An interventional study of Shared decision-making program and Usual Care in Cancer, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-04.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Health services research
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This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.
10,824 studies on the registry are indexed under Neoplasms; 2,325 are open to participants now.
This study's enrollment of 2,131 is above the median of 60 across 7,706 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
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Exclusion Criteria for participating patients:
Inclusion Criteria for participating health care professionals:
Exclusion Criteria for participating health care professionals:
Other: Shared decision-making program
Other: Usual Care
The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components: 1. shared decision-making trainings for health care professionals, 2. individual coaching for physicians, 3. patient activation strategy, 4. provision of patient information material and decision aids, 5. revision of the clinics quality management documents, and 6. critical reflection of current organization of multidisciplinary team meetings. Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3.
No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.
Change in uptake of shared decision-making from the patients' perspective
Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9)
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Change in uptake of shared decision-making from external observers' perspective
Action to employ shared decision-making as measured by the German version of the Observer OPTION 5 scale using audio-recorded medical encounters. The Observer OPTION 5 scale measures the extent to which clinicians involve patients in decision-making. Each of the 5 items is assessed on a scale ranging from 0 to 4 with higher values indicating more involvement of patients in decision-making. A sum score is calculated (ranging from 0 to 20) and rescaled to be between 0 to 100, for ease of interpretation.
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Acceptability of shared decision-making from the health care providers' perspective
Perception that shared decision-making is agreeable, palatable, or satisfactory as measured by an adapted version of the acceptability survey developed by McColl et al.
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Readiness for implementing change from the health care professionals' perspective
As measured by an adapted version of the Organizational Readiness for Implementing Change (ORIC) measure
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Appropriateness of shared decision-making from the health care professionals' perspective
Perceived fit, relevance, or compatibility of shared decision-making for the given practice setting as measured by an adapted version of the IcanSDM measure
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Change in penetration of shared decision-making at the clinic level
Integration of shared decision-making within a setting and its subsystems as measured by routine data from patient experience surveys of the clinics
Time frame: baseline, 3 years
Change in penetration of shared decision-making in multidisciplinary team meetings
Integration of shared decision-making within a setting and its subsystems as measured by an adapted version of the Metric for the Observation of Decision Making in Multidisciplinary Team Meetings (MDT-MODe)
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Plan to share: Undecided
Ran from Mar 2018 to primary completion in Sep 2020, 30 months.
Of 1,985 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 30 months is close to that.
Counting every sponsor, half of 2,060 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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