Advanced CancerNCT02332317
Early, Integrated, Specialized Palliative Rehabilitation
A study testing Palliative rehabilitation in people with Advanced Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Palliative rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contact with a specialized palliative unit within the last year before inclusion
- unability to cooperate in the study
- missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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".
- Conditions
- Advanced Cancer
- Being tested
- Palliative rehabilitation
- Keywords
- Advanced cancer, Early integration, Palliative rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative rehabilitationBehavioural
12-week individually customized, specialized palliative rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | 150 patients will receive standard oncology treatment. |
| Intervention arm | Active comparator | 150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program Receives: Behavioral: Palliative rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the intervention on "The Primary Problem" chosen by the patient.
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.
Measured: 6 and 12 weeks
Secondary outcomes (4)
Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire
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).
Measured: 6 and 12 weeks
Effect of the intervention on worries and symptoms of anxiety and depression
Comparing HADS-scores in the two arms
Measured: 6 and 12 weeks
All cause mortality
Comparing mortality in the two arms using Kaplan-Meier survival curve.
Measured: 3 months after last data collection
Economic consequences
Comparing health related expenses in the two arms using register information about admissions to hospitals, visits with family doctors, emergency rooms etc.
Measured: 3 months after last data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Henrik Jensen, Assoc. prof., Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332317
- Sponsor's protocol ID
- Pal-Rehab
- Status last verified
- Sep 2018
- First submitted
- 30 Dec 2014
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34000886Nottelmann 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.
PubMed 28835218
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer.
- ClinicalTrials.gov ID
- NCT02332317
- Acronym / sponsor ID
- Pal-Rehab
- Conditions
- Advanced Cancer
- Keywords
- Advanced cancer, Early integration, Palliative rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Danish Cancer Society
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –150 patients will receive standard oncology treatment. |
| Intervention arm | Active comparator | Behavioral: Palliative rehabilitation150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- contact with a specialized palliative unit within the last year before inclusion
- unability to cooperate in the study
- missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative rehabilitation12-week individually customized, specialized palliative rehabilitation program | Behavioural | Intervention arm |
Primary outcome
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.
4 secondary outcomes
Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire
Time frame: 6 and 12 weeks
Effect of the intervention on worries and symptoms of anxiety and depression
Time frame: 6 and 12 weeks
All cause mortality
Time frame: 3 months after last data collection
Economic consequences
Time frame: 3 months after last data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 34000886Nottelmann 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.
- Derived from this study: PubMed 28835218Nottelmann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Jensen, Assoc. prof. study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative rehabilitation in people with Advanced Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the intervention on "The Primary Problem" chosen by the patient. (time frame: 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.