Extended Support for Persons With Pituitary Tumours After Surgery

NCT03927183 | Completed

• 1 other identifier: GoPT
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor Benign; Surgery

Keywords

Person-centred care; Clinical pathway; Intervention; Quasi-experimental

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Person-centred content in medical records

  From date of inclusion until the date of one year follow up after surgery

• Self-reported health assessed with EQ-5D-5L

  From date of inclusion until the date of one year follow up after surgery.

• Fatigue assessed with the Multidimensional Fatigue Inventory (MFI-20)

  From date of inclusion until the date of one year follow up after surgery.

• Quality of care assessed with the Quality from the Patient Perspective questionnaire

  From date of inclusion until the date of one year follow up after surgery

• Level of general self-efficacy assessed with the General Self-Efficacy scale

  From date of inclusion until the date of one year follow up after surgery

Other Outcomes (6)

• Clinical observations of pulse rate

  From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization

• Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge: rating

  From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization

• Quality of care assessed as documented information in medical records on planned medical care at discharge: rating

  From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization

Study Arms (1)

Person-centred practice

OTHER

Person-centred care

Other: person-centred practice

Interventions

person-centred practice OTHER

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.

Person-centred practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pituitary tumour; adenoma or craniopharyngioma
• Planned neurosurgery due to pituitary tumour

You may not qualify if:

• Pituitary carcinomas
• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Department of Medicine, Sahlgrenska University Hospital

Gothenburg, 413 46, Sweden

Location

Study Officials

• Eva Jakobsson Ung, professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A quasi- experimental study with non-equivalent control group design, pretest-posttest study

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: December 6, 2017
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)