Trial Title:
Integrative Medicine in Lymphoma Survivors
NCT ID:
NCT05982223
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
Lymphoma survivors
Integrative medicine
Complementary medicine
Quality of life
Shiatsu
Acupuncture
Hematology
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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
Intervention:
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
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bnai Zion Medical Center
Address:
City:
Haifa
Zip:
3339419
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Ilana Levy Yurkovski, MD
Phone:
972-525086128
Email:
ilana.levy@b-zion.org.il
Investigator:
Last name:
Ilana Levy Yurkovski, MD
Email:
Principal Investigator
Investigator:
Last name:
Ohad Cohen Naznin
Email:
Sub-Investigator
Start date:
July 13, 2023
Completion date:
July 2028
Lead sponsor:
Agency:
Bnai Zion Medical Center
Agency class:
Other
Source:
Bnai Zion Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05982223
