Integrative Medicine in Lymphoma Survivors

ConditionLymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBnai Zion Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Procedure/Surgery

    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.

  • Mind-body therapy

    Procedure/Surgery

    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.

  • Touch therapy

    Procedure/Surgery

    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.

  • Movement therapy

    Procedure/Surgery

    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.

  • Herbal supplements

    Dietary supplement

    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.

  • Emotional treatment

    Behavioral

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Integrative oncologyExperimental treatment 6 interventions
Group B: Conventional medicine onlyNo intervention 0 interventions

Trial outcomes

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.

Time frame
Through study completion: an average of 1 year

Secondary outcomes

1

Symptom relief

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

Time frame
Through study completion: an average of 1 year
2

Cognitive functions

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.

Time frame
Through study completion: an average of 1 year
3

Perception of disease control

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)

Time frame
Through study completion: an average of 1 year
4

Economic evaluation

Questionnaire on the measurement, valuation, and estimation of costs adapted from a validated questionnaire on informal care

Time frame
Through study completion: an average of 1 year

Other outcomes

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