chen, RN, PhD
About this study
Family resilience is an important strength to help family to manage life challenge successfully, and to reorganize family function. However, few studies have showed the trajectory of family resilience in adolescents with cancer over time. The purposes of this study are to know the trend of family resilience in adolescents with cancer from previous 3 months to the first year of newly diagnosed, and to examine the relationships among family members' stress, family satisfaction, and family resilience in adolescents with cancer.
Read the detailed description
The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires. The study is designed as repeated measurement. Considering attrition rate may be more than 60%. Therefore, of necessity, the proposed sample size was set at 60 families.
Data will be collected by a structured questionnaire (a demographic questionnaire and 4 scales). The study consists of four times of data collection time point as follows: approximately 3 month (t1), 6 months (t2), 9 months (t3), and 12 months (t4) after the diagnosis of cancer in adolescents. Each participant may take 20-30 minutes to finish the structured questionnaire.
- Conditions
- Cancer
- Keywords
- cancer adolescent, resilience
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cancer adolescent | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
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 National Taiwan University HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dong-Tsamm Lin, MD, Principal investigator, National Taiwan University Hospital,Taipei,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395680
- Sponsor's protocol ID
- 201105004RC
- Status last verified
- Jun 2011
- First submitted
- 14 Jul 2011
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories of Regenerating Family Resilience in Adolescents With Cancer
- ClinicalTrials.gov ID
- NCT01395680
- Acronym / sponsor ID
- 201105004RC
- Conditions
- Cancer
- Keywords
- cancer adolescent, resilience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 15 Jul 2011 (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.
Family resilience is an important strength to help family to manage life challenge successfully, and to reorganize family function. However, few studies have showed the trajectory of family resilience in adolescents with cancer over time. The purposes of this study are to know the trend of family resilience in adolescents with cancer from previous 3 months to the first year of newly diagnosed, and to examine the relationships among family members' stress, family satisfaction, and family resilience in adolescents with cancer.
Detailed description
The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires. The study is designed as repeated measurement. Considering attrition rate may be more than 60%. Therefore, of necessity, the proposed sample size was set at 60 families.
Data will be collected by a structured questionnaire (a demographic questionnaire and 4 scales). The study consists of four times of data collection time point as follows: approximately 3 month (t1), 6 months (t2), 9 months (t3), and 12 months (t4) after the diagnosis of cancer in adolescents. Each participant may take 20-30 minutes to finish the structured questionnaire.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer adolescent | – | – |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- cancer adolescent aged 12-20 years old
Key inclusion criteria (1 listed)
- The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires.
Key exclusion criteria (1 listed)
- terminal stage
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2011.
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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.
Dong-Tsamm Lin, MD principal investigator
National Taiwan University Hospital,Taipei,Taiwan
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 National Taiwan University Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 15 Jul 2011. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Tsamm Lin, MD (886-2-23123456 ext. 65399, dtlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Jul 2011.