CancerOPSA-PKNCT02282696
Validation Study CARES
A study testing Questionnaire, focus group participation in people with Cancer, run by Hasselt University at 1 site in Belgium.
Trial summary
This study aims to validate the CARES, a needs assessment instrument which can be used to inventorize cancer patients biopsychosocial distress and care needs. QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package containing questions about social-demographic and medical data, the CARES and… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaire, focus group participation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Mar 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary cancer diagnosis stage I, II, III
- All types of cancer
Who cannot join
- Having had or premorbid neurological problems or cognitive dysfunctions.
- The lack of proficiency in Dutch (Flemish).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on Psychosocial Aspects in the Care for Patients With Cancer: Validation Study CARES.
This study aims to validate the CARES, a needs assessment instrument which can be used to inventorize cancer patients biopsychosocial distress and care needs.
- QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package containing questions about social-demographic and medical data, the CARES and convergent measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS), Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire package participants have to fill in the CARES a second time and answer some questions to evaluate the feasibility of the CARES.
- QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage can participate in a focus group interview. In these focus groups the content validity and preferences on psychosocial screening in care are discussed.
- Conditions
- Cancer
- Being tested
- Questionnaire, focus group participation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire, focus group participationOther
participants of the quantitative part of the study are asked to fill in a questionnaire, participants of the qualitative part are asked to participate in a focus group interview.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients | Experimental | Questionnaire, focus group participation Receives: Other: Questionnaire, focus group participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the CARES
CARES-total and subscale scores. Computation of internal consistency of summary scales (for reliability), intra-class correlation between test and retest scores (for reliability), confirmatory factor analysis (for construct-validity)
Measured: week 1
Convergent validity of the CARES
Total- and subscale scores of convergent instruments (KPS, HADS,SSL, MMQ, EORTC-QOL-C30, DT). Computation of correlation between CARES-scores and scores of convergent instruments.
Measured: week 1
Secondary outcomes (2)
To assess the distress and care needs of cancer patients
inventorization of level of distress, number and kind of difficulties and care needs experienced by cancer patients
Measured: week 1
To assess patients experiences with psychosocial care
Patients experiences of the approach of psychosocial wellbeing in cancer care, and their preferences in this area.
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionMar 2015
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 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, KU Leuven
- Responsible party
- Principal investigator, Johan Hellings, Hasselt University
- Investigators
- Hellings Johan, Principal investigator, Hasselt UniversityBojoura Schouten, dra., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282696
- Sponsor's protocol ID
- OPSA-PK
- Acronym
- OPSA-PK
- Status last verified
- Aug 2017
- First submitted
- 16 Jul 2014
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Schouten B, Hellings J, Van Hoof E, Vankrunkelsven P, Bulens P, Buntinx F, Mebis J, Vandijck D, Schrooten W. Validation of the flemish CARES, a quality of life and needs assessment tool for cancer care. BMC Cancer. 2016 Aug 30;16(1):696. doi: 10.1186/s12885-016-2728-9.
PubMed 27576341Schouten B, Van Hoof E, Vankrunkelsven P, Schrooten W, Bulens P, Buntinx F, Mebis J, Vandijck D, Cleemput I, Hellings J. Assessing cancer patients' quality of life and supportive care needs: Translation-revalidation of the CARES in Flemish and exhaustive evaluation of concurrent validity. BMC Health Serv Res. 2016 Mar 11;16:86. doi: 10.1186/s12913-016-1335-4.
PubMed 26969509
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Psychosocial Aspects in the Care for Patients With Cancer: Validation Study CARES.
- ClinicalTrials.gov ID
- NCT02282696
- Acronym / sponsor ID
- OPSA-PK / OPSA-PK
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, KU Leuven
- Study start
- Jan 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Nov 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.
This study aims to validate the CARES, a needs assessment instrument which can be used to inventorize cancer patients biopsychosocial distress and care needs.
- QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package containing questions about social-demographic and medical data, the CARES and convergent measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS), Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire package participants have to fill in the CARES a second time and answer some questions to evaluate the feasibility of the CARES.
- QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage can participate in a focus group interview. In these focus groups the content validity and preferences on psychosocial screening in care are discussed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients | Experimental | Other: Questionnaire, focus group participationQuestionnaire, focus group participation |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primary cancer diagnosis stage I, II, III
- All types of cancer
Key exclusion criteria (2 listed)
- Having had or premorbid neurological problems or cognitive dysfunctions.
- The lack of proficiency in Dutch (Flemish).
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 |
|---|---|---|
| Questionnaire, focus group participationparticipants of the quantitative part of the study are asked to fill in a questionnaire, participants of the qualitative part are asked to participate in a focus group interview. | Other | cancer patients |
Primary outcome
Validity of the CARES
Time frame: week 1
CARES-total and subscale scores. Computation of internal consistency of summary scales (for reliability), intra-class correlation between test and retest scores (for reliability), confirmatory factor analysis (for construct-validity)
Convergent validity of the CARES
Time frame: week 1
Total- and subscale scores of convergent instruments (KPS, HADS,SSL, MMQ, EORTC-QOL-C30, DT). Computation of correlation between CARES-scores and scores of convergent instruments.
2 secondary outcomes
To assess the distress and care needs of cancer patients
Time frame: week 1
To assess patients experiences with psychosocial care
Time frame: week 1
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 Sep 2017.
- Derived from this study: PubMed 27576341Schouten B, Hellings J, Van Hoof E, Vankrunkelsven P, Bulens P, Buntinx F, Mebis J, Vandijck D, Schrooten W. Validation of the flemish CARES, a quality of life and needs assessment tool for cancer care. BMC Cancer. 2016 Aug 30;16(1):696. doi: 10.1186/s12885-016-2728-9.
- Derived from this study: PubMed 26969509Schouten B, Van Hoof E, Vankrunkelsven P, Schrooten W, Bulens P, Buntinx F, Mebis J, Vandijck D, Cleemput I, Hellings J. Assessing cancer patients' quality of life and supportive care needs: Translation-revalidation of the CARES in Flemish and exhaustive evaluation of concurrent validity. BMC Health Serv Res. 2016 Mar 11;16:86. doi: 10.1186/s12913-016-1335-4.
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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.
Hellings Johan principal investigator
Hasselt University
Bojoura Schouten, dra. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire, focus group participation in people with Cancer, run by Hasselt University at 1 site in Belgium.
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 2 inclusion and 2 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 Sep 2017. 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 Belgium. 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?
Validity of the CARES (time frame: week 1). 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 NCT02282696, 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 Sep 2017.