CancerNCT03676153
Integrative Care Training Program for Nurses on Supportive Cancer Care
A study testing Nurse-provided guidance and Integrative medicine treatment program in people with Cancer and Quality of Life, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The integration of complementary medicine in supportive and palliative cancer care (i.e., Integrative Oncology) is becoming more prevalent in many of the leading oncology centers in Israel and worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Quality of Life, Nurse's Role
- What is being tested?
- Nurse-provided guidance and Integrative medicine treatment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Nov 2018to 20 Mar 2022
- 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
- Oncology patients undergoing treatment within an adjuvant, neo-adjuvant, curative or palliative setting.
Who cannot join
- Patients who are unable to sign informed consent
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impact of an Integrative Care Training Program for Nurses in Manual Therapies, Relaxation, Lifestyle Changes and Traditional Medicine on Quality of Life in Oncology Patients: A Randomized Controlled Study
The integration of complementary medicine in supportive and palliative cancer care (i.e., Integrative Oncology) is becoming more prevalent in many of the leading oncology centers in Israel and worldwide. Guidelines for these practices, as established by the Society for Integrative Oncology, were adopted in 2018 by the American Society of Clinical Oncology.
The proposed study will be conducted within a pragmatic, randomized and controlled format, and will examine the impact of a nurse-guided intervention on 540 oncology patients undergoing Integrative Oncology treatments for quality of life (QOL)-related concerns during adjuvant/neo-adjuvant or curative/palliative treatments. Patients in both study arms will undergo patient-tailored integrative treatments, which will include manual and relaxation therapies, acupuncture and lifestyle changes. The integrative treatments will be provided by trained integrative oncology practitioners. Patients in the intervention arm of the study will receive additional nurse-guided instruction in the self-administration of manual therapies, relaxation, lifestyle changes and traditional medicine practices.
Read the detailed description
The integration of complementary medicine in supportive and palliative cancer care (i.e., Integrative Oncology) is becoming more prevalent in many of the leading oncology centers in Israel and worldwide. Guidelines for these practices, as established by the Society for Integrative Oncology, were adopted in 2018 by the American Society of Clinical Oncology.
The proposed study will be conducted within a pragmatic, randomized and controlled format, and will examine the impact of a nurse-guided intervention on 540 oncology patients undergoing Integrative Oncology treatments for quality of life (QOL)-related concerns during adjuvant/neo-adjuvant or curative/palliative treatments. Patients in both study arms will undergo patient-tailored integrative treatments, which will include manual and relaxation therapies, acupuncture and lifestyle changes. The integrative treatments will be provided by trained integrative oncology practitioners. Patients in the intervention arm of the study will receive additional nurse-guided instruction in the self-administration of manual therapies, relaxation, lifestyle changes and traditional medicine practices.
The primary study outcome will be the assessment of the impact of the integrative treatment (with vs. without the nurse-guided intervention) on patient QOL-related concerns, from baseline to 48 hours following the intervention. For this purpose, two patient-reported outcome measures (PROMs) will be administered: the Edmonton Symptom Assessment Scale (ESAS) and the Measure Yourself Concern and Wellbeing (MYCAW) questionnaire. Secondary outcome measures will include the need for medications for supportive/palliative care-related indications (pain, nausea, anxiety/depression, constipation/diarrhea, etc.); and the rates of referral of patients to the services provided by the supportive/palliative care service.
- Conditions
- Cancer, Quality of Life, Nurse's Role
- Being tested
- Nurse-provided guidance, Integrative medicine treatment program
- Keywords
- Integrative medicine, Supportive and 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.
Nurse-provided guidanceOther
Nurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.
Integrative medicine treatment programOther
Integrative medicine treatment program
| Study group | Role | What they receive |
|---|---|---|
| Nurse-guided arm | Experimental | Nurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine. Receives: Other: Nurse-provided guidance; Other: Integrative medicine treatment program |
| Non nurse-guided arm | Active comparator | Integrative medicine treatment program, with no nurse-provided guidance on patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine. Receives: Other: Integrative medicine treatment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Yourself Concerns and Wellbeing (MYCAW)
Scale from 0 (not bothering me at all) to 6 (bothers me greatly)
Measured: 48 hours
Secondary outcomes (1)
Edmonton Symptom Assessment Scale (ESAS)
Scale from 0 (no symptom) to 10 (worst possible symptom)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start15 Nov 2018
- Primary completion1 Feb 2022
- Study completion20 Mar 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic study examining the impact of a nurse-guided self-administered integrative medicine intervention on quality-of-life outcomes in cancer care.
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eran Ben-Arye, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676153
- Sponsor's protocol ID
- CMC-18-0139-CTIL
- Status last verified
- Mar 2022
- First submitted
- 13 Sep 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ben-Arye E, Shulman B, Eilon Y, Woitiz R, Cherniak V, Shalom Sharabi I, Sher O, Reches H, Katz Y, Arad M, Schiff E, Samuels N, Caspi O, Lev-Ari S, Frenkel M, Agbarya A, Admi H. Attitudes Among Nurses Toward the Integration of Complementary Medicine Into Supportive Cancer Care. Oncol Nurs Forum. 2017 Jul 1;44(4):428-434. doi: 10.1188/17.ONF.428-434.
PubMed 28632238Ben-Arye E, Tapiro Y, Baruch R, Tal A, Shulman B, Gressel O, Israeli P, Dagash J, Yosipovich A, Shalom Sharabi I, Zimmermann P, Samuels N. Integrative oncology for palliative care nurses: pre-post training evaluation. BMJ Support Palliat Care. 2024 May 17;14(2):178-182. doi: 10.1136/spcare-2022-004117.
PubMed 36690415
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of an Integrative Care Training Program for Nurses in Manual Therapies, Relaxation, Lifestyle Changes and Traditional Medicine on Quality of Life in Oncology Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03676153
- Acronym / sponsor ID
- CMC-18-0139-CTIL
- Conditions
- Cancer, Quality of Life, Nurse's Role
- Keywords
- Integrative medicine, Supportive and Palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 18 Sep 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 integration of complementary medicine in supportive and palliative cancer care (i.e., Integrative Oncology) is becoming more prevalent in many of the leading oncology centers in Israel and worldwide. Guidelines for these practices, as established by the Society for Integrative Oncology, were adopted in 2018 by the American Society of Clinical Oncology.
The proposed study will be conducted within a pragmatic, randomized and controlled format, and will examine the impact of a nurse-guided intervention on 540 oncology patients undergoing Integrative Oncology treatments for quality of life (QOL)-related concerns during adjuvant/neo-adjuvant or curative/palliative treatments. Patients in both study arms will undergo patient-tailored integrative treatments, which will include manual and relaxation therapies, acupuncture and lifestyle changes. The integrative treatments will be provided by trained integrative oncology practitioners. Patients in the intervention arm of the study will receive additional nurse-guided instruction in the self-administration of manual therapies, relaxation, lifestyle changes and traditional medicine practices.
Detailed description
The integration of complementary medicine in supportive and palliative cancer care (i.e., Integrative Oncology) is becoming more prevalent in many of the leading oncology centers in Israel and worldwide. Guidelines for these practices, as established by the Society for Integrative Oncology, were adopted in 2018 by the American Society of Clinical Oncology.
The proposed study will be conducted within a pragmatic, randomized and controlled format, and will examine the impact of a nurse-guided intervention on 540 oncology patients undergoing Integrative Oncology treatments for quality of life (QOL)-related concerns during adjuvant/neo-adjuvant or curative/palliative treatments. Patients in both study arms will undergo patient-tailored integrative treatments, which will include manual and relaxation therapies, acupuncture and lifestyle changes. The integrative treatments will be provided by trained integrative oncology practitioners. Patients in the intervention arm of the study will receive additional nurse-guided instruction in the self-administration of manual therapies, relaxation, lifestyle changes and traditional medicine practices.
The primary study outcome will be the assessment of the impact of the integrative treatment (with vs. without the nurse-guided intervention) on patient QOL-related concerns, from baseline to 48 hours following the intervention. For this purpose, two patient-reported outcome measures (PROMs) will be administered: the Edmonton Symptom Assessment Scale (ESAS) and the Measure Yourself Concern and Wellbeing (MYCAW) questionnaire. Secondary outcome measures will include the need for medications for supportive/palliative care-related indications (pain, nausea, anxiety/depression, constipation/diarrhea, etc.); and the rates of referral of patients to the services provided by the supportive/palliative care service.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic study examining the impact of a nurse-guided self-administered integrative medicine intervention on quality-of-life outcomes in cancer care.
| Arm | Type | Receives |
|---|---|---|
| Nurse-guided arm | Experimental | Other: Nurse-provided guidance, Other: Integrative medicine treatment programNurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine. |
| Non nurse-guided arm | Active comparator | Other: Integrative medicine treatment programIntegrative medicine treatment program, with no nurse-provided guidance on patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Oncology patients undergoing treatment within an adjuvant, neo-adjuvant, curative or palliative setting.
Key exclusion criteria (2 listed)
- Patients who are unable to sign informed consent
- Pregnant patients
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 |
|---|---|---|
| Nurse-provided guidanceNurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine. | Other | Nurse-guided arm |
| Integrative medicine treatment programIntegrative medicine treatment program | Other | Non nurse-guided arm, Nurse-guided arm |
Primary outcome
Measure Yourself Concerns and Wellbeing (MYCAW)
Time frame: 48 hours
Scale from 0 (not bothering me at all) to 6 (bothers me greatly)
1 secondary outcome
Edmonton Symptom Assessment Scale (ESAS)
Time frame: 24 hours
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 22 Mar 2022.
- Background: PubMed 28632238Ben-Arye E, Shulman B, Eilon Y, Woitiz R, Cherniak V, Shalom Sharabi I, Sher O, Reches H, Katz Y, Arad M, Schiff E, Samuels N, Caspi O, Lev-Ari S, Frenkel M, Agbarya A, Admi H. Attitudes Among Nurses Toward the Integration of Complementary Medicine Into Supportive Cancer Care. Oncol Nurs Forum. 2017 Jul 1;44(4):428-434. doi: 10.1188/17.ONF.428-434.
- Derived from this study: PubMed 36690415Ben-Arye E, Tapiro Y, Baruch R, Tal A, Shulman B, Gressel O, Israeli P, Dagash J, Yosipovich A, Shalom Sharabi I, Zimmermann P, Samuels N. Integrative oncology for palliative care nurses: pre-post training evaluation. BMJ Support Palliat Care. 2024 May 17;14(2):178-182. doi: 10.1136/spcare-2022-004117.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Nurse-provided guidance and Integrative medicine treatment program in people with Cancer and Quality of Life, run by Carmel Medical Center 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 1 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 22 Mar 2022. 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?
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?
Measure Yourself Concerns and Wellbeing (MYCAW) (time frame: 48 hours). 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 NCT03676153, 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 22 Mar 2022.