Clinical trial NCT03927183: Extended Support for Persons With Pituitary Tumours After Surgery
Official title: Extended Support Within a Person-centred Practice After Surgery: a Quasi- Experimental Study for Persons With Pituitary Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Tumor Benign
Surgery
Keywords: Person-centred care
Clinical pathway
Intervention
Quasi-experimental
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A quasi- experimental study with non-equivalent control group design, pretest-posttest study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with pituitary tumours often live with life-long consequences of their disease. Treatment options include surgery, radiotherapy and medical therapy. Symptoms associated with the tumour and/or its treatment affects several areas of life. The year after pituitary surgery constitutes an important time-period with medical evaluations of surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time-point is limited. Care based on person-centredness has exclusively been promoted which comprises a care where care providers inquire how patients view their health situation and what their needs, resources, and preferences are. Person-centredness focuses on preserving patient autonomy, function, and well-being and strives to emphasize patient involvement through equalizing power between health care professionals and the patient with the main goal of an enhanced health situation. The aim of the study is to evaluate if a support within a person-centered care practice one year after surgery increases wellbeing for patients with pituitary tumours.


Eligibility criteria: Inclusion Criteria:

1. Pituitary tumour; adenoma or craniopharyngioma
2. Planned neurosurgery due to pituitary tumour

Exclusion Criteria:

1. Pituitary carcinomas
2. Health conditions which may restrain the understanding of the study and/or the ability to adhere to the protocol for example decreased cognitive functions or drug addiction.

Primary outcomes:
measure: Self- perceived psychological wellbeing
timeFrame: From date of inclusion until the date of one year follow up after surgery
Secondary outcomes:
measure: Person-centred content in medical records
timeFrame: From date of inclusion until the date of one year follow up after surgery
measure: Self-reported health assessed with EQ-5D-5L
timeFrame: From date of inclusion until the date of one year follow up after surgery.
measure: Fatigue assessed with the Multidimensional Fatigue Inventory (MFI-20)
timeFrame: From date of inclusion until the date of one year follow up after surgery.
measure: Quality of care assessed with the Quality from the Patient Perspective questionnaire
timeFrame: From date of inclusion until the date of one year follow up after surgery
measure: Level of general self-efficacy assessed with the General Self-Efficacy scale
timeFrame: From date of inclusion until the date of one year follow up after surgery
Other outcomes:
measure: Clinical observations of pulse rate
timeFrame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
measure: Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge: rating
timeFrame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
measure: Quality of care assessed as documented information in medical records on planned medical care at discharge: rating
timeFrame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
measure: Clinical observations of weight
timeFrame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
measure: Clinical observations of respiratory rate
timeFrame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
measure: Clinical observations of body temperature
timeFrame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
Locations:
city: Gothenburg
country: Sweden
facility: Department of Medicine, Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Eva Jakobsson Ung, professor
role: PRINCIPAL_INVESTIGATOR
References: