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Impact of Acupuncture and Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum

NCT06590766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

OTHER

acupressure/relaxation with acupuncture

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.

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2026-12-30
Completion
2027-06-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06590766 on ClinicalTrials.gov