Institute of Oncology, Shaare Zedek Medical Center
Jerusalem, 7791031, Israel
Location status: Recruiting
NCT Number: NCT04940780
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.).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Jerusalem, 7791031, Israel
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 are to include Reflexology, Shiatsu and Therapeutic Touch
Time frame: 8 weeks
Change from baseline to the end of the 8-week integrative treatment program
Time frame: 16 weeks
Change from baseline and 8-week assessment to 16 week follow-up
Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
Change in functional and symptom scores
Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
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
Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives
Time frame: At the end of the series of 8 weekly CIM treatment sessions (≤ 2 weeks after the last treatment session); after 16 weeks from baseline.
Any reported adverse events taking place during the study period which are considered to have possibly/probably resulted from the CIM intervention
Time frame: At 16 weeks from baseline.
Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation
Time frame: At baseline
Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).
Contact information is provided by the study sponsor or research team.
Shaare Zedek Medical Center
Other
Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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