Pancreatic CancerNCT02900677
Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
A study testing Physical and nutrition program in people with Pancreatic Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aims of this three-year study are to: 1. explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months. 2. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Physical and nutrition program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2015to Jul 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with pancreatic cancer and are going to receive surgery.
Who cannot join
- poor functional status
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei
Shiow-Ching Shun, PHD, 886-2-2312-3456 ext. 88439, scshun@ntu.edu.tw
Shun
About this study
Official title: Developing and Testing the Effects of Patient-centered Prehabilitation Program on Improving Fatigue, Nutritional Status, and Quality of Life in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
The aims of this three-year study are to:
- explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months.
- develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.
Read the detailed description
Develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.
- Conditions
- Pancreatic Cancer
- Being tested
- Physical and nutrition program
- Keywords
- Pancreatic Cancer, Fatigue, Nutrition, Quality of Life
- Medical subject headings
- Pancreatic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical and nutrition programBehavioural
6 education programs with physical enhancement and nutrition related information for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Physical and nutrition program | Experimental | 6 education programs with physical enhancement and nutrition related information for 12 weeks. Receives: Behavioral: Physical and nutrition program |
| Control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report Questionnaire
The questionnaire includes 25 items to assess the physical symptom distresses
Measured: Change from baseline physical symptom at 12 months
Secondary outcomes (1)
Self-report Questionnaire
The questionnaire includes 14 items to assess fatigue intensity and duration
Measured: Change from baseline fatigue at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Shiow-Ching Shun, PHD, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900677
- Sponsor's protocol ID
- 201505160RINB
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yang HY, Shun SC, Lee YH, Liou YT, Chou YJ, Kuo HJ, Tien YW, Lai SR, Hung H. Trajectories of perioperative nutritional status in patients with pancreatic tumor after surgery in six months. Eur J Oncol Nurs. 2024 Oct;72:102687. doi: 10.1016/j.ejon.2024.102687. Epub 2024 Aug 21.
PubMed 39288676
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing the Effects of Patient-centered Prehabilitation Program on Improving Fatigue, Nutritional Status, and Quality of Life in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
- ClinicalTrials.gov ID
- NCT02900677
- Acronym / sponsor ID
- 201505160RINB
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Fatigue, Nutrition, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 14 Sep 2016 (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 aims of this three-year study are to:
- explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months.
- develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.
Detailed description
Develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical and nutrition program | Experimental | Behavioral: Physical and nutrition program6 education programs with physical enhancement and nutrition related information for 12 weeks. |
| Control | No intervention | –usual care |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with pancreatic cancer and are going to receive surgery.
Key exclusion criteria (1 listed)
- poor functional status
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 |
|---|---|---|
| Physical and nutrition program6 education programs with physical enhancement and nutrition related information for 12 weeks | Behavioural | Physical and nutrition program |
Primary outcome
Self-report Questionnaire
Time frame: Change from baseline physical symptom at 12 months
The questionnaire includes 25 items to assess the physical symptom distresses
1 secondary outcome
Self-report Questionnaire
Time frame: Change from baseline fatigue at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Derived from this study: PubMed 39288676Yang HY, Shun SC, Lee YH, Liou YT, Chou YJ, Kuo HJ, Tien YW, Lai SR, Hung H. Trajectories of perioperative nutritional status in patients with pancreatic tumor after surgery in six months. Eur J Oncol Nurs. 2024 Oct;72:102687. doi: 10.1016/j.ejon.2024.102687. Epub 2024 Aug 21.
- Individual participant dataSharing planned: Undecided
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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.
Shiow-Ching Shun, PHD study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical and nutrition program in people with Pancreatic 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 14 Sep 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 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 Shiow-Ching Shun, PHD (886-2-23123456 ext. 88439, scshun@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report Questionnaire (time frame: Change from baseline physical symptom at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02900677, which also lists 1 linked publication.
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 14 Sep 2016.