Early, Integrated, Specialized Palliative Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Balance, Activity and Quality of Life

NCT04772690

Advanced Cancer

COMPLETED NA

Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

NCT05984797

Cancer

RECRUITING NA

The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.

NCT01021371

HRQOL (Health Related Quality Of Life)

COMPLETED EARLY_PHASE1

Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course

NCT01086683

Neoplasms Breast Neoplasms Colorectal Neoplasms +1 more

COMPLETED PHASE2/PHASE3

Involvement of Patients and Relatives in the Course of Cancer Disease

NCT01060761

Rehabilitation Cancer Relatives

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control arm

150 patients will receive standard oncology treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention arm

150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program

Group Type ACTIVE_COMPARATOR

Palliative rehabilitation

Intervention Type BEHAVIORAL

12-week individually customized, specialized palliative rehabilitation program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Palliative rehabilitation

12-week individually customized, specialized palliative rehabilitation program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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