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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Assessing patients' QoL-related concerns will be performed using the Edmonton Symptom Assessment Scale (ESAS) — Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
  Assessing the effectiveness and safety of an IO intervention involving acupressure and relaxation, either with or without the addition of acupuncture, on the severity of QoL-related concerns among hospitalized oncology patients. Of the three PROMs, ESAS asks respondents to score a list of 10 QoL-related concerns on a scale from 0 (no symptom) to 10 (worst severity of the symptom).
• Assessing patients' QoL-related concerns will be performed using the Measure Yourself Concerns and Wellbeing (MYCAW). — Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
  Of the three PROMs used to assess patients' QoL, in MYCAW, patients to list and then score (from 0 to 6; 6 is most severe) their 2 most severe QoL-related concerns.
• Assessing patients' QoL-related concerns will be performed using the European Organization for Research and Treatment of Cancer Quality of Life(EORTC QLQ-C30). — Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
  EORTC QLQ C-30 asks a number of QoL-related clusters of concerns, from 1 (not at all) to 4 (very much).
• Assessment of objective physiological changes during the intervention — During the 30 minutes intervention
  Assessment of objective physiological changes during the 30-minute intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout. At the same time, nociceptive levels (NOL) will be monitored using a PMD-200 device (Medasense, Ramat Gan, Israel).

Trial sites (1)

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