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Extended Support for Persons With Pituitary Tumours After Surgery

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ClinicalTrials.gov Identifier: NCT03927183
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Göteborg University

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.

Condition or disease Intervention/treatment Phase
Pituitary Tumor Benign Surgery Other: person-centred practice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A quasi- experimental study with non-equivalent control group design, pretest-posttest study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Extended Support Within a Person-centred Practice After Surgery: a Quasi- Experimental Study for Persons With Pituitary Tumours
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Person-centred practice
Person-centred care
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Person-centred content in medical records [ Time Frame: From date of inclusion until the date of one year follow up after surgery ]
    Degree of person-centredness in medical records according to dimensions in a protocol to review content in medical records.

  2. Self-reported health assessed with EQ-5D-5L [ Time Frame: From date of inclusion until the date of one year follow up after surgery. ]
    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).

  3. 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. ]
    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.

  4. 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 ]
    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).

  5. 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 ]
    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).


Other Outcome Measures:
  1. Clinical observations of pulse rate [ Time Frame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization ]
    Frequency of documented pulse rate during hospitalization. The medical records are reviewed retrospectively.

  2. Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge: rating [ Time Frame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization ]
    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.

  3. Quality of care assessed as documented information in medical records on planned medical care at discharge: rating [ Time Frame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization ]
    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.

  4. Clinical observations of weight [ Time Frame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization ]
    Frequency of documented clinical observations of weight (kg) during hospitalization. The medical records are reviewed retrospectively.

  5. Clinical observations of respiratory rate [ Time Frame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization ]
    Frequency of documented clinical observations of respiratory rate during hospitalization. The medical records are reviewed retrospectively.

  6. Clinical observations of body temperature [ Time Frame: From date of admission to inpatient care after surgery until the date of discharge, up to 60 days of hospitalization ]
    Frequency of documented clinical observations of body temperature (degrees celsius) during hospitalization. The medical records are reviewed retrospectively.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927183


Contacts
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Contact: Eva Jakobsson Ung, professor +46734028521 eva.jakobsson@fhs.gu.se

Locations
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Sweden
Department of Medicine, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 46
Contact: Eva Jakobsson Ung, professor         
Sub-Investigator: Gudmundur Johannsson, Professor         
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Eva Jakobsson Ung, professor Göteborg University

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03927183     History of Changes
Other Study ID Numbers: GoPT
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Person-centred care
Clinical pathway
Intervention
Quasi-experimental
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms