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Treatment Decision-making in Patients With Recurrent High-grade Glioma
| Condition or disease |
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| Malignant Glioma Life Experiences |
High-Grade Glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. The life expectancy is short, and a majority of patients experience recurrence of tumour growth. At time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care.
In this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs.
Little is known about how the patients and their close relatives experience the recurrence and the decision-making process.
The objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence.
Data will be generated through semi-structured interviews. Interviews will be analysed and interpreted using a Ricoeur inspired method of qualitative analysis.
The study is part of a larger PhD-study.
| Study Type : | Observational |
| Estimated Enrollment : | 25 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process. |
| Actual Study Start Date : | May 6, 2019 |
| Estimated Primary Completion Date : | July 2020 |
| Estimated Study Completion Date : | March 2022 |
| Group/Cohort |
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Patients
Patients with recurrent high-grade glioma
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Relatives
Close relatives of patients with recurrent high-grade glioma
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- Experiences of patients and relatives [ Time Frame: Interviews are performed 2-6 weeks after the decision-making ]How patients and their close relatives experience the decision-making process
- Involvement preferences [ Time Frame: Interviews are performed 2-6 weeks after the decision-making ]The preferences of patients and relatives for being involved in the decision-making.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Two study populations:
- - Adult patients with recurrence of high-grade glioma who are offered surgical treatment as one of the treatment possibilities.
- - The adult relative most involved in the decision-making. The relative is apointed by the patient and the patient gives written concent to the relative' participation.
Inclusion Criteria:
- The patient is offered surgical treatment (after an assesment done by the multidisciplinary team)
- Able to speak and understand danish
- Able to participate in an interview
- Able to give informed concent for participation
Exclusion Criteria:
- Patients with severe cognitive impairment which prohibits them from either giving informed concent or participating in interview.
- Relatives are excluded if the patient do not give concent for the participation of relatives
| Contact: Helle von Essen, PhD-student | +45 2388 1722 | helle.sorensen.von.essen@rsyd.dk | |
| Contact: Karin Piil, Ass. profes. | +45 3545 0733 | Karin.Piil@regionh.dk |
| Denmark | |
| Copenhagen University Hospital; Rigshospitalet | Not yet recruiting |
| Copenhagen, Denmark | |
| Contact: Helle von Essen, PhD-student +45 23881722 helle.sorensen.von.essen@rsyd.dk | |
| Odense University Hospital | Recruiting |
| Odense, Denmark | |
| Contact: Helle von Essen, PhD-student +4523881722 helle.sorensen.von.essen@rsyd.dk | |
| Study Director: | Frantz Rom Poulsen, Professor | Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 8, 2019 | ||||||||
| First Posted Date | July 10, 2019 | ||||||||
| Last Update Posted Date | July 12, 2019 | ||||||||
| Actual Study Start Date | May 6, 2019 | ||||||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Treatment Decision-making in Patients With Recurrent High-grade Glioma | ||||||||
| Official Title | Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process. | ||||||||
| Brief Summary | This qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. With focus on the decision-making about treatment and care.. | ||||||||
| Detailed Description |
High-Grade Glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. The life expectancy is short, and a majority of patients experience recurrence of tumour growth. At time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care. In this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs. Little is known about how the patients and their close relatives experience the recurrence and the decision-making process. The objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence. Data will be generated through semi-structured interviews. Interviews will be analysed and interpreted using a Ricoeur inspired method of qualitative analysis. The study is part of a larger PhD-study. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population |
Two study populations:
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| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
25 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | March 2022 | ||||||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Denmark | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04013828 | ||||||||
| Other Study ID Numbers | OP870 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Helle Sørensen von Essen, Odense University Hospital | ||||||||
| Study Sponsor | Odense University Hospital | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Odense University Hospital | ||||||||
| Verification Date | July 2019 | ||||||||
