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| ID | Type | Description | Link |
|---|---|---|---|
| DKH-109967 | Other Grant/Funding Number | German Cancer Aid |
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| Name | Class |
|---|---|
| German Cancer Aid | OTHER |
| University of Hamburg-Eppendorf | OTHER |
| University Health Network, Toronto | OTHER |
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Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being.
Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The manualized psychotherapeutic intervention (CALM) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manualized CALM Intervention | Experimental |
| |
| Non-manualized supportive intervention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manualized CALM intervention | Behavioral | Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression module of the Patient Health Questionnaire (PHQ-9) | A reliable and valid 9-item measure of depression. | 6-months |
| Beck Depression-Inventory II (BDI-II) | A reliable and valid 21-item self-report instrument for evaluating the severity of depression. | 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anja Mehnert, Prof Dr | University Medical Center of Leipzig | Principal Investigator |
| Martin Härter, Prof Dr Dr | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig | Leipzig | Saxony | 04103 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30887126 | Derived | Scheffold K, Philipp R, Vehling S, Koranyi S, Engelmann D, Schulz-Kindermann F, Harter M, Mehnert-Theuerkauf A. Spiritual well-being mediates the association between attachment insecurity and psychological distress in advanced cancer patients. Support Care Cancer. 2019 Nov;27(11):4317-4325. doi: 10.1007/s00520-019-04744-x. Epub 2019 Mar 18. | |
| 26286128 |
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|
| Non-manualized supportive intervention. | Behavioral | Supportive psycho-oncological intervention. |
|
| Department of Medical Psychology, University Medical Center Hamburg-Eppendorf |
| Hamburg |
| 20246 |
| Germany |
| Scheffold K, Philipp R, Engelmann D, Schulz-Kindermann F, Rosenberger C, Oechsle K, Harter M, Wegscheider K, Lordick F, Lo C, Hales S, Rodin G, Mehnert A. Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial. BMC Cancer. 2015 Aug 19;15:592. doi: 10.1186/s12885-015-1589-y. |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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