Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Weight Loss

Malnutrition

Head and Neck Neoplasms

Body Weight

Body Weight Changes

Nutrition Disorders

Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C.

Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.

Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.

Nutritional therapy education and evaluation is assessed per the attending dietitian.

The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H\&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.

Head and Neck Cancer patients receiving Chemotherapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and C.

Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.

Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.

Nutritional therapy education and evaluation is assessed per the attending dietitian.

The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H\&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.

Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and B.

Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.

Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.

Nutritional therapy education and evaluation is assessed per the attending dietitian.

The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H\&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.

The research nurse will provide educational intervention at each study visit utilizing the nursing process.

Nursing Education related to Gastrostomy Tube Care

Speech therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Speech therapy and evaluation is assessed per the attending speech therapist. The study team will collect all data related to speech therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.

Speech Therapy Education and Evaluation

Nutritional therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Nutritional therapy and evaluation is assessed per the attending dietitian. The study team will collect all data related to nutritional therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.

Nutritional Therapy Education and Evaluation

30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.

Quality of Life Questionnaire C30 version 3

35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.

Quality of Life Questionnaire EORTC QLO - H&N35

Candida Barlow, MSN RN

Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for head and neck cancer. Inadequate dietary intake is multi factorial, with patients experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related to Head and Neck cancer treatment.

The purpose of this study is to assess the quality of life and educational intervention outcomes of Head and Neck Cancer patients who have a gastrostomy tube placed per standard of care.

A high incident of Gastrostomy tube replacement occurs related to clogged, dislodged, and/or pulled out tubes. In addition, patients not eating or drinking after Gastrostomy tube placement, compounded by complications related to radiation treatment, results in decreased swallowing function. Inadequate swallow function, especially when combined with inadequate use of Gastrostomy tube, due to non-functional tube or insufficient patient knowledge in use of tube, results in poor nutritional status and excessive weight loss.

Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement

Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 and EORTC QLO - H\&N35 Questionnaires.

Measure functional status of speech therapy every 30 days

Nursing Education utilizing the Gastrostomy Tube education booklet will improve patient's knowledge and management of Gastrostomy Tube care

St. John Health System, Oklahoma

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Oncology patients with a pain rating of four or greater will receive APA treatment for patients' cancer-related pain. The ear points will be determined by the corresponding body points related to the patient's specific pain. Pain data will be tracked by electronic surveys and Electronic Health Records.

Light touch using vaccaria seeds on corresponding ear points related to patient's pain.

APA Treatment

Chao Hsing Yeh, PhD

The aims of this proposal are to (1) examine the feasibility of providing a training course of Auricular Point Acupressure (APA) for clinical oncology nurses who can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on cancer-related pain (CRP) under the usual conditions.

Cancer-related pain (CRP) is considered one of the most challenging symptoms that cancer patients experience. Opioid use is the most common strategy to manage pain. However, pharmacological treatments are associated with a variety of adverse side effects, including drowsiness, constipation, dry mouth, and the potential for addiction. As a result, up to 52% of cancer patients do not receive adequate analgesic medication. The high prevalence of pain and ineffective CRP management highlight the limitations of current CRP strategies. An effective, nonpharmacological patient-managed strategy-that has potential to provide quick and low-cost pain relief without new side effects-is an essential next step to manage CRP.

Auricular point acupressure (APA), a non-invasive and nonpharmacological patient-managed strategy, can be an innovative solution for CRP. APA is derived from Chinese Medicine and is different from auricular acupuncture, which is an invasive (using needles) and passive treatment (administered by a licensed practitioner). APA is a non-invasive and active treatment for patients with pain and other symptoms. It involves needleless, acupuncture-like stimulation of ear points. Small seeds are taped on specific ear points for stimulation by patients. Once the seeds have been taped on the patient's ear by the skilled provider, the patient is able to co-manage patient's treatment at home. APA is popular in Taiwan, China, and Europe. Though its use is limited in the U.S., a limited number of clinical trials have supported APA. To achieve pain relief, the participant presses on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and also sustains pain relief for one month after a 4-week APA intervention. The rapid pain relief makes APA an attractive strategy to manage CRP.

The investigators' team has conducted a series of APA studies among patients with (1) chronic low back pain, (2) aromatase inhibitor musculoskeletal symptoms (AIMSS), (3) persistent post-mastectomy pain, and (4) chemotherapy-induced neuropathy (CIN). All of the investigators' pilot studies demonstrated better than a clinically significant pain reduction (30% reduction) after 4 weeks of APA and sustained effects for 1-month. Significant plasma inflammatory changes (IL-1β, IL-2, IL-6, Tumor Necrosis Factor α, and IFNγ) were found after 4 weeks, indicating that APA may affect brain macrophage-cells resulting in inflammatory cytokines alterations, leading to sustained pain relief at 1-month follow-up. Based on these findings, the investigators believe APA would be particularly suitable to reduce CRP. More importantly, easy implementation of APA and its immediate and lasting pain relief can empower and motivate cancer patients to adhere to APA treatment and allows patients to engage other forms of pain intervention, such as maintaining and/or increasing physical activity as a by-product of improved analgesia.

Nurses are the patient's first line of support in managing CRP; however, nurses have limited tools available to accomplish this. The most common treatments that nurses have at nurses' disposal are the usage of analgesics or referrals to specialty consultations. Once patients are referred, the role of nurses as cohesive guides and caretakers is often lost. To address this dilemma, patients and nurses need access to a therapy that can quickly relieve the pain, which, in turn, reduces the analgesic use and encourages patients and nurses to engage in other pain interventions. Due to the non-invasive characteristic of APA, nurses can learn APA and incorporate it into nurses' practice to provide pain relief and augment the effects of other pain interventions.

The aims of this proposal are to (1) examine the feasibility of providing a training course of APA for clinical oncology nurses which can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on CRP under the usual conditions.

Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain

Pain intensity in the last 24 hours (1) at its worst and (2) on average will both be measured on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).

Pain interference with general activity, mood, walking ability, normal work, relationships with other people, sleep and enjoyment of life will be measured on a scale of 0 (does not interfere) to 10 (completely interferes).

Dose of analgesic use will be collected in electronic health record (EHR) as part of routine nursing assessments for patient care.

Fatigue will be measured on a scale of 0 (energetic, no fatigue) to 10 (worst possible fatigue).

Sleep quality will be measured on a scale of 0 (very poor) to 10 (very good).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement	NCT02775721	Malnutrition Gastrostomy	Nursing Educati... Speech Therapy ... Nutritional The... Quality of Life... Quality of Life...	18 Years -	St. John Health System, Oklahoma
Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain	NCT04040140	Cancer-related ... Acupressure	APA Treatment	18 Years -	Johns Hopkins University
Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain	NCT04040140	Cancer-related ... Acupressure	APA Treatment	18 Years -	Johns Hopkins University
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement	NCT02775721	Malnutrition Gastrostomy	Nursing Educati... Speech Therapy ... Nutritional The... Quality of Life... Quality of Life...	18 Years -	St. John Health System, Oklahoma
Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain	NCT04040140	Cancer-related ... Acupressure	APA Treatment	18 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for nursing education