CancerParticipNCT04061902
Participation in Surgical Cancer Care
An observational study of Cancer, run by Linkoeping University at 1 site in Sweden.
Trial summary
Patients that are involved in their health care is associated with improved treatment outcomes, rehabilitation and recovery. In this research project we aim to assess patient participation among patients who had surgery for liver, bile duct (cholangiocarcinoma) and pancreatic cancer and follow a fast-track recovery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Participation with enhanced patient perioperative information
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2016to 1 Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had surgery for liver, bile duct and pancreatic cancer and follow a fast-track recovery program.
Who may be able to join
- patients who had surgery for liver, bile duct and pancreatic cancer and follow a fast-track recovery program >18 years old
Who cannot join
- cognitive dysfunction
- could not master the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Participation in Surgical Cancer Care; Patient, Next of Kin and Health Care Professionals' Perspective
Patients that are involved in their health care is associated with improved treatment outcomes, rehabilitation and recovery. In this research project we aim to assess patient participation among patients who had surgery for liver, bile duct (cholangiocarcinoma) and pancreatic cancer and follow a fast-track recovery program.
Read the detailed description
Implementation of Fast-track surgery programs for patients with tumors in the upper GI-tract are steadily increasing because of the decreased costs, shorter hospital stays and a decrease in morbidity, mortality and post-operative complications associated with Fast-track programs. The health care team follows a standardized care program consisting of a check list with day-to-day evidence based procedures which reduces postoperative complications. Postoperative recovery is described as a process in which patients strive for a return to a normalized daily life.
Major surgeries are associated with pain, nausea, postoperative ileus , fatigue, post-operative complications such as wound infections , heart or lung dysfunctions and thromboembolic complications. In the last 20 years perioperative care, anesthesia and surgery for patients suffering from tumors has developed greatly. This has led to development and evaluation of concepts to enhance the patients recovery after different types of surgery. Fast-track surgery concepts results in decreased morbidity and enhanced recovery by implemented evidence based principles in analgesia, anesthesia, fluid management, nutrition, ambulation, minimal invasive surgery and reduction of surgical stress.
In recent years there's been a shift in focus of patient care. Patients are moving from a passive role to being more participant in their care. In Sweden, patients have the legal right to participate in their own care, and health care should be individualized for each patient's needs and abilities. Being involved in your own health care contributes to increased motivation and an improvement of the situation. This may in some cases lead to better treatment outcomes and greater satisfaction with the given care. A severe symptom burden can make the patient a passive recipient of health care without initiative or strength to be involved in the care. In patients with malignancies of the upper gastrointestinal tract monitoring and symptom relief of importance to stimulate opportunities for participation.
Aim
To investigate and describe patient participation among patients who had surgery for liver, bile duct (cholangiocarcinoma) and pancreatic cancer and follow a fast-track recovery program.
Specific aims
- To identify and describe patient participation in patients who follow a fast track-care concept
- To explore patients experiences of patient participation
- To identify, describe and evaluate patient assessed health related quality of life; and relations with patient participation
- Conditions
- Cancer
- Being tested
- Participation with enhanced patient perioperative information
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation with enhanced patient perioperative informationOther
Improved information and dialogue about the care goals in the fast track protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment planning
Higher clinical significant score in the subscale Treatment planning in a questionnarie to measure patient participation (Arnetz et al). All scale items ask the patient to rate a specific statement on a 4-point Likert scale ranging from 1 (no, not at all) to 4 (yes, to a great degree). For all scales, higher scores indicate more positive ratings.
Measured: Two weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Dec 2016
- Primary completion19 Feb 2020
- Study completion1 Aug 2020
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 CancerStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jenny Drott, Ostergotland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061902
- Sponsor's protocol ID
- Part.19
- Acronym
- Particip
- Status last verified
- Sep 2020
- First submitted
- 16 Aug 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amin A, Norden M, Fomichov V, Bjornsson B, Lindhoff Larsson A, Sandstrom P, Drott J. Patient-reported participation in hepatopancreatobiliary surgery cancer care: A pilot intervention study with patient-owned fast-track protocols. Eur J Cancer Care (Engl). 2022 May;31(3):e13570. doi: 10.1111/ecc.13570. Epub 2022 Mar 10.
PubMed 35274386
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation in Surgical Cancer Care; Patient, Next of Kin and Health Care Professionals' Perspective
- ClinicalTrials.gov ID
- NCT04061902
- Acronym / sponsor ID
- Particip / Part.19
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 20 Aug 2019 (actual)
- 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.
Patients that are involved in their health care is associated with improved treatment outcomes, rehabilitation and recovery. In this research project we aim to assess patient participation among patients who had surgery for liver, bile duct (cholangiocarcinoma) and pancreatic cancer and follow a fast-track recovery program.
Detailed description
Implementation of Fast-track surgery programs for patients with tumors in the upper GI-tract are steadily increasing because of the decreased costs, shorter hospital stays and a decrease in morbidity, mortality and post-operative complications associated with Fast-track programs. The health care team follows a standardized care program consisting of a check list with day-to-day evidence based procedures which reduces postoperative complications. Postoperative recovery is described as a process in which patients strive for a return to a normalized daily life.
Major surgeries are associated with pain, nausea, postoperative ileus , fatigue, post-operative complications such as wound infections , heart or lung dysfunctions and thromboembolic complications. In the last 20 years perioperative care, anesthesia and surgery for patients suffering from tumors has developed greatly. This has led to development and evaluation of concepts to enhance the patients recovery after different types of surgery. Fast-track surgery concepts results in decreased morbidity and enhanced recovery by implemented evidence based principles in analgesia, anesthesia, fluid management, nutrition, ambulation, minimal invasive surgery and reduction of surgical stress.
In recent years there's been a shift in focus of patient care. Patients are moving from a passive role to being more participant in their care. In Sweden, patients have the legal right to participate in their own care, and health care should be individualized for each patient's needs and abilities. Being involved in your own health care contributes to increased motivation and an improvement of the situation. This may in some cases lead to better treatment outcomes and greater satisfaction with the given care. A severe symptom burden can make the patient a passive recipient of health care without initiative or strength to be involved in the care. In patients with malignancies of the upper gastrointestinal tract monitoring and symptom relief of importance to stimulate opportunities for participation.
Aim
To investigate and describe patient participation among patients who had surgery for liver, bile duct (cholangiocarcinoma) and pancreatic cancer and follow a fast-track recovery program.
Specific aims
- To identify and describe patient participation in patients who follow a fast track-care concept
- To explore patients experiences of patient participation
- To identify, describe and evaluate patient assessed health related quality of life; and relations with patient participation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had surgery for liver, bile duct and pancreatic cancer and follow a fast-track recovery program.
Key inclusion criteria (1 listed)
- patients who had surgery for liver, bile duct and pancreatic cancer and follow a fast-track recovery program >18 years old
Key exclusion criteria (2 listed)
- cognitive dysfunction
- could not master the Swedish language
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 |
|---|---|---|
| Participation with enhanced patient perioperative informationImproved information and dialogue about the care goals in the fast track protocol. | Other | – |
Primary outcome
Treatment planning
Time frame: Two weeks post discharge
Higher clinical significant score in the subscale Treatment planning in a questionnarie to measure patient participation (Arnetz et al). All scale items ask the patient to rate a specific statement on a 4-point Likert scale ranging from 1 (no, not at all) to 4 (yes, to a great degree). For all scales, higher scores indicate more positive ratings.
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 3 Sep 2020.
- Derived from this study: PubMed 35274386Amin A, Norden M, Fomichov V, Bjornsson B, Lindhoff Larsson A, Sandstrom P, Drott J. Patient-reported participation in hepatopancreatobiliary surgery cancer care: A pilot intervention study with patient-owned fast-track protocols. Eur J Cancer Care (Engl). 2022 May;31(3):e13570. doi: 10.1111/ecc.13570. Epub 2022 Mar 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Linkoeping University at 1 site in Sweden.
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 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 3 Sep 2020. 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 Sweden. 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?
Treatment planning (time frame: Two weeks post discharge). 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 NCT04061902, 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 3 Sep 2020.