Breast CancerNCT02403973
Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel vs a General Surgical Ward
A study testing IN2005E in people with Breast Cancer, run by Danderyd Hospital.
Trial summary
To explore the possible benefit of a patient hotel, a study was undertaken to test the hypothesis that perioperative care at a patient hotel would be valued better than care in a general ward. The study focuses solely on the patients' perspective and satisfaction of the care provided. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IN2005E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Nov 2014
- 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with a breast tumour, who were to undergo surgical treatment in order to remove a known cancer or to exclude cancerous changes in a diagnosed tumour
Who cannot join
- Insulin dependent diabetes
- Severe impairment of mobility
- A known coagulopathy
- Cancer surgery with a coherent primary reconstruction
- Severe cardiac illness
- An inability to understand Swedish
- Mental incapacity.
About this study
Official title: Randomized Clinical Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel Versus a General Surgical Ward
To explore the possible benefit of a patient hotel, a study was undertaken to test the hypothesis that perioperative care at a patient hotel would be valued better than care in a general ward. The study focuses solely on the patients' perspective and satisfaction of the care provided.
Read the detailed description
The study was designed as a prospective randomised controlled trial, carried out at a single centre (Danderyds University Hospital). The protocol was approved by the Ethical committee for human studies.
With a primary outcome that perioperative care at the hotel would be valued 15-20% higher than care in a general ward, a power analysis, two-sided with α = 0.05, indicated that a sample size of 150 was needed to attain a power of 80%.
The patients were randomised to receive pre- and postoperative care either in a general surgical ward or at a patient hotel by using a sealed envelope method.
To evaluate the patients' experiences of the care provided at the ward and the hotel, respectively, the Swedish validated version of the adult inpatient survey of 2005 (IN2005-E) was used.
Adjacent to the discharge from the ward or hotel, the patient was provided with the IN2005-E questionnaire, which was filled out before the patient left the facility. The filled out form was sealed in an envelope by the patient herself and thereafter sent to a separate institute (Indikator) for further analysis. Indikator is responsible for the majority of the statistical analysis of patient surveys in Sweden.
Patient characteristics were compared using a confidence interval of 95%. The SF-36 was analyzed with a two-sample t-test. The IN2005E was analyzed by a cross-tabulation of the data using the χ² test in SPSS 17.0. The significance level was set to < 0.05.
- Conditions
- Breast Cancer
- Being tested
- IN2005E
- Keywords
- Patient hotel, Patient Satisfaction, Perioperative care, IN2005E
- Medical subject headings
- Breast Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN2005EOther
IN2005E is a validated questionnaire that measures patient satisfaction
| Study group | Role | What they receive |
|---|---|---|
| Patient hotel group | Other | Not described Receives: Other: IN2005E |
| Ward group | Other | Not described Receives: Other: IN2005E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction regarding provided care associated with surgery for breast cancer
The IN2005-E is a quantitative questionnaire, based upon the Picker Adult Inpatient Questionnaire and is commonly used to examine specific aspects of patient satisfaction. The IN2005-E is comprised by questions that focus on whether a specific event occurred or not, rather than letting the patients rate their care in terms of how satisfied they are. By this design the influence of outside factors is reduced. The conceptual basis and design of the original questionnaire has been described in detail elsewhere (Cleary PD, Edgman-Levitan S, Roberts M, Moloney TW, McMullen W, Walker JD, Delbanco TL. "Patients evaluate their hospital care: a national survey". Health Affairs 1991; 10; 254-267. Cleary PD, Edgman-Levitan S, Walker JD, Gerteis M, Delbanco TL. "Using patient reports to improve the medical care: a preliminary report from 10 hospitals". Quality Management in Health Care 1993; 2: 31-8. http://nhssurveys.org/surveys/712)
Measured: in average 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startApr 2010
- Primary completionNov 2012
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Indikator - Institutet för kvalitetsindikatorer
- Responsible party
- Principal investigator, Madleen Huzell, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403973
- Sponsor's protocol ID
- 2010/38-31/4
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel Versus a General Surgical Ward
- ClinicalTrials.gov ID
- NCT02403973
- Acronym / sponsor ID
- 2010/38-31/4
- Conditions
- Breast Cancer
- Keywords
- Patient hotel, Patient Satisfaction, Perioperative care, IN2005E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Indikator - Institutet för kvalitetsindikatorer
- Study start
- Apr 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 31 Mar 2015 (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.
To explore the possible benefit of a patient hotel, a study was undertaken to test the hypothesis that perioperative care at a patient hotel would be valued better than care in a general ward. The study focuses solely on the patients' perspective and satisfaction of the care provided.
Detailed description
The study was designed as a prospective randomised controlled trial, carried out at a single centre (Danderyds University Hospital). The protocol was approved by the Ethical committee for human studies.
With a primary outcome that perioperative care at the hotel would be valued 15-20% higher than care in a general ward, a power analysis, two-sided with α = 0.05, indicated that a sample size of 150 was needed to attain a power of 80%.
The patients were randomised to receive pre- and postoperative care either in a general surgical ward or at a patient hotel by using a sealed envelope method.
To evaluate the patients' experiences of the care provided at the ward and the hotel, respectively, the Swedish validated version of the adult inpatient survey of 2005 (IN2005-E) was used.
Adjacent to the discharge from the ward or hotel, the patient was provided with the IN2005-E questionnaire, which was filled out before the patient left the facility. The filled out form was sealed in an envelope by the patient herself and thereafter sent to a separate institute (Indikator) for further analysis. Indikator is responsible for the majority of the statistical analysis of patient surveys in Sweden.
Patient characteristics were compared using a confidence interval of 95%. The SF-36 was analyzed with a two-sample t-test. The IN2005E was analyzed by a cross-tabulation of the data using the χ² test in SPSS 17.0. The significance level was set to < 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient hotel group | Other | Other: IN2005E |
| Ward group | Other | Other: IN2005E |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women with a breast tumour, who were to undergo surgical treatment in order to remove a known cancer or to exclude cancerous changes in a diagnosed tumour
Key exclusion criteria (7 listed)
- Insulin dependent diabetes
- Severe impairment of mobility
- A known coagulopathy
- Cancer surgery with a coherent primary reconstruction
- Severe cardiac illness
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 |
|---|---|---|
| IN2005EIN2005E is a validated questionnaire that measures patient satisfaction | Other | Patient hotel group, Ward group |
Primary outcome
Patient satisfaction regarding provided care associated with surgery for breast cancer
Time frame: in average 1 day
The IN2005-E is a quantitative questionnaire, based upon the Picker Adult Inpatient Questionnaire and is commonly used to examine specific aspects of patient satisfaction. The IN2005-E is comprised by questions that focus on whether a specific event occurred or not, rather than letting the patients rate their care in terms of how satisfied they are. By this design the influence of outside factors is reduced. The conceptual basis and design of the original questionnaire has been described in detail elsewhere (Cleary PD, Edgman-Levitan S, Roberts M, Moloney TW, McMullen W, Walker JD, Delbanco TL. "Patients evaluate their hospital care: a national survey". Health Affairs 1991; 10; 254-267. Cleary PD, Edgman-Levitan S, Walker JD, Gerteis M, Delbanco TL. "Using patient reports to improve the medical care: a preliminary report from 10 hospitals". Quality Management in Health Care 1993; 2: 31-8. http://nhssurveys.org/surveys/712)
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 31 Mar 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing IN2005E in people with Breast Cancer, run by Danderyd Hospital.
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 7 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient satisfaction regarding provided care associated with surgery for breast cancer (time frame: in average 1 day). 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 31 Mar 2015.