Clinical trial NCT02332317: Early, Integrated, Specialized Palliative Rehabilitation
Official title: A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: Advanced cancer
Early integration
Palliative rehabilitation
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: Danish Cancer Society
First posted: 2015-01-06
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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".

Eligibility criteria: 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

Primary outcomes:
measure: Effect of the intervention on "The Primary Problem" chosen by the patient.
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire
timeFrame: 6 and 12 weeks
measure: Effect of the intervention on worries and symptoms of anxiety and depression
timeFrame: 6 and 12 weeks
measure: All cause mortality
timeFrame: 3 months after last data collection
measure: Economic consequences
timeFrame: 3 months after last data collection
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Henrik Jensen, Assoc. prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.