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Integrative Oncology for Patient Symptoms

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ClinicalTrials.gov Identifier: NCT04940780
Recruitment Status : Recruiting
First Posted : June 28, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Noah Samuels, Shaare Zedek Medical Center

Brief Summary:

The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.

A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).


Condition or disease Intervention/treatment Phase
Oncologic Complications Symptoms and Signs Other: Acupuncture Other: Touch Therapies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient-preference, pragmatic methodology
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Active Comparator: Patient Preference Arm
patients who specify their preference for either acupuncture or touch therapy
Other: Acupuncture
Acupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms

Other: Touch Therapies
Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Active Comparator: Randomized Treatment Arm
with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup
Other: Acupuncture
Acupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms

Other: Touch Therapies
Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch




Primary Outcome Measures :
  1. EORTC QLQ-C30 global health status / QoL scale [ Time Frame: 8 weeks ]
    Change from baseline to the end of the 8-week integrative treatment program


Secondary Outcome Measures :
  1. EORTC QLQ-C30 global health status / QoL scale [ Time Frame: 16 weeks ]
    Change from baseline and 8-week assessment to 16 week follow-up

  2. EORTC QLQ-C30 - additional outcomes [ Time Frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment ]
    Change in functional and symptom scores

  3. ESAS symptom severity scores [ Time Frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment ]
    Change in severity scores for 10 quality-of life related items

  4. MYCAW symptom severity scores [ Time Frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment ]
    Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives

  5. Frequency of adverse effects [ Time Frame: At the end of the series of 8 weekly CIM treatment sessions (≤ 2 weeks after the last treatment session); after 16 weeks from baseline. ]
    Any reported adverse events taking place during the study period which are considered to have possibly/probably resulted from the CIM intervention

  6. Adherence to conventional oncology treatment regimen [ Time Frame: At 16 weeks from baseline. ]
    Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation

  7. Caregiver expectations [ Time Frame: At baseline ]
    Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • undergoing active oncology treatment
  • fully understand the study plan
  • agree to sign the study informed consent form.

Exclusion Criteria:

  • not fulfilling all of the study criteria
  • not interested in attending all 8 weekly CIM treatments sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04940780


Contacts
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Contact: Noah Samuels, M.D. 972-26666395 noahs@szmc.org.il

Locations
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Israel
Institute of Oncology, Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 7791031
Contact: Noah Samuels, M.D.    026666395    noahs@szmc.org.il   
Sub-Investigator: Nathan Cherny, M.D.         
Sponsors and Collaborators
Shaare Zedek Medical Center
Publications:
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Responsible Party: Noah Samuels, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT04940780    
Other Study ID Numbers: INTEGR.ONCOL.REGIST-2021
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noah Samuels, Shaare Zedek Medical Center:
Integrative medicine
Integrative oncology
Acupuncture
Touch therapy
Wellbeing
Additional relevant MeSH terms:
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Neoplasms