Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Depression

Breast Neoplasms

Syndrome

Fatigue

Depressive Disorder

Receiving true somatic acupressure+usual care

Receiving sham somatic acupressure+usual care

Receiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice)

7-week self-acupressure plus usual care (an education booklet)

Somatic Acupressure

Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)

Sham acupressure

Usual care

Jing-Yu (Benjamin) Tan, PhD RN

Using a robust research method following the MRC Framework, the proposed study will develop and test an evidence-based complementary health intervention to help breast cancer patients manage the fatigue-sleep disturbance-depression symptom cluster.

The fatigue-sleep disturbance-depression (FSD) symptom cluster is one of the most common symptom clusters in breast cancer (BC) patients, which can significantly deteriorate patients' functional status and quality of life. Since symptom cluster management has been unsatisfactory by using pharmacological treatments alone, the use of non-pharmacological adjuvant approaches has therefore been recommended. Being an important modality of acupoint stimulation, somatic acupressure (SA) can be a promising non-pharmacological intervention given its potential benefits for cancer symptom alleviation and its convenience for self-practice without increasing patients' physical and financial burden. However, current research on acupoint stimulation for cancer symptom management has been mainly focusing on individual symptom, and intervention protocols have been found significantly varied in intervention dosages and acupoint formula without a standardised protocol developed via a rigorous evidence-based research approach. The proposed study therefore follows the Medical Research Council (MRC) Framework for Developing and Evaluating Complex Intervention (the MRC Framework) to develop an evidence-based SA protocol to help with a better management of the FSD symptom cluster in BC. The first two phases of the MRC Framework will be included in this study. The first phase utilizes an evidence-based method to comprehensively review all available research evidence on acupoint-stimulation for cancer-related fatigue, sleep disturbance and depression, and further identify the most effective acupoint formula with the optimal SA duration and frequency. A preliminary SA protocol will then be developed based on the current research evidence and relevant theories and guidelines of acupoint stimulation. A content validity study will be conducted then to examine the content validity of the SA protocol via an expert panel. In the second phase, a feasibility randomized controlled trial (RCT) will be conducted to examine the acceptability of the SA protocol, pilot the methodological procedure of the clinical trial and preliminarily examine the effects of SA on the FSD symptom cluster in BC. Semi-structured interviews will be conducted afterwards to explore patients' experiences of participating in the study and receiving the SA.

This study can perform a partial blind design for participants in the true and sham intervention groups. Blind of outcome assessment will be also achieved in the true and sham intervention groups as all the questionnaires are patient-reported and the participants themselves will be the outcome assessors. Data analysis will be conducted by an independent statistician who are blinded to the group allocation.

Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients

Development and Preliminary Evaluation of an Evidence-based Somatic Acupressure Protocol for the Self-management of Symptom Cluster of Fatigue, Insomnia and Depression in Breast Cancer Patients

Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100%

Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100%

Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100%

Attrition rate as assessed by (the number of participants who dropped out after the randomization / number of participants who enrolled in) x 100%

Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study

Time period from the recruitment of first participants to the last patient: assessed by months

The number of days that the participants perform the SA interventions, where the scheduled sessions should be 7 weeks of daily acupressure

Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes

Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews

Item-level missing value of each questionnaire (%) assessed by the percentage of participants who do not answer any single item

Scale-level missing value of the questionnaire (%) assessed by the percentage of participants who do not answer at least one item in the whole questionnaire

Number of adverse events occur during the intervention

Fatigue measured by the Multidimensional Fatigue Inventory

Insomnia measured by Pittsburgh Sleep Quality Index

Depression measured by Hospital Anxiety and Depression Scale

Measured by the Functional Assessment of Cancer Therapy-Breast Cancer

The Affiliated Hospital Of Southwest Medical University

Charles Darwin University

Nervous System Diseases

Dyssomnias

Parasomnias

Breast Diseases

Skin Diseases

standard care (intervention provided after the completion of the trial)

A booklet on the self-management of cancer symptoms. After the pilot RCT is completed, if the participants allocated to the control group are interested in practising tai chi, the intervention will be provided

control group

Around 60 minutes practising easy tai chi movements/postures twice per week

tai chi group

Jing-Yu (Benjamin) Tan, PhD

The Medical Research Council Framework for Developing and Evaluating Complex Interventions (MRC Framework) will be utilized to develop and evaluate an evidence-based tai chi intervention for managing the symptom cluster of fatigue-sleep disturbance-depression in breast cancer patients.

The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is regarded as one of the most common symptom clusters among breast cancer (BC) patients. Considering the fact that no specific medications can be recommended to relieve symptom clusters, numerous non-pharmacological interventions have therefore been performed with medication as a combination intervention for the treatment of symptom clusters in cancer patients. Among these interventions, tai chi could be an optimal option for relieving the FSDSC. The overall aims are to develop an evidence-based traditional Chinese exercise (TCE) tai chi protocol, test the feasibility of the protocol, and preliminarily examine the effectiveness of tai chi on the FSDSC and quality of life (QoL) through a pilot randomized controlled trial (RCT). The MRC Framework will be used to develop and evaluate an evidence-based intervention for BC patients. In phase one, an evidence-based TCE tai chi intervention protocol will be developed. An expert panel will then be invited to assess the content validity of the intervention protocol. Testing the feasibility of the tai chi intervention protocol, and preliminarily examining the effects of tai chi on the FSDSC will be conducted in phase two. After completion of the pilot RCT, semi-structured interviews will be conducted to assess the participants' experience of participating in the pilot trial and performing the tai chi exercise. The evidence-based tai chi intervention protocol for managing the FSDSC in breast cancer patients will be developed. The feasibility and effects of utilizing the tai chi intervention for BC patients will be explored. A future multicentre large-scale RCT to further evaluate the effects of tai chi on the FSDSC in the BC population will benefit from the study results of this doctoral research project.

Effects of a Traditional Chinese Exercise Program on Symptom Cluster in Breast Cancer Patients

Effects of a Traditional Chinese Exercise Program- Tai Chi on Symptom Cluster of Fatigue-sleep Disturbance-depression in Female Breast Cancer Patients: a Preliminary Randomized Controlled Trial

the time that was taken to recruit the planned sample size of participants

The number of referrals made by clinicians in different departments and hospitals divided by all referrals

The number of subjects who enrolled in the study divided by all subjects eligible for enrolment

The number of subjects who completed the study divided by all subjects who enrolled in the study

The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study

Feedback from the dropout subjects to identify their reasons for dropping out

The percentage of missing values for each item of the scales used, including the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-Breast (FACT-B)

The adherence rates will be measured by the number of tai chi sessions performed divided by the total possible tai chi sessions

Participants' feedback on and satisfaction with the intervention using a self-designed feedback form

In each tai chi session, the subjects in the intervention group will record whether they had any uncomfortable feelings

The participants in the tai chi group will be required to keep a diary to monitor their tai chi exercise after each tai chi session

Fatigue will be measured by the Brief Fatigue Inventory (BFI). The Brief Fatigue Inventory includes nine items using a 0- to 10-point Likert scale, where 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine" . The global BFI score, with a range between 0 and 90, is calculated as the mean of the nine items, and higher scores correspond to more severe fatigue

Sleep disturbance will be measured by the Pittsburgh Sleep Quality Index (PSQI). This 19-item questionnaire consists of seven components: subjective sleep quality (one item), sleep latency (two items), sleep duration (one item), habitual sleep efficiency (three items), sleep disturbance (nine items), use of sleeping medications (one item), and daytime dysfunction (two items). Each of the seven component scores are identified based on scoring algorithms, with each item using a 4-point Likert response scale, ranging from 0 to 3. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher score on the global (total) score indicates poorer sleep quality.

depression will be measured by the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, self-report scale that includes two subscales, namely, the Anxiety subscale (HADS-A) and the depression subscale (HADS-D), which has seven items per subscale. The scale uses a 4-point Likert scale, ranging from 0 to 3. The sum of the ratings of 14 items yields a total score; the sum of the ratings of seven items in each subscale yields separate scores for anxiety and depression. The score ranges between 0 and 42 for the total score and between 0 and 21 for each subscale. Higher scores indicate greater severity of anxiety and depression.

Quality of life assessment will be measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B). The FACT-B is subdivided into four primary QoL domains, namely, Physical Well-Being (seven items), Social Well-Being (seven items), Emotional Well-Being (six items), and Functional Well-Being (seven items), and contains additional concerns for Beast Cancer (10 items) . The FACT-B has a 5-point Likert-type response scale, ranging from 0 to 4, where 0 = "not at all" and 4 = "very much". A summing-up of each FACT-B subscale creates the FACT-B total score, ranging from 0 to 148. Moreover, a higher FACT-B score indicates a better QoL status.

The Affiliated Hospital of Putian University

Professor in Nursing

Nutritional and Metabolic Diseases

Neoplasm Metastasis

Dehydration

Water-Electrolyte Imbalance

Metabolic Diseases

Quality of Life

Culturally Tailored Nurse Symptom Management group (CTNSM) - participants in the CTNSM group will receive one in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message during the first 12 weeks of standard of care chemotherapy. In addition, participants can receive standard of care chemotherapy education.

Participants in the control group will only be receiving the standard of care chemotherapy education.

The Culturally Tailored Nurse-delivered telephone/text message symptom-management intervention (CTNSM) intervention is an in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message conducted for the first 12 weeks of standard of care chemotherapy .

CTNSM

Standard of Care chemotherapy education is a one-time patient education session about general treatment-related side effects patients can experience from chemotherapy and the interventions to mitigate the symptoms.

Standard of Care Chemotherapy Education

Natasha Solle, PhD

The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.

Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer

MD Anderson Symptom Inventory (MDASI) is a 19 item scale with a score range from 0-10 per symptom question that measures symptom severity plus symptom interference combined to measure total symptom burden. The higher score indicates worsening of symptoms.

Incidents of unscheduled medical visits for IV hydration

The CDSES is a 10 item scale with a score range from 0-10 per symptom question that measures perceived self-efficacy. The higher score indicates better perceived self-efficacy.

The PIHS is a 12 item scale with a score range from 0-8 per question that measures symptoms self-management. The higher score indicates better symptom self-management.

Feasibility will be reported as a percentage of completed calls or text messages.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Breast (FACT-B). FACT-B has a total scoring of 0-148 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Prostate (FACT-P). FACT-P has a total scoring of 0-156 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Colon (FACT-C). FACT-C has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Lung Cancer (FACT-LC). FACT-LC has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Oncology Nursing Society

University of Miami

assistant research professor

True self-acupressure plus routine methods of treatment and care.

Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care.

Participants will receive a 7-week true self-acupressure practice and a 12-week follow-up.

True acupressure

Participants will receive a 7-week sham self-acupressure practice and a 12-week follow-up.

Routine methods of treatment and care along with an updated education booklet.

Meng-Yuan Li, PhDc

Tao Wang, PhD

This study is designed following the updated Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions. The goal of this randomized controlled trial (RCT) is to evaluate the effects, safety, and cost-effectiveness of an evidence-based somatic acupressure (SA) intervention on the fatigue-sleep disturbance-depression symptom cluster and quality of life among breast cancer survivors.

Fatigue, sleep disturbance, and depression commonly co-occur in breast cancer (BC) survivors, forming a significant cluster known as the fatigue-sleep disturbance-depression symptom cluster (FSDSC). The FSDSC correlates notably with decreased everyday functioning and quality of life (QoL). Currently, there are no targeted pharmacological interventions available for alleviating the FSDSC in BC survivors. Additionally, concerns arise regarding the risks of drug-related adverse events and potential interactions with ongoing antineoplastic regimens when relying solely on pharmacological treatments. Consequently, nonpharmacological adjunct interventions have emerged as an alternative method. Somatic acupressure (SA) presents a promising nonpharmacological intervention for managing the FSDSC due to its advantages, including self-administration with minimal effort and time, lower cost, good tolerability, and minimal instruction required from clinical staff. However, the effectiveness of SA in improving the FSDSC in BC survivors remains uncertain. The proposed study follows the Medical Research Council (MRC) Framework for Developing and Evaluating Complex Intervention (the MRC Framework) to develop an evidence-based SA protocol to help with the better management of the FSDSC in BC survivors. The first phase identified and validated the most effective acupoint formula with the optimal SA duration and frequency based on multiple evidence bases. Subsequently, a well-designed phase II randomized controlled trial (RCT) was conducted. It demonstrated the feasibility of an evidence-based SA intervention protocol and its potentially positive effects on the FSDSC in BC survivors. The encouraging results, therefore, warrant further investigation through a large-scale RCT to ascertain the effects of SA on the FSDSC among BC survivors. The whole program is designed following the MRC Framework. Hence, the current study aims to evaluate the effects, safety, and cost-effectiveness of the SA protocol for managing the FSDSC in BC survivors through a phase III RCT.

This study can achieve a partial blind design for participants in the true and sham acupressure groups. Blind of outcome assessment will be also achieved in the true and sham intervention groups as all the questionnaires are patient-reported and the participants themselves will be the outcome assessors. Data analysis will be conducted by an independent statistician who are blinded to the group allocation.

Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial

The Brief Fatigue Inventory (BFI; 9 items) will be used to measure the participants' fatigue, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The global score for the BFI is calculated as the mean value of these 9 items. A higher score indicates greater severity of fatigue.

The Pittsburgh Sleep Quality Index (PSQI; 19 items) will be used to assess sleep disturbance. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher total score indicates poorer sleep quality.

The Hospital Anxiety and Depression Scale-Depression (HADS-D; 7 items; score range 0-21) will be used for evaluating depression. A higher score indicating greater severity of depression

The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess fatigue.

The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess sleep disturbance.

The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess depression.

The Functional Assessment of Cancer Therapy-Breast (FACT-B; 37 items) will be used for assessing the Patients' Quality of life. A summing-up of each FACT-B subscale creates the FACT-B total score, ranging from 0 to 148. A higher score indicates a better Quality of life.

Adverse events will be collected through regular contact between the participant and the research assistant across the intervention period.

A within-trial economic evaluation will be conducted whereby clinical outcomes (fatigue-sleep disturbance-depression symptom cluster and quality of life) and cost data will be compared between the true intervention group and the usual care group over 19 weeks. Data on economic-related resource use will be captured using a bespoke questionnaire over 19 weeks from randomization.

Second Affiliated Hospital of Zunyi Medical University

Zunyi Medical College

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

no Intervention

Yandi Zhu, Master's degree student

The goal of this observational study is to learn about in Patients treated with postoperative chemotherapy for ovarian tumors. The main questions it aims to answer are: • \[What symptom clusters are present in patients treated with postoperative chemotherapy for ovarian tumors\] • \[Are there differences in symptom clusters for patients with different TCM body types\] Participants will \[complete questionnaires prior to the start of chemotherapy and after the 1st, 3rd, and 6th chemotherapy treatments\].

Study on Symptom Clusters During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution

Correlation Study of Symptom Clusters and Negative Emotions During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution

Symptoms during chemotherapy,Examples include nausea, vomiting, hair loss, fatigue , etc.

The internal consistency, content validity, and validity of the scale were verified by combining the 13 core symptom items in the Chinese Version of the M.D. Anderson Symptom Inventory (MDASI-C) with the 9 ovarian cancer-specific symptoms. All entries (22) are numbered "0" to "10" to represent the degree of symptoms from "nonexistent" to "worst imaginable", and the symptoms assessed ranged from "nonexistent" to "worst imaginable". "The onset of the assessed symptoms was limited to the last 24 hours.

Yandi Zhu

Associate Chief Nurse

Pain

Participants in the control group received standard treatment from oncologists and nurses at Hanoi Medical University Hospital.

In addition to standard care provided by oncologists and nurses at Hanoi Medical University Hospital as described above, participants assigned to the intervention group received the psychoeducational intervention delivered by the nurse researcher.

The total program, consisting of three intervention sessions, was given over a period of 3 weeks. The one face-to-face session of an-hour's duration was provided within a week of the chemotherapy cycle following recruitment. Two booster sessions of 20-30 minutes were then conducted by phone at one-week intervals after the first intervention session.

Psycho-educational intervention

The purpose of this study is to develop, implement and undertake a preliminary evaluation of a psychoeducational intervention for managing a cancer-related symptom cluster including pain, fatigue and sleep disturbance experienced by Vietnamese cancer patients.

A Psycho-educational Intervention for Symptom Cluster Management

A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam

The three-single item Numeric Analogue Scales (fatigue, pain and sleep disturbance) were used at baseline and 4 weeks of the intervention to assess the change of symptom severity at cluster levels. The scales consists of a number of symptoms rated on the 11-point scales, with 0 referring to "not present" and 10 referring to "as bad as you can imagine". The symptom cluster severity was evaluated by averaging symptom summary scores, with a summary higher score indicating greater symptom cluster severity.

The Brief Fatigue Inventory (BFI) was used to assess the change of fatigue from baseline to 4 weeks of the intervention. The BFI consists of nine items assessing severity of fatigue in the past 24 hours (4 items) and its impacts on patients' different aspects of life, such as daily activity, emotional well-being, walking ability, work, and social interactions (5 items) on a 11-point scale. A summary higher score indicating greater fatigue severity and interference.

The Brief Pain Inventory was used to assess the change of pain from baseline to 4 weeks of the intervention. The Brief Pain Inventory - Short Form (BPI) encompasses a 4-item pain severity subscale and a 7-item pain interference with daily activities subscale. Each item was rated on 11-point numerical rating scales. A summary higher score indicating greater pain severity and interference.

The Pittsburgh Sleep Quality Index (PSQI) was used to assess patients' sleep quality and pattern at baseline and 4 weeks of the intervention. The scale consists of 19 self-reported items categorised in 7 domains, including sleep quality, duration, sleep effectiveness, sleep disturbances, sleep medication, and daytime dysfunction over the last month. Possible scores range from 0 to 21 with a higher score indicating greater sleep disturbance

Outcome measures included the Karnofsky Performance Scale at baseline and 4 weeks of the intervention. The scale ranges from 10 (moribund, fatal process progressing rapidly) to 100 (normal, no complaints, no evidence of disease).

The Hospital Anxiety and Depression Scale was used to assess the change of depression and anxiety at baseline and 4 weeks of the intervention. The Hospital Anxiety and Depression Scale includes 14 items separated into two subscales for anxiety (HADS-A: 7 items) and depression (HADS-D:7 items). For each sub-scale, the symptom is rated on a 22-point numerical scale which ranges from 0 (no symptom) to 21 (severe).

The EQ-5D-5L was used to evaluate health-related quality of life at baseline and 4 weeks of the intervention. The EQ-5D-5L includes five aspects: "mobility, self-care, usual activities, pain/discomfort and anxiety/depression". Each dimension has 5 levels: "no problem, slight problem, moderate problem, severe problem and extreme problem". Possible scores range from 0 to 5 with higher scores indicating poorer quality of five dimensions.

The EQ VAS records patient's general health-related quality of life on a visual analogue scale, with 0 being "worst imaginable health state" and 100 equal "best imaginable health state".

Hanoi Medical University

Principal Investigator

Anxiety Disorders

Sleep Initiation and Maintenance Disorders

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Sleep Disorders, Intrinsic

Sleep Wake Disorders

True self-acupressure group \[Enhanced standard care + True self-acupressure intervention protocol\]:

Participants in this group will practice the four-week acupressure protocol plus standard care. When participants admit hospital to receive chemotherapy treatment, they will receive a self-acupressure training section. Participants will be requested to practice acupressure at home once a day at night time (before going to bed) for four weeks. During the four weeks treatment, participants will receive a weekly phone call follow up from researchers.

Patients in this group will practice the four weeks sham self-acupressure protocol plus standard care. When participants admit hospital to receive chemotherapy treatment, they will receive a self-acupressure training section. Participants will be requested to practice sham acupressure at home once a day at night time (before going to bed) for four weeks. During the four weeks treatment, participants will receive a weekly follow up phone call from researchers

The standard care for cancer patients undergoing chemotherapy includes health assessment, regular health advice regarding symptoms that patients report and nutrition advice during taking chemotherapy treatment. Apart from the standard care, we provide participants a leaflet with 10 recommendations which help participants manage insomnia, depression, and anxiety. By providing this leaflet, we slightly enhance the standard care but do not contaminate the effective of the intervention since these tips are basic and participants can easily read about them on the internet or newspaper. In addition, to minimize the bias caused by contacting between interventionist and participants, we also provide participants in the enhanced standard care group weekly follow up phone call in four weeks.

We teach participants how to using self-acupressure to manage insomnia, depression, and anxiety. Six acupoints are included in our acupressure protocol which are Baihui, Yintang, Fengchi, Neiguan, Shenmen, and Taichong. Participants are requested to stimulate each acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from Anxiety and Depression Association of American.

Self-acupressure

We using a sham acupressure protocol to teach participants in this group. Six sham acupoints are included in the protocol. The sham acupoints are located 2-5cm away from the true acupoints. Participants are requested to stimulate each sham acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from the Anxiety and Depression Association of American.

Sham Self-acupressure

Huong TX Hoang, PhDc

Alex Molassitois, PhD

Tuyen T Nguyen, BSN

Anh H Vu, MPH

Quyen Ngo, MD

Van Tran, BSN

Anh H Nguyen, MPH

Huong TX Hoang

Alex Molassiotis

Aim: To assess the acceptability and make estimations about the effectiveness of using self-acupressure to manage insomnia, depression, and anxiety in cancer patients undergoing chemotherapy.

Study design: three-arms randomized sham-controlled trial. Participants will be assigned to the true self-acupressure group, sham acupressure group, or enhanced standard care group, with a ratio of 1:1:1 using block randomize.

Participants: patients receiving chemotherapy. 114 patients will be recruited to the study.

Inclusion criteria: Undergoing chemotherapy currently, Age 20 - 84 years' old, able to read and write Vietnamese, Karnofsky score ≥ 80, Insomnia Severity Index (ISI) score ≥ 11, Anxiety score measured by The Hospital Anxiety and Depression Scale (HADS) ≥ 8 and Depression score measured by HADS ≥ 8

Exclusion criteria:

Patients are excluded from the trial if they are unable to understand or cooperate with study procedures, receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at the same time as receiving chemotherapy and during the period of their involvement in the trial, participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception, having difficulties or are unable to practice self-acupressure by themselves, are receiving insomnia or depression/anxiety treatment currently.

Interventions Self-administered acupressure training section Participants in the true or sham self-acupressure groups will receive a self-administered acupressure training section based on their group assignment. Then, they will be requested to practice acupressure at home for 4 weeks.

Patient leaflet All of the participants in three groups will receive a patient leaflet with tips to manage insomnia, depression, and anxiety.

Weekly telephone reminder will be made to follow-up participants in all groups. Outcome measurement The recruitment rate, consent rate, refusal rate, attrition rate, adherence rate will be calculated. The acceptability of the intervention will be measured by the Intervention Rating Profile - 15. The ISI, The HADS, and The Functional Assessment of Cancer Therapy-General will be used to evaluate the effects of self-acupressure on the severity of insomnia, depression, anxiety. Others sleep parameters and adverse events associated with self-acupressure will be recorded.

1. Background Major treatments for cancer include surgery, radiotherapy, and chemotherapy improve patient's survival but also can exert a significant psychosocial and physical impact on patients by producing a variety of unpleasant symptoms. Applying the concept of identification symptom cluster by the correlation between symptoms, different sleep-related symptom clusters among cancer patient have been identified across studies such as: fatigue, depression and insomnia; pain, fatigue and or pain, depression, and insomnia. However, the correlation between insomnia and other symptoms was not fully explored. Therefore, to identify current evidence of sleep-related symptom cluster, we have conducted a cross-sectional survey among 213 cancer patients undergoing chemotherapy in Vietnam. The results indicated that among participants, a symptom cluster of insomnia, depression, and anxiety was evident.

   Based on the literature review, acupressure can potentially reduce insomnia as well as other symptoms in cancer patients. However, the use of acupressure in specific self-acupressure in managing symptom cluster of insomnia, depression, and anxiety is unknown but worthy for further research.
2. Methodologies of the study 2.1. The development of the self-acupressure protocols for managing insomnia, depression, and anxiety To distinguish the specific treatment (true) effects of acupressure treatment from the nonspecific treatment (placebo) effects, a true self-acupressure protocol and a sham self-acupressure protocol were being developed accordingly. The true acupressure protocol was developed based on the theory of Traditional Chinese Medicine (TCM), available systematic reviews are used for selecting acupoints and choosing treatment dose, and World Health Organization (WHO) standard acupuncture point location guidelines were used to locate the acupoint and technique for self-acupressure.

True and sham acupressure protocol These acupoints are being selected for the true acupressure protocol Baihui (GV20), Yintang (EX-HN3), Fengchi (GB20), Neiguan (PC6), Shenmen (HT7), Taichong (LR3) These points are being selected for the sham acupressure protocol SA 1: Base of metacarpal bone of the right middle finger SA 2 2 cm superior to the end of the right eyebrow SA 3 Mastoid bone SA 4 Head of ulnar styloid SA 5 Base of metacarpal bone of the index finger SA 6 Medial malleolus Duration of each section (true and sham acupressure): 24 minutes (3 mins per point) Duration of whole treatment (true and sham acupressure): 4 weeks (28 days) Time for practice self-acupressure: Before bedtime (final activities of the day, after practicing acupressure the participants should attempt to sleep) The suitability of true and sham self-acupressure protocols had been validated by a panel of six TCM experts from Hong Kong and Vietnam.

2.2. Methods of the feasibility study 2.2.1. The study design A feasibility study with three-arms randomized sham-controlled trial will be set up. The three arms are the true acupressure group, the sham acupressure group, and the enhanced standard care group.

2.2.2. Sample size Applying the rule of thumb, 30 subjects will be recruited for each study groups. The potential drop-out rate of 20% is used to calculate the total sample size for the feasibility study. Therefore, the sample size will be set at 114 patients with 38 patients per group.

2.2.3. Settings The study will be conducted in the Vietnam National Cancer Institute and Hanoi Oncology Hospital. All of them are located in Hanoi, the capital of Vietnam.

2.2.4. Randomization, allocation concealment, and blinding 2.2.4.1. Randomization and allocation concealment. Block randomization will be. 114 participants will be randomized into three study groups in a block of six participants. A randomization table will be computer generated by using the online randomizer. It will be prepared and kept by a researcher who does not involve in any research process. After recruiting enough participants for a block, the main researcher will send the list of participants' name to the randomization table keeper. The randomization table keeper will then randomly assign participants into trial groups based on the prepared randomization table and email the group assignments to the main researcher.

2.2.4.2. Blinding Participants randomized in the standard care group will know their group assignment, but participants randomize to the true and sham self-acupressure group will not know whether they receive true or sham self-acupressure treatment. Nevertheless, the outcomes of the study are all self-reported instruments, so the participants themselves could be viewed as "outcome assessors". Therefore, participants and "outcome assessors" located in the true or sham self-acupressure group will be blinded on the treatment allocation.

2.2.5. Study procedures Participants from five chemotherapy units will be recruited to the study (two chemotherapy units in hospital A, and three from hospital B). On the first day patients admitted to the hospital, during the health assessment, nurses will ask the patients to rate the severity of insomnia, depression and anxiety that they experience during the previous month. Each of the symptoms will be measured by separate Numerical Analog Scales (NAS). NAS is an 11-point scales with 0 means "not present" and 10 means "worst possible". If the patients rate 4 or above for their insomnia, depression, and anxiety nurses will inform the main researcher and introduce the potential patient to the main researcher. The main researcher will introduce the study in detail to potential participants and give them the information sheet and inform consent form. After signing the consent form, researchers will collect the demographic data of participants and instruct participants to complete the baseline assessment. After the participants complete the baseline assessment, the main researcher will summarize the result and if the participants eligible for the trial they will be instructed how to complete the seven days sleep diary after they discharge from the hospital. Afterward, participants will be randomly assigned to one of the following groups: the true self-acupressure group (TSA), the sham self-acupressure group (SSA) and enhanced standard care group (ESC).

Participants in the true self-acupressure group or sham self-acupressure group Participants in these group will either receive a true self-acupressure or sham acupressure training section based on their group assignment. Participants will be requested to practice acupressure at home for four weeks after they complete the sleep diary baseline assessment (a telephone reminder will be made). During the four weeks treatment, participants will receive a weekly phone call from researchers for encouraging to practice acupressure and answer inquiries may have. During this period, participant will be requested to complete Self-acupressure record form every day. After four weeks treatment, participants will be asked to complete and send back all the post-intervention assessing questionnaire to research by express service. A short-term follow up will be then carried out in four weeks to assess the persistence effect of acupressure on the symptoms outcome. During this time, the patient will not practice acupressure at home. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire to the main research by express service. 200,000 Vietnam dong (vnd) will be given to participants for the express service charge by the end of the follow-up time.

Participants in the enhanced standard control group Participants in the enhanced standard control group will receive the leaflet with tips to manage insomnia, depression, and anxiety. Weekly telephone reminder will also be made in four weeks. By the end of week fourth, participants in this group will be requested to complete post-intervention assessment and send back to research by post. A short-term follow up will be then carried out in 4 weeks. During the follow-up period, participants receive no weekly telephone reminder. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire to research by express service. 200,000 vnd will be given to participants for the express service charge by the end of the follow-up time.

2.2.5.1. Training of Subject recruitment Five nurses will be recruited for subject recruitment. Nurses who work in potential chemotherapy units with at least one year of experience in working with cancer patients will be recruited. They will receive a training section conducted by the main researcher on how to recruite participants.

2.2.5.2. Training of the interventionists Four nurses will be trained to become interventionists for the study (2 nurses/hospital). Nurses who work in potential hospitals with at least two years of experience in working with cancer patients will be recruited as interventionists of the study. A one hours training section (TOT section) will be delivered by the main researcher and a TCM professional.

2.2.5.3. Training of the participants in the true self-acupressure group and sham self-acupressure group: Participants locate in these groups will receive education section. The training will be conducted in a group of two to four participants in 45 minutes. The self-acupressure training section will take place in the consultation room in the chemotherapy unit. In the education section, interventionists will instruct the participants how to locate and stimulate acupoint following the acupressure protocols. After giving instruction and time for participants to practice, interventionists checksthe patient's mastery of self-acupressure technique by using the Acupressure Skill Check form for participants. If the participant fails to identify the acupoint or stimulate the acupoint wrongly, the interventionist will then correct them. By the end of the education section, a patient booklet includes step by step guideline with images-illustrating acupressure protocol will be given to participants.

2.3. Ethical consideration The study had gained ethical approval from The Hong Kong Polytechnic University and Vietnamese Ministry of Health. This study has followed the ethical principles for research that involves human subjects which are: autonomy, beneficence, non-maleficence, and confidentiality).

2.4. Data Analysis Data will be checked for normality, outliers, and missing data. Intention to treat principle is adapted for analyzing the result of the pilot study which use the "last value carried out forward" approach to replace missing data. Descriptive statistics will be used to analyze the sample characteristics, demographics, and data related to the intervention feasibility, acceptability and adverse event of acupressure. Baseline differences among the three groups will be compared by chi-square test and repeated measure ANOVA. In case the chi-square test is not appropriated because of low cell counts (≤ 5), it will be replaced by Fisher's exact test. The effect size will be calculated by Cohen d based on the mean difference between baseline and end of the treatment period for each symptom and the cluster of insomnia, depression, and anxiety in the true self-acupressure group and sham acupressure group. The significance level is set at 0.05. IBM SPSS 20.0 software will be used for data analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients	NCT04118140	Cancer	Somatic Acupres... Sham acupressur... Usual care	18 Years -	Charles Darwin University
Effects of a Traditional Chinese Exercise Program on Symptom Cluster in Breast Cancer Patients	NCT04190342	Breast Neoplasm... Symptom Cluster Tai ji	control group tai chi group	18 Years -	Charles Darwin University
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management	NCT04874584	Dehydration Symptom Cluster Quality of Life Self Efficacy Chemotherapy Ef...	CTNSM Standard of Car...	18 Years -	University of Miami
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients	NCT04118140	Cancer	Somatic Acupres... Sham acupressur... Usual care	18 Years -	Charles Darwin University
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors	NCT06412107	Breast Neoplasm... Symptom Cluster	True acupressur... Sham acupressur... Usual care	18 Years -	Charles Darwin University
Study on Symptom Clusters During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution	NCT06222008	Ovarian Cancer Radiotherapy Si... Symptom Cluster	no Intervention	18 Years -	Affiliated Hospital of Jiaxing University
Effects of a Traditional Chinese Exercise Program on Symptom Cluster in Breast Cancer Patients	NCT04190342	Breast Neoplasm... Symptom Cluster Tai ji	control group tai chi group	18 Years -	Charles Darwin University
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients	NCT04118140	Cancer	Somatic Acupres... Sham acupressur... Usual care	18 Years -	Charles Darwin University
A Psycho-educational Intervention for Symptom Cluster Management	NCT03332199	Cancer Oncology	Psycho-educatio...	18 Years -	Hanoi Medical University
Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety: a Feasibility Study	NCT03823456	Insomnia Anxiety Depression	Self-acupressur... Sham Self-acupr...	20 Years - 84 Years	The Hong Kong Polytechnic University

Spots Global Cancer Trial Database for symptom cluster