Clinical trial · Interventional
The "Hand-in-Hand Study": Improvement of Quality of Life in Palliative Cancer Patients Through Collaborative Advance Care Planning
Treatment as Usual vs. Additional Collaborative Advance Care Planning to Improve Quality of Life for Palliative Cancer Patients: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the effect of a collaborative advance care planning intervention on the quality of life in palliative oncological patients. Research indicates, that talking about wishes for end of life care and death, may improve the quality of life, but can be difficult for involved parties. The intervention especially developed for this study trys to reduce psychosocial barriers that make conversations about these topics difficult. The study will measure the effect of the intervention on patients and caregivers quality of life. The study will give additional information about implementation of advance care planning interventions in different care settings in a complex health care systems.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| End Stage Cancer | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham-Intervention | Behavioral | — | UNRESOLVED |
| Study-Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- 1.) Treatment as usual (TAU)
- description
- Patients assigned to this arm will receive palliative treatment as usual.
- type
- SHAM_COMPARATOR
- label
- 2.) Sham-Intervention
- description
- Patients assigned to this arm will receive an sham intervention with unspecific supportive therapy (i.e. listening, empathy etc., but no specific intervention rationale) and palliative treatment as usual.
- interventionNames
- Behavioral: Sham-Intervention
- type
- EXPERIMENTAL
- label
- 3.) Study-Intervention
- description
- Patients assigned to this arm will receive the study-intervention and palliative treatment as usual.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient \> 18 years * Patient with advance cancer in palliative setting * positive surprise question: the physician will not be surprised, if the patient died in the next 12 month * Patient is willing to take part in the study Exclusion Criteria: * Patients life expectancy below 3 month (estimated by physician) * Patients ECOG-status is \> 3 * Patient is not able to speak German * Patient is incapacitated to give informed consent
References
Publications (19)
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- BACKGROUNDCohen L, Parker PA, Vence L, Savary C, Kentor D, Pettaway C, Babaian R, Pisters L, Miles B, Wei Q, Wiltz L, Patel T, Radvanyi L. Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy. Psychosom Med. 2011 Apr;73(3):218-25. doi: 10.1097/PSY.0b013e31820a1c26. Epub 2011 Jan 21. PMID 21257977
- BACKGROUNDMarkowitz JC, Kocsis JH, Fishman B, Spielman LA, Jacobsberg LB, Frances AJ, Klerman GL, Perry SW. Treatment of depressive symptoms in human immunodeficiency virus-positive patients. Arch Gen Psychiatry. 1998 May;55(5):452-7. doi: 10.1001/archpsyc.55.5.452.