Early, Integrated, Specialized Palliative Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer.

Conditions
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Advanced Cancer

Intervention / Treatment
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* Behavioral: Palliative rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must: be diagnosed with non-resectable cancer less than 8 weeks before inclusion. For patients with prostate cancer they must be refered to systemic oncology treatment for the first time less than 8 weeks before inclusion. be fit to receive standard oncology treatment and accepting treatment read and understand Danish sign informed consent Exclusion Criteria: contact with a specialized palliative unit within the last year before inclusion unability to cooperate in the study missing informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>150 patients will receive standard oncology treatment. | |
| Active Comparator: Intervention arm<br>150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program | Behavioral: Palliative rehabilitation<br>* 12-week individually customized, specialized palliative rehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced cancer, Early integration, Palliative rehabilitation