xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05982223</url>
    </required_header>
    <id_info>
      <org_study_id>0050-23-BNZ</org_study_id>
      <nct_id>NCT05982223</nct_id>
    </id_info>
    <brief_title>Integrative Medicine in Lymphoma Survivors</brief_title>
    <official_title>Effectiveness of Integrative Medicine Treatments in Lymphoma Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bnai Zion Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bnai Zion Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Lymphoma is a cancer of the lymph nodes. While some are &quot;silent&quot; and only require follow-up,&#xD;
        in cases of aggressive lymphoma, treatment is necessary, and usually includes biological&#xD;
        drugs, chemotherapy or both. These drugs often cause significant damage to quality-of-life&#xD;
        and various symptoms that do not always go away. Although the treatments are often limited in&#xD;
        time and with recovery rates over 60%, most patients are left with a significantly impaired&#xD;
        quality-of-life and difficulty in returning to their previous life. Many studies, most of&#xD;
        which were conducted in breast cancer survivors, show the place of complementary medicine in&#xD;
        the recovery process, both in terms of symptom relief and in improving quality-of-life. Few&#xD;
        studies have examined the place of complementary and integrative medicine in lymphoma&#xD;
        survivors. The purpose of the present study is to examine the effect of integrative&#xD;
        treatments (a combination of conventional and complementary medicine) on quality-of-life of&#xD;
        lymphoma survivors, on specific symptoms caused by the disease and its treatment, on economic&#xD;
        and social aspects, as well as on the course of the disease. At the hematological unit of&#xD;
        Bnai Zion Medical Center, Haifa, Israel, patients with lymphoma who have received&#xD;
        chemotherapy, biological treatment or both, and have been defined as recovering by the&#xD;
        treating hematologist, will be offered a choice of different types of complementary medicine&#xD;
        (acupuncture, herbal medicine, mind-body, movement and touch therapies), emotional treatment&#xD;
        (conversations with social worker, spiritual guidance), or both, in addition to the medical&#xD;
        and nursing care offered to all survivors. Patients who prefer not to come to the clinic for&#xD;
        these treatments will be assigned to the control group and will fill out questionnaires only.&#xD;
        The duration of the treatments will be six months and follow-up for another two years. The&#xD;
        type of treatments the patient will receive will be chosen in coordination between the&#xD;
        integrative team and the patient and according to the symptoms. An assessment will be made on&#xD;
        the effect of these treatments on quality-of-life of lymphoma survivors (based on&#xD;
        questionnaires), including physical, psycho-spiritual and economic aspects, as well as on the&#xD;
        course of the disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Lymphoma is a malignant disease of the lymph nodes. While some of the lymphomas&#xD;
        are indolent and require only follow-up, in cases of aggressive lymphoma or indolent lymphoma&#xD;
        with a high burden of disease, treatment is necessary and usually includes biological drugs,&#xD;
        chemotherapy or both. These drugs often cause significant damage to quality-of-life,&#xD;
        including various symptoms such as fatigue, gastrointestinal symptoms, neuropathy, as well as&#xD;
        psycho-emotional and financial damage surrounding the cessation of work during the&#xD;
        treatments. Although the treatments are often limited in time and with recovery rates above&#xD;
        60% in the case of aggressive lymphoma, most patients are left with a significant impairment&#xD;
        in the quality-of-life and difficulty in returning to the life before the disease. Survivor&#xD;
        clinics are usually located outside the oncology clinics and are designed to help cancer&#xD;
        patients return to life after they have recovered from the disease. Many studies, mostly in&#xD;
        breast cancer survivors, show the place of complementary medicine in the recovery process,&#xD;
        both in terms of relieving symptoms and improving quality-of-life. Few studies have examined&#xD;
        the place of complementary medicine in survivor clinics in haemato-oncological patients after&#xD;
        intensive and time-limited treatments. In addition, integrative oncology that incorporates&#xD;
        both conventional and complementary medicine, is a developing discipline that has been shown&#xD;
        to be effective in the relief of many cancer-related symptoms such as chemotherapy-induced&#xD;
        peripheral neuropathy, which is common in lymphoma survivors, and other outcomes such as&#xD;
        quality-of-life, or even survival.&#xD;
  &#xD;
        Hypothesis: In the present study, we assumed that an integrative oncology approach was&#xD;
        effective for improving different outcomes of lymphoma survivors including quality-of-life,&#xD;
        specific symptoms caused by the disease and its treatment, economic and social aspects, as&#xD;
        well as the course of the disease.&#xD;
  &#xD;
        Study plan: At the Hematology Unit at Bnai Zion Hospital, adult lymphoma survivors that&#xD;
        received chemotherapy, biologic therapy or both during active lymphoma treatment, and are&#xD;
        willing to participate in the study, will be recruited up to one year after remission. After&#xD;
        completing questionnaires and an initial assessment by the integrative team, the patients&#xD;
        will be divided by preference between the control group who will receive the mandatory basic&#xD;
        treatment for follow-up after the disease (medical and nursing); and the intervention group&#xD;
        who will come to the clinic and receive, in addition to the above, emotional treatments&#xD;
        (counseling, spiritual guidance), complementary medicine (acupuncture, herbal supplements,&#xD;
        mind-body, touch and/or movement therapies) or both. The type and frequency of complementary&#xD;
        therapy will be chosen by the integrative team in coordination with the patient, based on&#xD;
        patient's symptoms and preferences. The duration of the intervention will be 6 months from&#xD;
        recruitment. During follow-up, the patients will fill-out a MYCAW questionnaire to assess&#xD;
        symptoms in each treatment (or once a month in the control group) and a safety assessment&#xD;
        will be performed using the validated Acupuncture-Adverse Events (Acup-AE) questionnaire for&#xD;
        acupuncture or targeted questioning for other treatments. Also, the patients will fill-out&#xD;
        quality-of-life questionnaires once a month and economic and cognitive evaluation&#xD;
        questionnaires once every 3 months. The haemato-oncologist will complete an assessment of the&#xD;
        disease state once every 3 months. In addition, 3 months after the end of the treatments, the&#xD;
        patients will fill-out all the same questionnaires for follow-up. The haemato-oncologist will&#xD;
        perform a medical follow-up on the condition of the disease once every 3 months for two years&#xD;
        from the end of the treatments at the survivor clinic.&#xD;
  &#xD;
        The primary outcome is the effect of an integrative approach on quality-of-life of lymphoma&#xD;
        survivors. Secondary outcomes include the effect of such approach on specific symptoms caused&#xD;
        by the disease and its treatment, economic and social aspects, as well as on the course of&#xD;
        the disease.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">July 2028</completion_date>
    <primary_completion_date type="Anticipated">July 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Preference-based comparative effectiveness clinical trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Quality-of-life by EQ-5D scale</measure>
      <time_frame>Through study completion: an average of 1 year</time_frame>
      <description>EQ-5D scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Symptom relief</measure>
      <time_frame>Through study completion: an average of 1 year</time_frame>
      <description>Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive functions</measure>
      <time_frame>Through study completion: an average of 1 year</time_frame>
      <description>Functional Assessment of Cancer Therapy - cognitive (FACT-cog) questionnaire: evaluates perceived cognitive functioning and their impact on quality of life. This is a self-reported 37-item questionnaire that consists of four subscales: Perceived Cognitive Impairment (CogPCI) (20 items), Perceived Cognitive Ability (CogPCA) (9 items), Comments from Others on Cognitive Function (Cog-Oth) (4 items), and Impact on Quality of Life (Cog-QoL) (4 items). All items are rated for the previous week, including the day of administration, on a 5-point Likert scale ranging from 0 &quot;Never&quot; or &quot;Not at all&quot; to 4 &quot;Several times a day&quot; or &quot;Very much&quot;. The total CogPCI subscale ranges from 0 to 72, the CogPCA ranges between 0 and 28, and each of the Cog-QoL and Cog-Oth ranges between 0 and 16. The total score for the FACT-Cog is computed by summing all the item scores and ranges from 0 to 148 points, with a higher score indicative of better perceived cognitive functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perception of disease control</measure>
      <time_frame>Through study completion: an average of 1 year</time_frame>
      <description>Perceived Personal Control (PPC) scale: a 4-questions-scale, with each question evaluating in a 0-4 scale the perception of disease control (0: worse control to 4: best control)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Economic evaluation</measure>
      <time_frame>Through study completion: an average of 1 year</time_frame>
      <description>Questionnaire on the measurement, valuation, and estimation of costs adapted from a validated questionnaire on informal care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Through study completion: an average of 1 year</time_frame>
      <description>A checklist with acupuncture adverse events based on the Acupuncture-Adverse Events (AcupAE) questionnaire will be used to evaluate acupuncture-associated safety events after each treatment. For non-acupuncture complementary medicine therapies, the practitioner will directly question and evaluate the patient after each intervention for possible safety events. Specifically for dietary and herbal supplements, adverse events and interactions will be evaluated at each visit, and the Naranjo and adapted Drug Interaction Probability Scales (DIPS) will be used to assess the causality of such events with the specific dietary supplements.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relapse of lymphoma</measure>
      <time_frame>3 years</time_frame>
      <description>Based on clinical evaluation of the physician</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>3 years</time_frame>
      <description>Time from screening to the occurrence of disease progression or death, based on clinical evaluation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>3 years</time_frame>
      <description>Time from screening to death, based on clinical evaluation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Lymphoma</condition>
    <arm_group>
      <arm_group_label>Integrative oncology</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients will be followed up by a haemato-oncologist. The frequency and type of visits and exams will be determined by National Comprehensive Cancer Network (NCCN) guidelines, patients' symptoms and physician's clinical judgement. Patients recruited to the intervention arm will receive, on top of the defined conventional medicine follow-up, integrative oncology intervention including emotional treatments (counseling, spiritual guidance), complementary medicine (acupuncture, herbal supplements, mind-body, touch and/or movement therapies) or both. The type and frequency of these interventions will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional medicine only</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>All patients will be followed up by a haemato-oncologist. The frequency and type of visits and exams will be determined by NCCN guidelines, patients' symptoms and physician's clinical judgement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Acupuncture</intervention_name>
      <description>The frequency of acupuncture will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.</description>
      <arm_group_label>Integrative oncology</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Mind-body therapy</intervention_name>
      <description>The frequency of mind-body therapy (hypnosis, guided imagery) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.</description>
      <arm_group_label>Integrative oncology</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Touch therapy</intervention_name>
      <description>The frequency of touch therapy (shiatsu, reflexology) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.</description>
      <arm_group_label>Integrative oncology</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Movement therapy</intervention_name>
      <description>The frequency of movement therapy (Tai-Chi, Qi-Qong) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.</description>
      <arm_group_label>Integrative oncology</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Herbal supplements</intervention_name>
      <description>The choice of herbal supplement will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.</description>
      <arm_group_label>Integrative oncology</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Emotional treatment</intervention_name>
      <description>The frequency of emotional treatments (counseling, spiritual guidance) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.</description>
      <arm_group_label>Integrative oncology</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with a lymphoproliferative disease&#xD;
  &#xD;
            -  Aged 18 years or older&#xD;
  &#xD;
            -  Received chemotherapy, biological treatment or both for treating the&#xD;
               lymphoproliferative disease&#xD;
  &#xD;
            -  Defined in remission for less than one year by the haemato-oncologist (maintenance&#xD;
               therapy is authorized)&#xD;
  &#xD;
            -  Can respond to questionnaires&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria: None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ilana Levy Yurkovski, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bnai Zion Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dana Weizer</last_name>
      <phone>972-543295952</phone>
      <email>dana.weizer@b-zion.org.il</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bnai Zion Medical Center</name>
        <address>
          <city>Haifa</city>
          <zip>3339419</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ilana Levy Yurkovski, MD</last_name>
        <phone>972-525086128</phone>
        <email>ilana.levy@b-zion.org.il</email>
      </contact>
      <investigator>
        <last_name>Ilana Levy Yurkovski, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ohad Cohen Naznin</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lymphoma survivors</keyword>
    <keyword>Integrative medicine</keyword>
    <keyword>Complementary medicine</keyword>
    <keyword>Quality of life</keyword>
    <keyword>Shiatsu</keyword>
    <keyword>Acupuncture</keyword>
    <keyword>Hematology</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT05982223/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05982223
  org study id: 0050-23-BNZ
  nct id: NCT05982223
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Lymphoma is a cancer of the lymph nodes. While some are "silent" and only require follow-up,
        in cases of aggressive lymphoma, treatment is necessary, and usually includes biological
        drugs, chemotherapy or both. These drugs often cause significant damage to quality-of-life
        and various symptoms that do not always go away. Although the treatments are often limited in
        time and with recovery rates over 60%, most patients are left with a significantly impaired
        quality-of-life and difficulty in returning to their previous life. Many studies, most of
        which were conducted in breast cancer survivors, show the place of complementary medicine in
        the recovery process, both in terms of symptom relief and in improving quality-of-life. Few
        studies have examined the place of complementary and integrative medicine in lymphoma
        survivors. The purpose of the present study is to examine the effect of integrative
        treatments (a combination of conventional and complementary medicine) on quality-of-life of
        lymphoma survivors, on specific symptoms caused by the disease and its treatment, on economic
        and social aspects, as well as on the course of the disease. At the hematological unit of
        Bnai Zion Medical Center, Haifa, Israel, patients with lymphoma who have received
        chemotherapy, biological treatment or both, and have been defined as recovering by the
        treating hematologist, will be offered a choice of different types of complementary medicine
        (acupuncture, herbal medicine, mind-body, movement and touch therapies), emotional treatment
        (conversations with social worker, spiritual guidance), or both, in addition to the medical
        and nursing care offered to all survivors. Patients who prefer not to come to the clinic for
        these treatments will be assigned to the control group and will fill out questionnaires only.
        The duration of the treatments will be six months and follow-up for another two years. The
        type of treatments the patient will receive will be chosen in coordination between the
        integrative team and the patient and according to the symptoms. An assessment will be made on
        the effect of these treatments on quality-of-life of lymphoma survivors (based on
        questionnaires), including physical, psycho-spiritual and economic aspects, as well as on the
        course of the disease.
  Background: Lymphoma is a malignant disease of the lymph nodes. While some of the lymphomas
        are indolent and require only follow-up, in cases of aggressive lymphoma or indolent lymphoma
        with a high burden of disease, treatment is necessary and usually includes biological drugs,
        chemotherapy or both. These drugs often cause significant damage to quality-of-life,
        including various symptoms such as fatigue, gastrointestinal symptoms, neuropathy, as well as
        psycho-emotional and financial damage surrounding the cessation of work during the
        treatments. Although the treatments are often limited in time and with recovery rates above
        60% in the case of aggressive lymphoma, most patients are left with a significant impairment
        in the quality-of-life and difficulty in returning to the life before the disease. Survivor
        clinics are usually located outside the oncology clinics and are designed to help cancer
        patients return to life after they have recovered from the disease. Many studies, mostly in
        breast cancer survivors, show the place of complementary medicine in the recovery process,
        both in terms of relieving symptoms and improving quality-of-life. Few studies have examined
        the place of complementary medicine in survivor clinics in haemato-oncological patients after
        intensive and time-limited treatments. In addition, integrative oncology that incorporates
        both conventional and complementary medicine, is a developing discipline that has been shown
        to be effective in the relief of many cancer-related symptoms such as chemotherapy-induced
        peripheral neuropathy, which is common in lymphoma survivors, and other outcomes such as
        quality-of-life, or even survival.
  
        Hypothesis: In the present study, we assumed that an integrative oncology approach was
        effective for improving different outcomes of lymphoma survivors including quality-of-life,
        specific symptoms caused by the disease and its treatment, economic and social aspects, as
        well as the course of the disease.
  
        Study plan: At the Hematology Unit at Bnai Zion Hospital, adult lymphoma survivors that
        received chemotherapy, biologic therapy or both during active lymphoma treatment, and are
        willing to participate in the study, will be recruited up to one year after remission. After
        completing questionnaires and an initial assessment by the integrative team, the patients
        will be divided by preference between the control group who will receive the mandatory basic
        treatment for follow-up after the disease (medical and nursing); and the intervention group
        who will come to the clinic and receive, in addition to the above, emotional treatments
        (counseling, spiritual guidance), complementary medicine (acupuncture, herbal supplements,
        mind-body, touch and/or movement therapies) or both. The type and frequency of complementary
        therapy will be chosen by the integrative team in coordination with the patient, based on
        patient's symptoms and preferences. The duration of the intervention will be 6 months from
        recruitment. During follow-up, the patients will fill-out a MYCAW questionnaire to assess
        symptoms in each treatment (or once a month in the control group) and a safety assessment
        will be performed using the validated Acupuncture-Adverse Events (Acup-AE) questionnaire for
        acupuncture or targeted questioning for other treatments. Also, the patients will fill-out
        quality-of-life questionnaires once a month and economic and cognitive evaluation
        questionnaires once every 3 months. The haemato-oncologist will complete an assessment of the
        disease state once every 3 months. In addition, 3 months after the end of the treatments, the
        patients will fill-out all the same questionnaires for follow-up. The haemato-oncologist will
        perform a medical follow-up on the condition of the disease once every 3 months for two years
        from the end of the treatments at the survivor clinic.
  
        The primary outcome is the effect of an integrative approach on quality-of-life of lymphoma
        survivors. Secondary outcomes include the effect of such approach on specific symptoms caused
        by the disease and its treatment, economic and social aspects, as well as on the course of
        the disease.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Preference-based comparative effectiveness clinical trial
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: No masking
  measure: Quality-of-life by EQ-5D scale
  time frame: Through study completion: an average of 1 year
  description: EQ-5D scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
  measure: Symptom relief
  time frame: Through study completion: an average of 1 year
  description: Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing
  measure: Cognitive functions
  time frame: Through study completion: an average of 1 year
  description: Functional Assessment of Cancer Therapy - cognitive (FACT-cog) questionnaire: evaluates perceived cognitive functioning and their impact on quality of life. This is a self-reported 37-item questionnaire that consists of four subscales: Perceived Cognitive Impairment (CogPCI) (20 items), Perceived Cognitive Ability (CogPCA) (9 items), Comments from Others on Cognitive Function (Cog-Oth) (4 items), and Impact on Quality of Life (Cog-QoL) (4 items). All items are rated for the previous week, including the day of administration, on a 5-point Likert scale ranging from 0 "Never" or "Not at all" to 4 "Several times a day" or "Very much". The total CogPCI subscale ranges from 0 to 72, the CogPCA ranges between 0 and 28, and each of the Cog-QoL and Cog-Oth ranges between 0 and 16. The total score for the FACT-Cog is computed by summing all the item scores and ranges from 0 to 148 points, with a higher score indicative of better perceived cognitive functioning.
  measure: Perception of disease control
  time frame: Through study completion: an average of 1 year
  description: Perceived Personal Control (PPC) scale: a 4-questions-scale, with each question evaluating in a 0-4 scale the perception of disease control (0: worse control to 4: best control)
  measure: Economic evaluation
  time frame: Through study completion: an average of 1 year
  description: Questionnaire on the measurement, valuation, and estimation of costs adapted from a validated questionnaire on informal care
  measure: Adverse events
  time frame: Through study completion: an average of 1 year
  description: A checklist with acupuncture adverse events based on the Acupuncture-Adverse Events (AcupAE) questionnaire will be used to evaluate acupuncture-associated safety events after each treatment. For non-acupuncture complementary medicine therapies, the practitioner will directly question and evaluate the patient after each intervention for possible safety events. Specifically for dietary and herbal supplements, adverse events and interactions will be evaluated at each visit, and the Naranjo and adapted Drug Interaction Probability Scales (DIPS) will be used to assess the causality of such events with the specific dietary supplements.
  measure: Relapse of lymphoma
  time frame: 3 years
  description: Based on clinical evaluation of the physician
  measure: Progression-free survival
  time frame: 3 years
  description: Time from screening to the occurrence of disease progression or death, based on clinical evaluation
  measure: Overall survival
  time frame: 3 years
  description: Time from screening to death, based on clinical evaluation
  arm group label: Integrative oncology
  arm group type: Experimental
  description: All patients will be followed up by a haemato-oncologist. The frequency and type of visits and exams will be determined by National Comprehensive Cancer Network (NCCN) guidelines, patients' symptoms and physician's clinical judgement. Patients recruited to the intervention arm will receive, on top of the defined conventional medicine follow-up, integrative oncology intervention including emotional treatments (counseling, spiritual guidance), complementary medicine (acupuncture, herbal supplements, mind-body, touch and/or movement therapies) or both. The type and frequency of these interventions will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
  arm group label: Conventional medicine only
  arm group type: No Intervention
  description: All patients will be followed up by a haemato-oncologist. The frequency and type of visits and exams will be determined by NCCN guidelines, patients' symptoms and physician's clinical judgement.
  intervention type: Procedure
  intervention name: Acupuncture
  description: The frequency of acupuncture will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
  arm group label: Integrative oncology
  intervention type: Procedure
  intervention name: Mind-body therapy
  description: The frequency of mind-body therapy (hypnosis, guided imagery) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
  arm group label: Integrative oncology
  intervention type: Procedure
  intervention name: Touch therapy
  description: The frequency of touch therapy (shiatsu, reflexology) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
  arm group label: Integrative oncology
  intervention type: Procedure
  intervention name: Movement therapy
  description: The frequency of movement therapy (Tai-Chi, Qi-Qong) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
  arm group label: Integrative oncology
  intervention type: Dietary Supplement
  intervention name: Herbal supplements
  description: The choice of herbal supplement will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
  arm group label: Integrative oncology
  intervention type: Behavioral
  intervention name: Emotional treatment
  description: The frequency of emotional treatments (counseling, spiritual guidance) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
  arm group label: Integrative oncology
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ilana Levy Yurkovski, MD
  role: Principal Investigator
  affiliation: Bnai Zion Medical Center
  last name: Dana Weizer
  phone: 972-543295952
  email: dana.weizer@b-zion.org.il
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Lymphoma
  sharing ipd: No
  provided document: 