CancerPREFERENCENCT03705052
Patient's and Caregiver's Expectations and Preferences Concerning Art Therapy Activities for Cancer Support
A study testing Questionnaire in people with Cancer and Psychological Distress, run by General Hospital Groeninge at 1 site in Belgium.
Trial summary
Cancer patients and their caregivers often experience difficulties in coping with the cancer diagnosis and the treatment that follows. Creative art therapy could support cancer patients and their caregivers in coping with these issues by using their creativity and self-expression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Psychological Distress
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteBelgium
- Study dates
- 22 May 2018to 22 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dutch speaking patients and caregivers
- Patients and caregivers presenting at the outpatient clinic, including the day-care clinic and follow up visits
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient's and Caregiver's Expectations and Preferences Concerning Art Therapy Activities for Cancer Support in Light of Founding an Art Therapy Centre
Cancer patients and their caregivers often experience difficulties in coping with the cancer diagnosis and the treatment that follows. Creative art therapy could support cancer patients and their caregivers in coping with these issues by using their creativity and self-expression. The aim of this study for the investigator's research team is to create a clear image of what cancer patients and their caregivers expect of supportive care to help them coping with cancer diagnosis, cancer therapy and life after cancer. This is a prospective, interventional study. Cancer patients and their caregivers will be approached to participate in this study. They will be asked to complete a questionnaire about their satisfaction with the current support they get to help them coping with cancer diagnosis, cancer therapy and life after cancer and whether they would like to participate in an art therapy program, which art therapy forms they would like to participate in, how they would like them to be organized, etc.
- Conditions
- Cancer, Psychological Distress
- Being tested
- Questionnaire
- Keywords
- Art therapy, surveys and questionnaires, patient, caregiver
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients and caregivers were asked to complete a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Patients and caregivers were asked to complete a questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: At study inclusion
Secondary outcomes (3)
Activities of interest assessed by questionnary
Measured: At study inclusion
Preference on organization of activities evaluated by questionnary
Measured: At study inclusion
Patient or caregiver characteristics (sex, age, diagnosis) collected by questionnary
Measured: At study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start22 May 2018
- Primary completion22 Jun 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Philip Debruyne, General Hospital Groeninge
- Investigators
- Philip Derbuyne, MD, PhD, MSc, FRCP, Principal investigator, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705052
- Sponsor's protocol ID
- AZGS2018026
- Acronym
- PREFERENCE
- Status last verified
- Oct 2018
- First submitted
- 24 Sep 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visser A, Op 't Hoog M. Education of creative art therapy to cancer patients: evaluation and effects. J Cancer Educ. 2008;23(2):80-4. doi: 10.1080/08858190701821204.
PubMed 18569242Geue K, Goetze H, Buttstaedt M, Kleinert E, Richter D, Singer S. An overview of art therapy interventions for cancer patients and the results of research. Complement Ther Med. 2010 Jun-Aug;18(3-4):160-70. doi: 10.1016/j.ctim.2010.04.001. Epub 2010 May 15.
PubMed 20688262Bar-Sela G, Atid L, Danos S, Gabay N, Epelbaum R. Art therapy improved depression and influenced fatigue levels in cancer patients on chemotherapy. Psychooncology. 2007 Nov;16(11):980-4. doi: 10.1002/pon.1175.
PubMed 17351987Walsh SM, Martin SC, Schmidt LA. Testing the efficacy of a creative-arts intervention with family caregivers of patients with cancer. J Nurs Scholarsh. 2004;36(3):214-9. doi: 10.1111/j.1547-5069.2004.04040.x.
PubMed 15495489
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's and Caregiver's Expectations and Preferences Concerning Art Therapy Activities for Cancer Support in Light of Founding an Art Therapy Centre
- ClinicalTrials.gov ID
- NCT03705052
- Acronym / sponsor ID
- PREFERENCE / AZGS2018026
- Conditions
- Cancer, Psychological Distress
- Keywords
- Art therapy, surveys and questionnaires, patient, caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 15 Oct 2018 (actual)
- 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.
Cancer patients and their caregivers often experience difficulties in coping with the cancer diagnosis and the treatment that follows. Creative art therapy could support cancer patients and their caregivers in coping with these issues by using their creativity and self-expression. The aim of this study for the investigator's research team is to create a clear image of what cancer patients and their caregivers expect of supportive care to help them coping with cancer diagnosis, cancer therapy and life after cancer. This is a prospective, interventional study. Cancer patients and their caregivers will be approached to participate in this study. They will be asked to complete a questionnaire about their satisfaction with the current support they get to help them coping with cancer diagnosis, cancer therapy and life after cancer and whether they would like to participate in an art therapy program, which art therapy forms they would like to participate in, how they would like them to be organized, etc.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: QuestionnairePatients and caregivers were asked to complete a questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dutch speaking patients and caregivers
- Patients and caregivers presenting at the outpatient clinic, including the day-care clinic and follow up visits
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 |
|---|---|---|
| QuestionnairePatients and caregivers were asked to complete a questionnaire | Other | Intervention |
Primary outcome
Response rate
Time frame: At study inclusion
3 secondary outcomes
Activities of interest assessed by questionnary
Time frame: At study inclusion
Preference on organization of activities evaluated by questionnary
Time frame: At study inclusion
Patient or caregiver characteristics (sex, age, diagnosis) collected by questionnary
Time frame: At study inclusion
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 15 Oct 2018.
- Background: PubMed 18569242Visser A, Op 't Hoog M. Education of creative art therapy to cancer patients: evaluation and effects. J Cancer Educ. 2008;23(2):80-4. doi: 10.1080/08858190701821204.
- Background: PubMed 20688262Geue K, Goetze H, Buttstaedt M, Kleinert E, Richter D, Singer S. An overview of art therapy interventions for cancer patients and the results of research. Complement Ther Med. 2010 Jun-Aug;18(3-4):160-70. doi: 10.1016/j.ctim.2010.04.001. Epub 2010 May 15.
- Background: PubMed 17351987Bar-Sela G, Atid L, Danos S, Gabay N, Epelbaum R. Art therapy improved depression and influenced fatigue levels in cancer patients on chemotherapy. Psychooncology. 2007 Nov;16(11):980-4. doi: 10.1002/pon.1175.
- Background: PubMed 15495489Walsh SM, Martin SC, Schmidt LA. Testing the efficacy of a creative-arts intervention with family caregivers of patients with cancer. J Nurs Scholarsh. 2004;36(3):214-9. doi: 10.1111/j.1547-5069.2004.04040.x.
- Individual participant dataSharing planned: No
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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.
Philip Derbuyne, MD, PhD, MSc, FRCP principal investigator
General Hospital Groeninge
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 in people with Cancer and Psychological Distress, run by General Hospital Groeninge 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 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: finished, as of the sponsor's last update on 15 Oct 2018. 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?
Response rate (time frame: At study inclusion). 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 NCT03705052, which also lists 4 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 15 Oct 2018.