Extended Support for Persons With Pituitary Tumours After Surgery

Surgery Clinical Trial

Official title:

Extended Support Within a Person-centred Practice After Surgery: a Quasi- Experimental Study for Persons With Pituitary Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03927183
• Other study ID #: GoPT
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2019
• Source: Göteborg University
• Contact: Eva Jakobsson Ung, professor
• Phone: +46734028521
• Email: eva.jakobsson[@]fhs.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor Benign
• Surgery

Intervention

Other:
• person-centred practice
The structure and content of the intervention is constructed on principles for person-centredness. Each patients in the intervention are allocated a hospital-initiated nurse care manager during one year after surgery. Self-management support is primarily conducted between the patient and the nurse care manager. The primary goal of the support is to facilitate patients own resources in managing illness and health education on e.g. physical activity and diet. The support also comprises patient-held documentation and health plan. Other components of the intervention comprise accessibility and continuity which is secured by a structured clinical care pathway with planned care and defined care contacts. The patient has continuous access to the nurse care manager by telephone and face-to-face contact according to a structured follow-up plan. An interdisciplinary team as well as a patient education program constitutes distinct parts of the support during the year after surgery.

Locations

Country	Name	City	State
Sweden	Department of Medicine, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical observations of pulse rate	Frequency of documented pulse rate during hospitalization. The medical records are reviewed retrospectively.	From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
Other	Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge: rating	All information in the medical records during hospitalization are reviewed retrospectively. Rating is made regarding the presence (yes or no) of information on current medication at a daily basis and at discharge.	From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
Other	Quality of care assessed as documented information in medical records on planned medical care at discharge: rating	All information in the medical records during hospitalization are reviewed retrospectively. Rating is made regarding the presence (yes or no) of information on planned medical care at discharge.	From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
Other	Clinical observations of weight	Frequency of documented clinical observations of weight (kg) during hospitalization. The medical records are reviewed retrospectively.	From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
Other	Clinical observations of respiratory rate	Frequency of documented clinical observations of respiratory rate during hospitalization. The medical records are reviewed retrospectively.	From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
Other	Clinical observations of body temperature	Frequency of documented clinical observations of body temperature (degrees celsius) during hospitalization. The medical records are reviewed retrospectively.	From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization
Primary	Self- perceived psychological wellbeing	The outcome is assessed with The Psychological General Well-being scale (PGWB), a questionnaire with 22 items, comprising six subscales: anxiety, depression, positive well-being, self-control, general health and vitality. The Swedish version of the questionnaire is valid. Total score of 132 is an overall score of the values from each item (score 1-6 for each item). Higher value is indicative for better psychological well-being. A sum score for each subscale can be calculated, minimum and maximum score; anxiety (5-30), depression (3-18), positive well-being (4-24), self-control (3-18), general health (3-18) and vitality (4-24).	From date of inclusion until the date of one year follow up after surgery
Secondary	Person-centred content in medical records	Degree of person-centredness in medical records according to dimensions in a protocol to review content in medical records.	From date of inclusion until the date of one year follow up after surgery
Secondary	Self-reported health assessed with EQ-5D-5L	Self-reported health is measured with the EuroQual-5Dimensions-5Levels questionnaire (EQ- 5D- 5L). The questionnaire comprises 1 item per dimension. The dimensions of importance for health which are included are; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients rate each item on a scale ranging from 1 (no problems) to 5 (extreme problems/unable to). A unique health state is defined by combining 1 level from each of the 5 dimensions. The questionnaire also includes EQ-VAS, in which the patients grade their current health status on an analogue scale from 0 (worst health) to 100 (best health).	From date of inclusion until the date of one year follow up after surgery.
Secondary	Fatigue assessed with the Multidimensional Fatigue Inventory (MFI-20)	Within MFI-20 general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue comprises five dimensions of fatigue. Fatigue in the preceding seven days is rated on a 5-point Likert scale from "yes, that is accurate to "no, that is not accurate". Subscale scores range from 4-20, where a high score represents greater fatigue.	From date of inclusion until the date of one year follow up after surgery.
Secondary	Quality of care assessed with the Quality from the Patient Perspective questionnaire	The outcome is assessed with the questionnaire Quality from the Patient Perspective. The questionnaire comprises four dimension Identity-oriented approach (13 items) and the sociocultural atmosphere (5 items), medical- technical competence (4 items) and physical-technical condition (3 items). Two kinds of assessments are being made at each item: whether things were being done (perceived reality) and whether the right things were being done (subjective significance). Items are rated on a four-point response scale ranging from 1 (do not agree at all) to 4 (completely agree). Each item also has a response option of "not applicable". Subscales can be reported item by item or combined in a subscale score (average of all responses within the subscale).	From date of inclusion until the date of one year follow up after surgery
Secondary	Level of general self-efficacy assessed with the General Self-Efficacy scale	General self-efficacy measures confidence in one's ability to handle difficult challenges in life. It includes 10 items, which are rated on a four- point Likert scale giving a summary score of 40 for the total scale (10-40).	From date of inclusion until the date of one year follow up after surgery