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HELP II - Heidelberg decicion aids for lung Cancer patients and their implementation

HELP II - Heidelberg decicion aids for lung Cancer patients and their implementation - HELP II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028023
Enrollment
178
Registered
2022-02-08
Start date
2022-04-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TREATMENT DECISIONS IN METASTATIC LUNG CANCER

Interventions

Group 1: Intervention group: use of decision aid with decision coaching Group 2: Control Group: usual care, no decsion aid, no decision coaching

Sponsors

Bristol Myers Squibb-Stiftung Immunonkologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: at least 18 years old; capable of giving consent; good knowledge of German; Diagnosis of incurable stage IV lung cancer and stadium IIIb and IIIc; willingness to participate in the study.

Exclusion criteria

Exclusion criteria: Knowledge of German is not sufficient; is in a state of health that does not allow conversation due to a vital threat; has limitations in cognitive function, minor, incapacitated.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the sum score of the Clarity of Personal Attitude dimension of the Decisional Conflict Scale (DCS). In addition to the descriptive evaluation of the target variable, its analysis is carried out by means of group comparisons (nonparametric comparison: van elteren test) between the two study groups in which the stratification of randomization is taken into account. Missing values in the primary outcome are replaced by multiple imputation.

Secondary

MeasureTime frame
Decision Self-Efficacy Scale Patient Involvement in Care Scale (PICS) Preparation for Decision-Making Scale (PDMS-D) EQ5D-5L HADS-D Focus groups with healthcare professionals For the sum scores and scales of the secondary target variables, group comparisons (with consideration of stratification) are also carried out in order to be able to determine significant differences. Depending on the group, the Cochran-Mantel-Haenszel test, the van Elteren test, or a covariance analysis are used.

Countries

Germany

Contacts

Public ContactLaura Unsöld

Thoraxklinik Heidelberg

Laura.Unsoeld@med.uni-heidelberg.de06221 396 8266

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026