PainNCT02333968
Self-management Support in Cancer Pain
A study testing Self-management support in people with Pain, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Self-management support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2014to Aug 2015
- 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
- Diagnosis of cancer
- Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
- Cancer (treatment related) pain > 2 weeks
- Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)
- Living at home
Who cannot join
- Expected life expectancy < 3 months
- Chronic non-cancer pain
- Known cognitive impairments
- Participation in other studies that interfere with this study
- Not being able to read and understand the Dutch language
- Reduced vision
- Non-reachable by phone
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Atrium Medical Center
Heerlen
Asiong Jie, MD, PhD, +31 455766666, G.Jie@atriummc.nl
- Recruiting
Maastricht University Medical Center
Maastricht
Annemie Courtens, PhD, +31 433877548, a.courtens@mumc.nl
About this study
Official title: Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed. Important components include monitoring, feedback, education, and nurse support. Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use. Besides, a cost-evaluation and summative process evaluation will be performed.
- Conditions
- Pain
- Being tested
- Self-management support
- Keywords
- Cancer pain, Self-management, Randomized controlled trial
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management supportBehavioural
The 12-week intervention consists of an iPad application for patients that is connected to a web application for nurses. Every morning and evening patients register pain and related symptoms by use of a pain diary. Patients are also requested to register medication intake. Graphical feedback is provided based on registered pain scores and medication intakes. Patients receive education on causes and treatment of pain, symptoms that require action, and methods to better control pain. Patients communicate with nurses via text message functionality within the application. Specialized nurses remotely monitor and analyze the patients' situation once every workday. Nurses have the opportunity to collaborate with the treating physician, pain specialist or multidisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Self-management support Receives: Behavioral: Self-management support |
| Control group | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
As measured with the Brief Pain Inventory - Short Form (BPI-SF)
Measured: 12 weeks
Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
Measured: 12 weeks
Secondary outcomes (4)
Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)
As measured with the Chronic Pain Self-efficacy Scale (CPSS)
Measured: 12 weeks
Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)
As measured with the Pain Knowledge Questionnaire (PKQ)
Measured: 12 weeks
Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)
As measured with the Hospital Anxiety and Depression Scale (HADS)
Measured: 12 weeks
Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)
As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (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 PainStudies of the same condition, open and under way.
- More trials run by Maastricht 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333968
- Sponsor's protocol ID
- UM 2011-5079
- Status last verified
- Jan 2015
- First submitted
- 29 Dec 2014
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hochstenbach LM, Courtens AM, Zwakhalen SM, van Kleef M, de Witte LP. Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol. BMC Cancer. 2015 May 19;15:416. doi: 10.1186/s12885-015-1428-1.
PubMed 25986294
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
- ClinicalTrials.gov ID
- NCT02333968
- Acronym / sponsor ID
- UM 2011-5079
- Conditions
- Pain
- Keywords
- Cancer pain, Self-management, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Atrium Medical Center
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 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.
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed. Important components include monitoring, feedback, education, and nurse support. Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use. Besides, a cost-evaluation and summative process evaluation will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Self-management supportSelf-management support |
| Control group | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of cancer
- Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
- Cancer (treatment related) pain > 2 weeks
- Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)
- Living at home
Key exclusion criteria (7 listed)
- Expected life expectancy < 3 months
- Chronic non-cancer pain
- Known cognitive impairments
- Participation in other studies that interfere with this study
- Not being able to read and understand the Dutch language
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 |
|---|---|---|
| Self-management supportThe 12-week intervention consists of an iPad application for patients that is connected to a web application for nurses. Every morning and evening patients register pain and related symptoms by use of a pain diary. Patients are also requested to register medication intake. Graphical feedback is provided based on registered pain scores and medication intakes. Patients receive education on causes and treatment of pain, symptoms that require action, and methods to better control pain. Patients communicate with nurses via text message functionality within the application. Specialized nurses remotely monitor and analyze the patients' situation once every workday. Nurses have the opportunity to collaborate with the treating physician, pain specialist or multidisciplinary team. | Behavioural | Intervention group |
Primary outcome
Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
Time frame: 12 weeks
As measured with the Brief Pain Inventory - Short Form (BPI-SF)
Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
Time frame: 12 weeks
As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
4 secondary outcomes
Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)
Time frame: 12 weeks
Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)
Time frame: 12 weeks
Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
- Derived from this study: PubMed 25986294Hochstenbach LM, Courtens AM, Zwakhalen SM, van Kleef M, de Witte LP. Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol. BMC Cancer. 2015 May 19;15:416. doi: 10.1186/s12885-015-1428-1.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management support in people with Pain, run by Maastricht University Medical Center at 2 sites 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 5 inclusion and 7 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Laura Hochstenbach, MSc (+31 433881691, l.hochstenbach@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF) (time frame: 12 weeks). 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 NCT02333968, 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 8 Jan 2015.