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Quality of LifeNCT01860365

Measuring Concerns of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within Oncology Service

A study testing Complementary medicine consultation and treatment and Patients receiving conventional supportive care in people with Quality of Life, run by Carmel Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS established the Integrative Oncology Program with the goal of addressing patient concerns and improving quality of life parameters… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life
What is being tested?
Complementary medicine consultation and treatment and Patients receiving conventional supportive care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
1 siteIsrael
Study dates
Jul 2009to 1 Sep 2025
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

  • Patients with cancer diagnosis receiving chemotherapy and/or surgical treatment who are referred by their oncology provider to complementary medicine consultation
  • Age older than 18 years

Who cannot join

  • Age younger than 18 years

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting

  • Lin Zebulon and Carmel Medical centers

    Haifa, 35152

    Eran Ben-Arye, MD, 972528709282 ext. 0, eranbe@clalit.org.il

    Ilanit Shalom-Sharabi, RN MA, 97252948423 ext. 0, ilanitsh10@walla.co.il

    Recruiting

Other trials in Israel

About this study

Official title: Measuring Concerns and Needs of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within the Oncology Service

In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS established the Integrative Oncology Program with the goal of addressing patient concerns and improving quality of life parameters during chemotherapy and advanced disease. The study hypothesis is that integrated medicine consultation and treatment provided within the oncology department may improve patients' concerns and well-being.

Read the detailed description

In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS established the Integrative Oncology Program with the goal of addressing patient concerns and improving quality of life parameters during chemotherapy and advanced disease. The study is purposed to assess concerns, needs and perspectives of patients referred to integrative consultation during chemotherapy and/or advanced cancer; to characterize social demographic and health parameters of patients who consult or avoid integrative medicine consultation; to document complementary medicine use prior and during consultation; to assess if complementary medicine consultation and treatment improve patient's concerns and well-being; and to assess oncology provider and integrative practitioner communications issues concerning integrative care.

Conditions
Quality of Life
Being tested
Complementary medicine consultation and treatment, Patients receiving conventional supportive care
Keywords
Quality of life, Integrative medicine, Supportive care, Cancer, Chemotherapy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complementary medicine consultation and treatmentOther

    Patients receiving chemotherapy will be referred by their oncology provider to complementary medicine (CM) consultation and treatment provided in addition to conventional supportive care.CM consultation will include assessment of patients' concerns and well-being, current CM use (including herbal and nutritional supplements), and construction of CM treatment based on efficacy and safety considerations.

  • Patients receiving conventional supportive careOther

    Patients receiving chemotherapy will be offered assessment of their concerns and well-being as well as their current complementary medicine (CM) use (including herbal and nutritional supplements). Patients in this arm study will receive conventional supportive care with no added CM consultation or treatment.

Study groups in NCT01860365
Study groupRoleWhat they receive
Complementary medicine counselingExperimentalPatients receiving chemotherapy who are referred by their oncology provider to complementary medicine consultation and treatment provided in addition to conventional supportive care
Receives: Other: Complementary medicine consultation and treatment
Conventional supportive careActive comparatorPatients receiving conventional supportive care
Receives: Other: Patients receiving conventional supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MYCAW (Measure Yourself Concerns and Wellbeing)questionnaire

    Assessing patients'concerns and Wellbeing as well as narrative assessment of integrative care outcomes

    Measured: 6-12 weeks(+follow-up 4 months)

  2. ESAS (Edmonton Symptom Assessment Scale)questionnaire

    Assessing the severity of 10 leading symptoms and well-being

    Measured: 6-12 weeks(+follow-up 4 months)

  3. EORTC QLQ-C30

    The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health related quality of life of cancer patients. The questionnaire includes functional and symptom scales.

    Measured: 6-12 weeks(+follow-up 4 months)

Secondary outcomes (2)

  1. FACIT-Sp-12 questionnaire

    Assessing patients' spiritual well-being

    Measured: 2-4 months

  2. Attitudes concerning complementary medicine

    Assessment of patients' attitudes concerning complementary medicine (CM)safety and efficacy, health beliefs concerning mind-body interactions, and willingness to receive CM treatments

    Measured: 6-12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2013 (estimated)
  2. Study startJul 2009
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860365
Sponsor's protocol ID
CMC-09-0024-CTIL
Status last verified
Feb 2024
First submitted
20 May 2013
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Kassem S, Gressel O, Samuels N, Stein N, Glaser B, Ben-Arye E. The impact of integrative medicine on quality of life in patients with diabetes mellitus and cancer. Support Care Cancer. 2026 Mar 17;34(4):335. doi: 10.1007/s00520-026-10511-6.

    PubMed 41843227

  • Ben-Arye E, Greenberg D, Samuels N, Lopez AM, Simon-Tuval T. Adherence to Integrative Care, Oncology Healthcare Utilization, Opioid Use and Hospitalization. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251387955. doi: 10.1177/15347354251387955. Epub 2025 Oct 28.

    PubMed 41147326

  • Ben-Arye E, Lopez AM, Daoud N, Zoller L, Walker E, Davidescu M, Shulman K, Gressel O, Stein N, Brosh S, Schiff E, Samuels N. Identifying Factors Associated With Disparities in Access to Integrative Oncology Program. J Pain Symptom Manage. 2024 Jul;68(1):10-21. doi: 10.1016/j.jpainsymman.2024.03.018. Epub 2024 Mar 27.

    PubMed 38552747

  • Hauzer M, Grimberg R, Samuels N, Keshet Y, Mordechai A, Dagash J, Ben-Arye E. Exploring primary care physician feedback following an integrative oncology consultation. Support Care Cancer. 2023 Oct 3;31(10):606. doi: 10.1007/s00520-023-08079-6.

    PubMed 37787815

  • Ben-Arye E, Elly M, Gressel O, Reshef A, Shani Md M, Stein N, Saliba W, Samuels N. Exploring the effectiveness of a patient-tailored integrative oncology program on emotional distress during chemotherapy for localized cancer. Psychooncology. 2022 Feb;31(2):207-218. doi: 10.1002/pon.5794. Epub 2021 Aug 26.

    PubMed 34435403

  • Kerner H, Samuels N, Ben Moshe S, Sharabi IS, Ben-Arye E. Impact of a patient-tailored complementary/integrative medicine programme on disturbed sleep quality among patients undergoing chemotherapy. BMJ Support Palliat Care. 2020 Sep;10(3):e21. doi: 10.1136/bmjspcare-2017-001351. Epub 2017 Jul 14.

    PubMed 28710110

  • Sharabi IS, Levin A, Schiff E, Samuels N, Agour O, Tapiro Y, Lev E, Keinan-Boker L, Ben-Arye E. Quality of life-related outcomes from a patient-tailored integrative medicine program: experience of Russian-speaking patients with cancer in Israel. Support Care Cancer. 2016 Oct;24(10):4345-55. doi: 10.1007/s00520-016-3274-3. Epub 2016 May 11.

    PubMed 27169571

  • Ben-Arye E, Keshet Y, Shahbar IM, Aharonson ML, Preis L, Agour O, Schiff E, Samuels N. The kitchen as therapy: qualitative assessment of an integrative cuisine workshop for patients undergoing chemotherapy. Support Care Cancer. 2016 Apr;24(4):1487-95. doi: 10.1007/s00520-015-2934-z. Epub 2015 Sep 11.

    PubMed 26361759

  • Ben-Arye E, Samuels N, Schiff E, Raz OG, Sharabi IS, Lavie O. Quality-of-life outcomes in patients with gynecologic cancer referred to integrative oncology treatment during chemotherapy. Support Care Cancer. 2015 Dec;23(12):3411-9. doi: 10.1007/s00520-015-2690-0. Epub 2015 Mar 10.

    PubMed 25752885

Questions about this trial

What is this clinical trial studying?

A study testing Complementary medicine consultation and treatment and Patients receiving conventional supportive care in people with 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 2 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 20 Feb 2024. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MYCAW (Measure Yourself Concerns and Wellbeing)questionnaire (time frame: 6-12 weeks(+follow-up 4 months)). The study lists 3 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 NCT01860365, which also lists 9 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 20 Feb 2024.

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