We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02332317
Previous Study | Return to List | Next Study

Early, Integrated, Specialized Palliative Rehabilitation

This study is currently recruiting participants.
Verified November 2017 by Vejle Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02332317
First Posted: January 6, 2015
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Bispebjerg Hospital
Danish Cancer Society
Information provided by (Responsible Party):
Vejle Hospital
  Purpose
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.

Condition Intervention
Advanced Cancer Behavioral: Palliative rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer.

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • 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

  • All cause mortality [ Time Frame: 3 months after last data collection ]
    Comparing mortality in the two arms using Kaplan-Meier survival curve.

  • 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.


Estimated Enrollment: 300
Actual Study Start Date: December 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332317


Contacts
Contact: Henrik Jensen, Assoc. prof. lars.henrik.jensen@rsyd.dk
Contact: Lise Nottelmann, MD lise.nottelmann@rsyd.dk

Locations
Denmark
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Henrik Jensen, Assoc. prof.       lars.henrik.jensen@rsyd.dk   
Contact: Lise Nottelmann, MD       lise.nottelmann@rsyd.dk   
Principal Investigator: Lise Nottelmann, MD         
Sponsors and Collaborators
Vejle Hospital
Bispebjerg Hospital
Danish Cancer Society
Investigators
Study Chair: Henrik Jensen, Assoc. prof. Vejle Hospital
  More Information

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT02332317     History of Changes
Other Study ID Numbers: Pal-Rehab
First Submitted: December 30, 2014
First Posted: January 6, 2015
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Vejle Hospital:
Advanced cancer
Early integration
Palliative rehabilitation