Early, Integrated, Specialized Palliative Rehabilitation

May 28, 2021 updated by: Vejle Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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".

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, DK-7100
        • Department of Oncology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 and 12 weeks
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
6 and 12 weeks
All cause mortality
Time Frame: 3 months after last data collection
Comparing mortality in the two arms using Kaplan-Meier survival curve.
3 months after last data collection
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.
3 months after last data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Collaborators

Bispebjerg Hospital
Danish Cancer Society

Investigators

  • Study Chair: Henrik Jensen, Assoc. prof., Vejle Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 30, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pal-Rehab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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