NCT02332317

Early, Integrated, Specialized Palliative Rehabilitation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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".

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Palliative rehabilitation	12-week individually customized, specialized palliative rehabilitation program

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2015-01-06
• Last updated: 2021-06-01

Locations

1 site across 1 country: Denmark