Acute Myeloid LeukemiaNCT02863302
Reflexology: An Intervention for Acute Myeloid Leukemia(AML) Patients
A study testing Reflexology treatment in people with Acute Myeloid Leukemia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia. within the context of conventional medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Reflexology treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of AML
- chemotherapy treatment
- signing a consent form.
Who cannot join
- Not willing to sign a consent form.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 31096
Neatanel A Horowitz, MD, 97247772541, n_horowitz@rambam.health.gov.il
Limor Dan, 97247772541, l_dan@rambam.health.gov.il
About this study
Official title: Reflexology Treatment for Newly Diagnosed AML Patients, Can it Reduce GI Tract Side Effects, and Improve and Improve Patients Mood.
The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia. within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); by a specific questionnaire. 3) chemotherapy side effects associated with the digestive system.
Read the detailed description
The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia within the context of conventional medical care. This open study will test a one group design in which participants will continue to receive conventional care. All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.
The specific aims are: 1) to evaluate the effect of reflexology treatment on chemotherapy side effects effecting the digestive system. 2) to evaluate the effect of reflexology treatment on Quality of life. The assessment of the treatment will be executed on the FACIT-D VERSION 3.The influences of the treatment will also be evaluated by the nursing staff, in order to describe the patient's mental health and the condition of his intestinal movement.The side effect before during and after the chemotherapy treatment will be compared using the questionnaire.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Reflexology treatment
- Keywords
- Acute Myeloid Leukemia, Reflexology
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology treatmentOther
All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology treatment | Experimental | All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment until the end of hospitalization. Receives: Other: Reflexology treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the FACIT-D questionaire.
Measured: Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.
Secondary outcomes (1)
To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea
Diarrhea frequency will be recorded daily by the nursing staff and entered into the patients medical chart.
Measured: Diarrhea frequency will be recorded daily from the first day of chemotherapy and up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start1 Jan 2017
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
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 Acute Myeloid LeukemiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Netanel Horowitz MD, Rambam Health Care Campus
- Investigators
- Netanel A Horowitz, MD, Principal investigator, Rambam Health Care Campus, Haifa, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863302
- Sponsor's protocol ID
- 0107-16
- Status last verified
- Feb 2017
- First submitted
- 10 Jul 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahbar MH, Wyatt G, Sikorskii A, Victorson D, Ardjomand-Hessabi M. Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial. Contemp Clin Trials. 2011 Sep;32(5):620-9. doi: 10.1016/j.cct.2011.05.015. Epub 2011 Jun 2.
PubMed 21664296Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe.
PubMed 19918155
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflexology Treatment for Newly Diagnosed AML Patients, Can it Reduce GI Tract Side Effects, and Improve and Improve Patients Mood.
- ClinicalTrials.gov ID
- NCT02863302
- Acronym / sponsor ID
- 0107-16
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Reflexology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Aug 2016 (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 test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia. within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); by a specific questionnaire. 3) chemotherapy side effects associated with the digestive system.
Detailed description
The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia within the context of conventional medical care. This open study will test a one group design in which participants will continue to receive conventional care. All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.
The specific aims are: 1) to evaluate the effect of reflexology treatment on chemotherapy side effects effecting the digestive system. 2) to evaluate the effect of reflexology treatment on Quality of life. The assessment of the treatment will be executed on the FACIT-D VERSION 3.The influences of the treatment will also be evaluated by the nursing staff, in order to describe the patient's mental health and the condition of his intestinal movement.The side effect before during and after the chemotherapy treatment will be compared using the questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reflexology treatment | Experimental | Other: Reflexology treatmentAll patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment until the end of hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of AML
- chemotherapy treatment
- signing a consent form.
Key exclusion criteria (1 listed)
- Not willing to sign a consent form.
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 |
|---|---|---|
| Reflexology treatmentAll patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment. | Other | Reflexology treatment |
Primary outcome
Change from baseline in the FACIT-D questionaire.
Time frame: Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.
1 secondary outcome
To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea
Time frame: Diarrhea frequency will be recorded daily from the first day of chemotherapy and up to 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Results publication: PubMed 21664296Rahbar MH, Wyatt G, Sikorskii A, Victorson D, Ardjomand-Hessabi M. Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial. Contemp Clin Trials. 2011 Sep;32(5):620-9. doi: 10.1016/j.cct.2011.05.015. Epub 2011 Jun 2.
- Results publication: PubMed 19918155Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe.
- 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.
Netanel A Horowitz, MD principal investigator
Rambam Health Care Campus, Haifa, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology treatment in people with Acute Myeloid Leukemia, run by Rambam Health Care Campus at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Israel. 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 Netanel A Horowitz, MD (97247772541, n_horowitz@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the FACIT-D questionaire. (time frame: Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.). 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 NCT02863302, 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 15 Feb 2017.