Integrative Medicine in Lymphoma Survivors
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ClinicalTrials.gov Identifier: NCT05982223 |
Recruitment Status :
Recruiting
First Posted : August 8, 2023
Last Update Posted : August 8, 2023
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Condition or disease | Intervention/treatment | Phase |
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Lymphoma | Procedure: Acupuncture Procedure: Mind-body therapy Procedure: Touch therapy Procedure: Movement therapy Dietary Supplement: Herbal supplements Behavioral: Emotional treatment | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Preference-based comparative effectiveness clinical trial |
Masking: | None (Open Label) |
Masking Description: | No masking |
Primary Purpose: | Supportive Care |
Official Title: | Effectiveness of Integrative Medicine Treatments in Lymphoma Survivors |
Actual Study Start Date : | July 13, 2023 |
Estimated Primary Completion Date : | July 2028 |
Estimated Study Completion Date : | July 2028 |
Arm | Intervention/treatment |
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Experimental: Integrative oncology
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.
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Procedure: Acupuncture
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. Procedure: Mind-body therapy 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. Procedure: Touch therapy 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. Procedure: Movement therapy 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. Dietary Supplement: Herbal supplements 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. Behavioral: Emotional treatment 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. |
No Intervention: Conventional medicine only
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.
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- Quality-of-life by EQ-5D scale [ Time Frame: Through study completion: an average of 1 year ]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.
- Symptom relief [ Time Frame: Through study completion: an average of 1 year ]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
- Cognitive functions [ Time Frame: Through study completion: an average of 1 year ]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.
- Perception of disease control [ Time Frame: Through study completion: an average of 1 year ]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)
- Economic evaluation [ Time Frame: Through study completion: an average of 1 year ]Questionnaire on the measurement, valuation, and estimation of costs adapted from a validated questionnaire on informal care
- Adverse events [ Time Frame: Through study completion: an average of 1 year ]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.
- Relapse of lymphoma [ Time Frame: 3 years ]Based on clinical evaluation of the physician
- Progression-free survival [ Time Frame: 3 years ]Time from screening to the occurrence of disease progression or death, based on clinical evaluation
- Overall survival [ Time Frame: 3 years ]Time from screening to death, based on clinical evaluation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients diagnosed with a lymphoproliferative disease
- Aged 18 years or older
- Received chemotherapy, biological treatment or both for treating the lymphoproliferative disease
- Defined in remission for less than one year by the haemato-oncologist (maintenance therapy is authorized)
- Can respond to questionnaires
- Signed informed consent
Exclusion Criteria: None
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): NCT05982223
Contact: Dana Weizer | 972-543295952 | dana.weizer@b-zion.org.il |
Israel | |
Bnai Zion Medical Center | Recruiting |
Haifa, Israel, 3339419 | |
Contact: Ilana Levy Yurkovski, MD 972-525086128 ilana.levy@b-zion.org.il | |
Principal Investigator: Ilana Levy Yurkovski, MD | |
Sub-Investigator: Ohad Cohen Naznin |
Principal Investigator: | Ilana Levy Yurkovski, MD | Bnai Zion Medical Center |
Documents provided by Bnai Zion Medical Center:
Responsible Party: | Bnai Zion Medical Center |
ClinicalTrials.gov Identifier: | NCT05982223 |
Other Study ID Numbers: |
0050-23-BNZ |
First Posted: | August 8, 2023 Key Record Dates |
Last Update Posted: | August 8, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma survivors Integrative medicine Complementary medicine Quality of life |
Shiatsu Acupuncture Hematology |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |