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

NCT06590766 | Recruiting DMC

• 1 other identifier: CMC-23-0004
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology

Keywords

Integrative oncology; Palliative care; Acupuncture

Outcome Measures

Primary Outcomes (4)

• Assessing patients' QoL-related concerns will be performed using the Edmonton Symptom Assessment Scale (ESAS)

  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).

  Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.

• Assessing patients' QoL-related concerns will be performed using the Measure Yourself Concerns and Wellbeing (MYCAW).

  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.

  Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.

• Assessing patients' QoL-related concerns will be performed using the European Organization for Research and Treatment of Cancer Quality of Life(EORTC QLQ-C30).

  EORTC QLQ C-30 asks a number of QoL-related clusters of concerns, from 1 (not at all) to 4 (very much).

  Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.

• Assessment of objective physiological changes during the 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).

  During the 30 minutes intervention

Secondary Outcomes (2)

• Identifying the most commonly reported QoL-related concerns of hospitalized oncology patients. This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.

  Before and immediately following the 30-minute intervention.

• Identifying barriers and enablers to the continuity of integrative oncology care.This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.

  Two weeks for patients with localized cancer; 12 weeks for patients with advanced cancer

Study Arms (3)

Integrative oncology single-modality

EXPERIMENTAL

Acupressure/relaxation only

Other: acupressure/relaxation with acupuncture

Integrative oncology multi-modality

EXPERIMENTAL

Acupressure/relaxation with acupuncture

Other: acupressure/relaxation with acupuncture

Palliative nursing counseling

ACTIVE COMPARATOR

Patients choosing to undergo a palliative nursing consultation only.

Other: acupressure/relaxation with acupuncture

Interventions

acupressure/relaxation with acupuncture 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.

Also known as: Manual and mind-body therapies

Integrative oncology multi-modality; Integrative oncology single-modality; Palliative nursing counseling

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with cancer, age ≥ 18 years and hospitalized in one of the six internal medicine and surgical departments in the hospital.

You may not qualify if:

• Inability to read and provide informed consent

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical center

Haifa, Israel, 35152, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 36122322 BACKGROUND

• 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.

  PMID: 37582238 BACKGROUND

• 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.

  PMID: 38754041 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Acupressure; Acupuncture Therapy; Mind-Body Therapies

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Eran Ben-Arye, MD

CONTACT

+97248568333; ERANBE@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Integrative Oncology Program

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 19, 2024
• Study Start: April 18, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)