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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
| Danish Cancer Society | OTHER |
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The purpose of this study is to identify whether patients with newly diagnosed advanced cancer benefit from a 12-week palliative rehabilitation program integrated with standard oncology treatment.
300 patients with newly diagnosed advanced cancer are planned to be enrolled. They wil be randomized at a 1:1 ratio to standard oncology treatment or standard oncology treatment plus a 12-week individually customized palliative rehabilitation program.
The intervention takes place in a specialized palliative setting and is planned after an individual consultation with the patient and his relatives. It can be adjusted during the 12 weeks according to the patient's symptoms and needs. All or part of the palliative rehabilitation program is organized as weekly group sessions at the hospital. The group sessions consist of lectures and debates followed by physical training. Professionals involved in the group sessions are doctors, nurses, physiotherapists, psychologists, occupational therapists, social workers, dietitians, and a priest.
If needed, the patient and/or his relatives can also be offered individual sessions.
All contacts with the patients or his relatives during the 12 weeks are registered in order to document the intervention retrospectively.
The intervention is evaluated using questionnaires. All participants receive a questionnaire at baseline and after 6 and 12 weeks. The questionnaire consists of EORTC-QLQ-C30 (a validated questionnaire developed to assess the quality of life of cancer patients) and HADS (the validated Hospital Anxiety and Depression Scale). At baseline the questionnaire is extended with the question: "Which of the following problems/ symptoms do you need help with the most?". The patients can choose between 12 defined problems matching 12 of the scales of EORTC-QLQ-C30 or "none of the above". The answer given by the patient is labeled "The Primary Problem".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | 150 patients will receive standard oncology treatment. | |
| Intervention arm | Active Comparator | 150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative rehabilitation | Behavioral | 12-week individually customized, specialized palliative rehabilitation program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the intervention on "The Primary Problem" chosen by the patient. | Comparing change from baseline to the weighed average of the 6 and 12-week follow-up of the scale in EORTC-QLQ-C30 that correlates to "The Primary Problem" of the patient (measured as area under the curve (AUC) of the change). If the patient has not chosen a "Primary Problem" the same measurement is done with the general health related quality of life scale. | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire | Comparing change from baseline to the weighed average of the 6 and 12 week follow-up of all the scales of EORTC-QLQ-C30 (measured as area under the curve (AUC) of the change). | 6 and 12 weeks |
| Effect of the intervention on worries and symptoms of anxiety and depression |
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Inclusion Criteria:
Participants must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Jensen, Assoc. prof. | Vejle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Vejle Hospital | Vejle | DK-7100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34000886 | Derived | Nottelmann L, Groenvold M, Vejlgaard TB, Petersen MA, Jensen LH. Early, integrated palliative rehabilitation improves quality of life of patients with newly diagnosed advanced cancer: The Pal-Rehab randomized controlled trial. Palliat Med. 2021 Jul;35(7):1344-1355. doi: 10.1177/02692163211015574. Epub 2021 May 17. | |
| 28835218 | Derived |
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Comparing HADS-scores in the two arms |
| 6 and 12 weeks |
| All cause mortality | Comparing mortality in the two arms using Kaplan-Meier survival curve. | 3 months after last data collection |
| Economic consequences | Comparing health related expenses in the two arms using register information about admissions to hospitals, visits with family doctors, emergency rooms etc. | 3 months after last data collection |
| Nottelmann L, Groenvold M, Vejlgaard TB, Petersen MA, Jensen LH. A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol. BMC Cancer. 2017 Aug 23;17(1):560. doi: 10.1186/s12885-017-3558-0. |