CancerNCT02205853
Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.
A study testing The patient-directed (PD) strategy and The multi-faceted (MF) strategy in people with Cancer and Fatigue, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- The patient-directed (PD) strategy and The multi-faceted (MF) strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Start not givento Oct 2017
- 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
- patients:
- preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases.
- Adults
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
- Healthcare professionals:
- involved in cancer care in one of the participating hospitals
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500HB
C. IJsbrandy, drs., charlotte.ijsbrandy@radboudumc.nl
About this study
Official title: An Evaluation of a Patient-directed Strategy Compared With a Multi-faceted Strategy to Implement Physical Cancer Rehabilitation Programmes; a Controlled Before and After Study.
The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.
Read the detailed description
The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.
We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.
A stepwise approach will be followed:
Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital).
Step 2: Selection and development of interventions to create a PD and MF strategy during expert's roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs.
Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital.
- Being tested
- The patient-directed (PD) strategy, The multi-faceted (MF) strategy
- Keywords
- Oncology Service Hospital, Patient-centred, Exercise, Neoplasms, Rehabilitation, Qualitative Research, Health Plan Implementation, Quality of Health Care, Guidelines, Quality of Life
- Medical subject headings
- Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patient-directed (PD) strategyOther
The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
The multi-faceted (MF) strategyOther
The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
| Study group | Role | What they receive |
|---|---|---|
| The patient-directed (PD) strategy | Other | A single-faceted patient-directed (PD) strategy that will embed the change at patient level. Receives: Other: The patient-directed (PD) strategy |
| The multi-faceted (MF) strategy | Other | A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels. Receives: Other: The multi-faceted (MF) strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
Measured: baseline and at follow-up
The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
Measured: baseline and at follow-up
Secondary outcomes (3)
Quality of life
A pre- and post measurement of 'QoL' will be done. The differences between the pre- and post measurement will be measured.
Measured: baseline and at follow-up
Patientempowerment
A pre- and post measurement of 'patientempowerment' will be done. The differences between the pre- and post measurement will be measured.
Measured: baseline and at follow-up
Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
A pre- and post measurement of ' the Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
Measured: baseline and at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosella Hermens, Radboud University Medical Center
- Investigators
- C. IJsbrandy, MD, Principal investigator, Radboud Univeristy Medical Centre NijmegenR.P.M.G. Hermens, PhD, Study chair, Radboud Univeristy Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205853
- Sponsor's protocol ID
- NKI 2010-4854
- Status last verified
- Aug 2015
- First submitted
- 21 Jul 2014
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
IJsbrandy C, Ottevanger PB, Groen WG, Gerritsen WR, van Harten WH, Hermens RP. Study protocol: an evaluation of the effectiveness, experiences and costs of a patient-directed strategy compared with a multi-faceted strategy to implement physical cancer rehabilitation programmes for cancer survivors in a European healthcare system; a controlled before and after study. Implement Sci. 2015 Sep 7;10:128. doi: 10.1186/s13012-015-0312-3.
PubMed 26345182
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Patient-directed Strategy Compared With a Multi-faceted Strategy to Implement Physical Cancer Rehabilitation Programmes; a Controlled Before and After Study.
- ClinicalTrials.gov ID
- NCT02205853
- Acronym / sponsor ID
- NKI 2010-4854
- Keywords
- Oncology Service Hospital, Patient-centred, Exercise, Neoplasms, Rehabilitation, Qualitative Research, Health Plan Implementation, Quality of Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Primary completion
- Oct 2017 (estimated)
- First posted
- 31 Jul 2014 (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 aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.
Detailed description
The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.
We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.
A stepwise approach will be followed:
Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital).
Step 2: Selection and development of interventions to create a PD and MF strategy during expert's roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs.
Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The patient-directed (PD) strategy | Other | Other: The patient-directed (PD) strategyA single-faceted patient-directed (PD) strategy that will embed the change at patient level. |
| The multi-faceted (MF) strategy | Other | Other: The multi-faceted (MF) strategyA multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases.
- Adults
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
- involved in cancer care in one of the participating hospitals
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The patient-directed (PD) strategyThe patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients. | Other | The patient-directed (PD) strategy |
| The multi-faceted (MF) strategyThe multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects. | Other | The multi-faceted (MF) strategy |
Primary outcome
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Time frame: baseline and at follow-up
A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
Time frame: baseline and at follow-up
A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
3 secondary outcomes
Quality of life
Time frame: baseline and at follow-up
Patientempowerment
Time frame: baseline and at follow-up
Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
Time frame: baseline and at follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Derived from this study: PubMed 26345182IJsbrandy C, Ottevanger PB, Groen WG, Gerritsen WR, van Harten WH, Hermens RP. Study protocol: an evaluation of the effectiveness, experiences and costs of a patient-directed strategy compared with a multi-faceted strategy to implement physical cancer rehabilitation programmes for cancer survivors in a European healthcare system; a controlled before and after study. Implement Sci. 2015 Sep 7;10:128. doi: 10.1186/s13012-015-0312-3.
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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.
C. IJsbrandy, MD principal investigator
Radboud Univeristy Medical Centre Nijmegen
R.P.M.G. Hermens, PhD study chair
Radboud Univeristy Medical Centre Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The patient-directed (PD) strategy and The multi-faceted (MF) strategy in people with Cancer and Fatigue, run by Radboud University Medical Center at 1 site in Netherlands.
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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 7 Sep 2015. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact C. IJsbrandy, MD (+31 (0)24 3615305, charlotte.ijsbrandy@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'. (time frame: baseline and at follow-up). The study lists 2 primary outcomes in all. 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 NCT02205853, which also lists 1 linked publication.
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 7 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.