Pituitary Tumor BenignNCT03927183
Extended Support for Persons With Pituitary Tumours After Surgery
A study testing person-centred practice in people with Pituitary Tumor Benign and Surgery, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Tumor Benign, Surgery
- What is being tested?
- person-centred practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSweden
- Study dates
- 6 Dec 2017to 28 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pituitary tumour; adenoma or craniopharyngioma
- Planned neurosurgery due to pituitary tumour
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medicine, Sahlgrenska University Hospital
Gothenburg, 413 46
About this study
Official title: Extended Support Within a Person-centred Practice After Surgery: a Quasi- Experimental Study for Persons With Pituitary Tumours
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
- Being tested
- person-centred practice
- Keywords
- Person-centred care, Clinical pathway, Intervention, Quasi-experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
person-centred practiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Person-centred practice | Other | Person-centred care Receives: Other: person-centred practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of inclusion until the date of one year follow up after surgery
Secondary outcomes (5)
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.
Measured: From date of inclusion until the date of one year follow up after surgery
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).
Measured: From date of inclusion until the date of one year follow up after surgery.
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.
Measured: 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
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).
Measured: 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
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).
Measured: From date of inclusion until the date of one year follow up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start6 Dec 2017
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary Tumor BenignStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi- experimental study with non-equivalent control group design, pretest-posttest study
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Jakobsson Ung, professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927183
- Sponsor's protocol ID
- GoPT
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2019
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Support Within a Person-centred Practice After Surgery: a Quasi- Experimental Study for Persons With Pituitary Tumours
- ClinicalTrials.gov ID
- NCT03927183
- Acronym / sponsor ID
- GoPT
- Conditions
- Pituitary Tumor Benign, Surgery
- Keywords
- Person-centred care, Clinical pathway, Intervention, Quasi-experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Apr 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi- experimental study with non-equivalent control group design, pretest-posttest study
| Arm | Type | Receives |
|---|---|---|
| Person-centred practice | Other | Other: person-centred practicePerson-centred care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pituitary tumour; adenoma or craniopharyngioma
- Planned neurosurgery due to pituitary tumour
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| person-centred practiceThe 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. | Other | Person-centred practice |
Primary outcome
Self- perceived psychological wellbeing
Time frame: From date of inclusion until the date of one year follow up after surgery
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).
5 secondary outcomes
Person-centred content in medical records
Time frame: From date of inclusion until the date of one year follow up after surgery
Self-reported health assessed with EQ-5D-5L
Time frame: From date of inclusion until the date of one year follow up after surgery.
Fatigue assessed with the Multidimensional Fatigue Inventory (MFI-20)
Time frame: 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
Time frame: 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
Time frame: From date of inclusion until the date of one year follow up after surgery
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Eva Jakobsson Ung, professor principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing person-centred practice in people with Pituitary Tumor Benign and Surgery, run by Göteborg University at 1 site in Sweden.
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 2 inclusion and 2 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Self- perceived psychological wellbeing (time frame: From date of inclusion until the date of one year follow up after surgery). 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 6 Apr 2025.