Trial Title:
Impact of Acupuncture and Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum
NCT ID:
NCT06590766
Condition:
Oncology
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Integrative oncology
Palliative care
Acupuncture
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
acupressure/relaxation with acupuncture
Description:
The acupressure/acupuncture points will be designated according to a protocol for each of
the four leading concerns (pain, fatigue, emotional, and gastrointestinal), based on
evidence-based research. For example, clinical guideline-based IO protocols for pain
relief will include the following analgesia-related acupressure/acupuncture points:
Liver-3, Taichong; Large-Intestine 4, Hegu; Stomach-36, Zusanli; Pericard-6, Neiguan;
Spleen-6, Sanyinjiao; Yin tang; as well as battlefield ear acupuncture points. In both IO
intervention groups, relaxation techniques will be tailored to the patient's main
concern, with the option of including breathing and guided imagery modalities as well.
Arm group label:
Integrative oncology multi-modality
Arm group label:
Integrative oncology single-modality
Arm group label:
Palliative nursing counseling
Other name:
Manual and mind-body therapies
Summary:
Oncology patients often suffer during hospitalization from pain, emotional distress,
gastrointestinal symptoms, weakness, and quality of life (QoL)-related concerns. A large
body of research has shown that acupuncture and other integrative oncology (IO)
modalities, when provided in conjunction with supportive care, can significantly address
and alleviate QoL-related concerns. In the proposed study, we examine an innovative model
of IO and palliative care, provided to patients with cancer during hospitalization.
Oncology patients at the Carmel Medical Center, Haifa, Israel, will be referred by
hospital to IO/palliative care, specifying the patient's QoL-related concerns. After
signing the informed consent form, patients will be asked to choose between IO
intervention (Group A and B) or palliative nursing counseling only (Group C). Patients
choosing to undergo integrative treatment will be randomly allocated to one of the two
study interventions: acupressure-relaxation alone (Group A); or acupressure-relaxation
modalities with acupuncture (Group B). The response to the study intervention for
QoL-related concerns will be re-assessed immediately; at 24-48 hours; and after 2 weeks
following the treatment. Patients will also undergo objective measurements during
treatment using Heart Rate Variability (HRV) and Nociception Levels (NOL) to determine
the impact of the intervention on their QoL and concerns. In summary, the proposed study
will examine the short-term impact of an integrative/palliative intervention on patient
QoL-related concerns, comparing acupressure-relaxation modalities with or without
acupuncture, as well as to patients receiving palliative nursing counseling. Following
discharge, treatments will be provided at one of six participating community IO services,
over a 12-week period, in coordination with the oncology and palliative care teams in the
community.
Detailed description:
Scientific background: The provision of complementary and integrative medicine therapies
within supportive and palliative oncology care (herewith, Integrative Oncology, IO) is
increasingly taking place in leading oncology centers across the globe. The Society for
Integrative Oncology (SIO) and the American Society of Clinical Oncology (ASCO) have
co-published clinical practice guidelines on the effective and safe use of these
modalities for patients with cancer. The proposed study will explore the provision of IO
care to patients with cancer during hospitalization, with the goal of addressing
emotional distress, pain, fatigue, gastro-intestinal symptoms, and other quality of life
(QoL)-related concerns.
Study objectives and purpose: The primary study objective is to improve patients'
QoL-related concerns while hospitalized for a variety of cancer-related indications.
This, in a clinical context in which in-patient IO interventions are provided together
with palliative care, with the two teams coordinating their work. Secondary objective is
to identify barriers and enablers to the continuity of IO care, following
hospitalization, for patients with cancer, from the in-patient hospital to the
out-patient community care setting.
Methods: Study design and setting: The proposed study will take place within a
prospective randomized controlled methodology, beginning with a patient-preference stage,
in which patients are asked to choose whether they are interested in undergoing IO
treatments or palliative nursing counseling.
Study population: Patients of either gender, diagnosed with cancer, age ≥ 18 years and
hospitalized in one of the five surgical/internal departments will be eligible for study
inclusion. Participating patients will be referred to the study team by a medical
healthcare provider in their respective departments, providing a list of clinical
indications for the referral.
Allocation to study arms and groups:
Participants will be allocated to one of the two primary study arms, based on their
preference for undergoing IO treatments:
- Integrative oncology (IO) arm (Groups A and B): Patients choosing to undergo IO
treatments, in addition to standard palliative care
- Palliative nursing counseling (Group C): Patients choosing to undergo a palliative
nursing consultation only.
Patients choosing to receive IO care will then be randomly and openly assigned to one of
the intervention groups, using the "Research Randomizer" online tool
(https://www.randomizer.org/), to one of the following study groups:
- Single-modality IO, receiving acupressure/relaxation only (Group A)
- Multi-modality IO receiving acupressure/relaxation with acupuncture (Group B) IO
treatments and palliative nursing consultation: Patients in the intervention arm of
the study (groups A and B) will be interviewed and assessed by the IO practitioner,
while a palliative nurse specialist will interview those choosing the palliative
nursing consultation (Group C). In all study groups, the interviews will address
QoL-related concerns, identifying the patient's leading concern (e.g., pain,
anxiety). Following the QOL assessment in both groups, an integrative or palliative
intervention with the goal of alleviating the patient's leading QoL-related concerns
over the next 24-hour period.
Patients in the IO intervention arm of the study will undergo acupressure/relaxation
treatments only (Single Modality, Group A), or with the addition of acupuncture
(Multi-Modality, Group B). The acupressure/acupuncture points will be designated
according to a protocol for each of the four leading concerns (pain, fatigue, emotional,
and gastrointestinal), based on evidence-based research. The palliative nursing
intervention (Group C) will entail a personalized bio-psycho-social-oriented discussion,
highlighting the patient's and their informal caregiver's unmet needs and QoL-related
concerns.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients diagnosed with cancer, age ≥ 18 years and hospitalized in one of the six
internal medicine and surgical departments in the hospital.
Exclusion Criteria:
Inability to read and provide informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Carmel Medical center
Address:
City:
Haifa
Zip:
35152
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Eran Ben-Arye, MD
Phone:
972528709282
Phone ext:
0
Email:
eranbe@clalit.org.il
Contact backup:
Last name:
Eran Ben-Arye
Start date:
April 18, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Carmel Medical Center
Agency class:
Other
Source:
Carmel Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06590766
