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Completed

NCT Number: NCT02332317

Early, Integrated, Specialized Palliative Rehabilitation

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative rehabilitation

Behavioral

12-week individually customized, specialized palliative rehabilitation program

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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

  3. All cause mortality

    Time frame: 3 months after last data collection

    Comparing mortality in the two arms using Kaplan-Meier survival curve.

  4. 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.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Bispebjerg Hospital
  • Danish Cancer Society

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jan 6, 2015
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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