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

NCT ID: NCT06590766

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2027-06-30

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 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.

Conditions

Oncology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Integrative oncology single-modality

Acupressure/relaxation only

Group Type: EXPERIMENTAL

acupressure/relaxation with acupuncture

Intervention Type: OTHER

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.

Integrative oncology multi-modality

Acupressure/relaxation with acupuncture

Group Type: EXPERIMENTAL

acupressure/relaxation with acupuncture

Intervention Type: OTHER

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.

Palliative nursing counseling

Patients choosing to undergo a palliative nursing consultation only.

Group Type: ACTIVE_COMPARATOR

acupressure/relaxation with acupuncture

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Manual and mind-body therapies

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eran Ben-Arye

Director, Integrative Oncology Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Carmel Medical center

Haifa, Israel, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eran Ben-Arye, MD

Role: CONTACT

ERANBE@clalit.org.il

+97248568333

Facility Contacts

Eran Ben-Arye, MD

Role: primary

eranbe@clalit.org.il

972528709282 ext. 0

Eran Ben-Arye

Role: backup

References

Mao JJ, Ismaila N, Bao T, Barton D, Ben-Arye E, Garland EL, Greenlee H, Leblanc T, Lee RT, Lopez AM, Loprinzi C, Lyman GH, MacLeod J, Master VA, Ramchandran K, Wagner LI, Walker EM, Bruner DW, Witt CM, Bruera E. Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2022 Dec 1;40(34):3998-4024. doi: 10.1200/JCO.22.01357. Epub 2022 Sep 19.

Reference Type: BACKGROUND

PMID: 36122322 (View on PubMed)

Carlson LE, Ismaila N, Addington EL, Asher GN, Atreya C, Balneaves LG, Bradt J, Fuller-Shavel N, Goodman J, Hoffman CJ, Huston A, Mehta A, Paller CJ, Richardson K, Seely D, Siwik CJ, Temel JS, Rowland JH. Integrative Oncology Care of Symptoms of Anxiety and Depression in Adults With Cancer: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2023 Oct 1;41(28):4562-4591. doi: 10.1200/JCO.23.00857. Epub 2023 Aug 15.

Reference Type: BACKGROUND

PMID: 37582238 (View on PubMed)

Bower JE, Lacchetti C, Alici Y, Barton DL, Bruner D, Canin BE, Escalante CP, Ganz PA, Garland SN, Gupta S, Jim H, Ligibel JA, Loh KP, Peppone L, Tripathy D, Yennu S, Zick S, Mustian K. Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update. J Clin Oncol. 2024 Jul 10;42(20):2456-2487. doi: 10.1200/JCO.24.00541. Epub 2024 May 16.

Reference Type: BACKGROUND

PMID: 38754041 (View on PubMed)

Other Identifiers

CMC-23-0004

Identifier Type: -

Identifier Source: org_study_id