Integrative Oncology for Patient Symptoms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShaare Zedek Medical Center

About this trial

The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.

A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥ 18 years

undergoing active oncology treatment

fully understand the study plan

agree to sign the study informed consent form.

Disqualifiers

not fulfilling all of the study criteria

not interested in attending all 8 weekly CIM treatments sessions

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Other intervention

    Acupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms

  • Touch Therapies

    Other intervention

    Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Treatment groups

750 Participants
are divided into 4 treatment groups
Group A: Patient Preference Arm - AcupunctureActive comparator 2 interventions
Group B: Randomized Treatment Arm - AcupunctureActive comparator 1 intervention
Group C: Patient Preference Arm - Touch TherapyActive comparator 2 interventions
Group D: Randomized Treatment Arm - Touch TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

EORTC QLQ-C30 global health status / QoL scale

Change from baseline to the end of the 8-week integrative treatment program

Time frame
8 weeks

Secondary outcomes

1

EORTC QLQ-C30 global health status / QoL scale

Change from baseline and 8-week assessment to 16 week follow-up

Time frame
16 weeks
2

EORTC QLQ-C30 - additional outcomes

Change in functional and symptom scores

Time frame
From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
3

ESAS symptom severity scores

Change in severity scores for 10 quality-of life related items

Time frame
From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
4

MYCAW symptom severity scores

Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives

Time frame
From baseline to 8- (end of treatment program) and 16-week (post-program) assessment

Other outcomes

Sponsors and contacts

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