Complementary Alternative MedicineCAMNCT03747172
Use of CAM by Hospice Oncology Patients During Ambulatory Palliative Care
An observational study of Complementary Alternative Medicine and Complementary Alternative Therapy, run by Silesian University of Medicine at 1 site in Poland.
Trial summary
The aim of the study is to assess Prevalence of complementary and alternative therapy use by adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complementary Alternative Medicine, Complementary Alternative Therapy, Hospice Care
- What is being tested?
- complementary and alternative therapy
- How many people
- 1,004 participants
- Where
- 1 sitePoland
- Study dates
- 12 Jun 2018to 12 Sep 2018
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018
Who may be able to join
- adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018
Who cannot join
- Patients were excluded from the survey if they presented cognitive disturbances disabling credible answers in the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Complementary and Alternative Medicine by Hospice Oncology Patients During Ambulatory Palliative Care
The aim of the study is to assess Prevalence of complementary and alternative therapy use by adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018
Read the detailed description
The research team developed the CAT (complementary and alternative therapy) screening tool to obtain information about CAM use from patients. The screening tool was based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. CAT were grouped into five main categories: (1) biologically based therapies , (2) mind/body therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5) alternative medical systems.
The questionaire was tailored to meet the objectives of this study and to be adjusted to hospice patients specifics. It was piloted on the group of 25 patients, resulting in some vocabulary changes. The final questionnaire consists of 25 multiple-choice, semi-structured questions and takes about 15 min to complete. For each general CAM category the detailed information was collected on the type of specific therapy that was used. Patients were considered as CAM users if they have used at least one therapy from at least one of the categories during the period of 12 months prior to the screening. Patients were asked to specify the reasons for CAT usage, experienced effects of the therapy, stage at which patients considered using CAM
- Being tested
- complementary and alternative therapy
- Keywords
- complementary alternative medicine, cancer, complementary alternative therapy, hospice care, palliative care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complementary and alternative therapyDietary supplement
complementary and alternative therapies were grouped into five main categories: (1) biologically based therapies , (2) mind/body therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5) alternative medical systems.
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of prevalence of complementary and alternative therapy use by hospice patients
Presence and quantity of patients using any CAM therapies -The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Measured: 14 months
Variation of prevalence of biologically based therapies
Presence and quantity of patients using biologically based therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Measured: 14 months
Variation of prevalence of mind/body therapies
Presence and quantity of patients using mind/body therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Measured: 14 months
Variation of prevalence of manipulative and body-based therapies
Presence and quantity of patients using manipulative and body-based therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Measured: 14 months
Variation of prevalence of biologically Energy therapies
Presence and quantity of patients using Energy therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Measured: 14 months
Variation of prevalence of alternative medical systems
Presence and quantity of patients using alternative medical systems - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start12 Jun 2018
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complementary Alternative MedicineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silesian University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Pietrzyński, Silesian University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747172
- Sponsor's protocol ID
- CAM001
- Acronym
- CAM
- Status last verified
- Nov 2018
- First submitted
- 23 Oct 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Complementary and Alternative Medicine by Hospice Oncology Patients During Ambulatory Palliative Care
- ClinicalTrials.gov ID
- NCT03747172
- Acronym / sponsor ID
- CAM / CAM001
- Keywords
- complementary alternative medicine, cancer, complementary alternative therapy, hospice care, palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Silesian University of MedicineUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 20 Nov 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.
The aim of the study is to assess Prevalence of complementary and alternative therapy use by adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018
Detailed description
The research team developed the CAT (complementary and alternative therapy) screening tool to obtain information about CAM use from patients. The screening tool was based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. CAT were grouped into five main categories: (1) biologically based therapies , (2) mind/body therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5) alternative medical systems.
The questionaire was tailored to meet the objectives of this study and to be adjusted to hospice patients specifics. It was piloted on the group of 25 patients, resulting in some vocabulary changes. The final questionnaire consists of 25 multiple-choice, semi-structured questions and takes about 15 min to complete. For each general CAM category the detailed information was collected on the type of specific therapy that was used. Patients were considered as CAM users if they have used at least one therapy from at least one of the categories during the period of 12 months prior to the screening. Patients were asked to specify the reasons for CAT usage, experienced effects of the therapy, stage at which patients considered using CAM
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018
Key inclusion criteria (1 listed)
- adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care between July 2017 and September 2018
Key exclusion criteria (1 listed)
- Patients were excluded from the survey if they presented cognitive disturbances disabling credible answers in the questionnaire
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 |
|---|---|---|
| complementary and alternative therapycomplementary and alternative therapies were grouped into five main categories: (1) biologically based therapies , (2) mind/body therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5) alternative medical systems. | Dietary supplement | – |
Primary outcome
Variation of prevalence of complementary and alternative therapy use by hospice patients
Time frame: 14 months
Presence and quantity of patients using any CAM therapies -The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Variation of prevalence of biologically based therapies
Time frame: 14 months
Presence and quantity of patients using biologically based therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Variation of prevalence of mind/body therapies
Time frame: 14 months
Presence and quantity of patients using mind/body therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Variation of prevalence of manipulative and body-based therapies
Time frame: 14 months
Presence and quantity of patients using manipulative and body-based therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Variation of prevalence of biologically Energy therapies
Time frame: 14 months
Presence and quantity of patients using Energy therapies - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
Variation of prevalence of alternative medical systems
Time frame: 14 months
Presence and quantity of patients using alternative medical systems - The research team developed the CAT screening tool based on a The National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM. Questionnaire consists of 25 multiple-choice, semi-structured questions and gives the result in the form of a percentage
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 20 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complementary Alternative Medicine and Complementary Alternative Therapy, run by Silesian University of Medicine at 1 site in Poland.
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 1 inclusion and 1 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 20 Nov 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 Poland. 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?
Variation of prevalence of complementary and alternative therapy use by hospice patients (time frame: 14 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2018.