Integrative Medicine in Lymphoma Survivors
Effectiveness of Integrative Medicine Treatments in Lymphoma Survivors
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lymphoma
Started Jul 2023
Typical duration for not_applicable lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2023
CompletedFirst Submitted
Initial submission to the registry
July 16, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
August 8, 2023
July 1, 2023
5 years
July 16, 2023
July 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality-of-life by EQ-5D scale
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.
Through study completion: an average of 1 year
Secondary Outcomes (8)
Symptom relief
Through study completion: an average of 1 year
Cognitive functions
Through study completion: an average of 1 year
Perception of disease control
Through study completion: an average of 1 year
Economic evaluation
Through study completion: an average of 1 year
Adverse events
Through study completion: an average of 1 year
- +3 more secondary outcomes
Study Arms (2)
Integrative oncology
EXPERIMENTALAll 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.
Conventional medicine only
NO INTERVENTIONAll 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.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bnai Zion Medical Center
Haifa, 3339419, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilana Levy Yurkovski, MD
Bnai Zion Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2023
First Posted
August 8, 2023
Study Start
July 13, 2023
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
August 8, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share