Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590766
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Impact of Acupuncture and Manual Therapies on Patients Quality-of-life in a Hospital-to-community Continuum
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Acupuncture and Manual Therapies on Patients Quality-of-life in a Hospital-to-community Continuum of Integrative Oncology and Supportive-palliative Care
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 IOpalliative care specifying the patients 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 integrativepalliative 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 surgicalinternal 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 httpswwwrandomizerorg to one of the following study groups
Single-modality IO receiving acupressurerelaxation only Group A
Multi-modality IO receiving acupressurerelaxation 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 patients leading concern eg pain anxiety Following the QOL assessment in both groups an integrative or palliative intervention with the goal of alleviating the patients leading QoL-related concerns over the next 24-hour period
Patients in the IO intervention arm of the study will undergo acupressurerelaxation treatments only Single Modality Group A or with the addition of acupuncture Multi-Modality Group B The acupressureacupuncture 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 patients and their informal caregivers unmet needs and 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 surgicalinternal 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 httpswwwrandomizerorg to one of the following study groups
Single-modality IO receiving acupressurerelaxation only Group A
Multi-modality IO receiving acupressurerelaxation 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 patients leading concern eg pain anxiety Following the QOL assessment in both groups an integrative or palliative intervention with the goal of alleviating the patients leading QoL-related concerns over the next 24-hour period
Patients in the IO intervention arm of the study will undergo acupressurerelaxation treatments only Single Modality Group A or with the addition of acupuncture Multi-Modality Group B The acupressureacupuncture 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 patients and their informal caregivers unmet needs and QoL-related concerns
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None