Early, Integrated, Specialized Palliative Rehabilitation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02332317|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2015
Last Update Posted : February 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Behavioral: Palliative rehabilitation||Not Applicable|
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".
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer.|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||July 2018|
No Intervention: Control arm
150 patients will receive standard oncology treatment.
Active Comparator: Intervention arm
150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program
Behavioral: Palliative rehabilitation
12-week individually customized, specialized palliative rehabilitation program
- Effect of the intervention on "The Primary Problem" chosen by the patient. [ Time Frame: 6 and 12 weeks ]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.
- Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire [ Time Frame: 6 and 12 weeks ]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).
- Effect of the intervention on worries and symptoms of anxiety and depression [ Time Frame: 6 and 12 weeks ]Comparing HADS-scores in the two arms
- All cause mortality [ Time Frame: 3 months after last data collection ]Comparing mortality in the two arms using Kaplan-Meier survival curve.
- Economic consequences [ Time Frame: 3 months after last data collection ]Comparing health related expenses in the two arms using register information about admissions to hospitals, visits with family doctors, emergency rooms etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332317
|Department of Oncology, Vejle Hospital|
|Vejle, Denmark, DK-7100|
|Study Chair:||Henrik Jensen, Assoc. prof.||Vejle Hospital|