Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05982223 |
| Other study ID # |
0050-23-BNZ |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 13, 2023 |
| Est. completion date |
July 2028 |
Study information
| Verified date |
July 2023 |
| Source |
Bnai Zion Medical Center |
| Contact |
Dana Weizer |
| Phone |
972-543295952 |
| Email |
dana.weizer[@]b-zion.org.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
