ClinicalTrials.Veeva

Menu

Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel vs a General Surgical Ward

D

Danderyd Hospital

Status

Completed

Conditions

Breast Cancer

Treatments

Other: IN2005E

Study type

Interventional

Funder types

Other

Identifiers

NCT02403973
2010/38-31/4

Details and patient eligibility

About

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.

Full 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.

Enrollment

151 patients

Sex

Female

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

151 participants in 2 patient groups

Patient hotel group
Other group
Treatment:
Other: IN2005E
Ward group
Other group
Treatment:
Other: IN2005E

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems