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Early, Integrated, Specialized Palliative Rehabilitation

V

Vejle Hospital

Status

Completed

Conditions

Advanced Cancer

Treatments

Behavioral: Palliative rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT02332317
Pal-Rehab

Details and patient eligibility

About

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.

Full 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".

Enrollment

301 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

301 participants in 2 patient groups

Control arm
No Intervention group
Description:
150 patients will receive standard oncology treatment.
Intervention arm
Active Comparator group
Description:
150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program
Treatment:
Behavioral: Palliative rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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