Clinical trial NCT03823456: Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety: a Feasibility Study
Official title: Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety in Cancer Patients: a Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Anxiety
Depression
Keywords: acupressure
insomnia
anxiety
depression
symptom cluster
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: True self-acupressure group \[Enhanced standard care + True self-acupressure\]:

Participants will practice the four-week acupressure protocol plus standard care. During the four weeks treatment, participants will receive a weekly phone call follow up from researchers.

Sham self-acupressure group \[Enhanced standard care + Sham self-acupressure\]:

Patients will practice the four weeks sham self-acupressure protocol plus standard care. During the four weeks treatment, participants will receive a weekly follow up phone call from researchers.

Enhanced standard care group The enhanced standard care in this study refers to standard care provided by the hospital includes health assessment, nutrition advice during taking chemotherapy treatment, hypnotics (Prescribe only where necessary by a doctor), and the enhanced care provided by the main researcher includes patient leaflet of tips on managing insomnia, depression, and anxiety; weekly follow-up phone call in four weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Undergoing chemotherapy currently.
* Able to read and write Vietnamese (to complete the questionnaires and provide informed consent).
* Have Karnofsky score ≥ 80 (to be able to practice self-acupressure).
* Have Insomnia Severity Index score ≥ 11
* Have Anxiety score measured by HADS ≥ 8 and Depression score measured by HADS ≥ 8

Exclusion Criteria:

* Are unable to understand or cooperate with study procedures.
* Are 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.
* Are participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception.
* Have difficulties or are unable to practice self-acupressure by themselves.
* Are receiving insomnia or depression/anxiety treatment currently.

Primary outcomes:
measure: Number of eligible participants
timeFrame: up to 15 weeks
measure: Number of patients who refuse to participant in the study
timeFrame: up to 15 weeks
measure: Acceptability score of the intervention measured by participants
timeFrame: One month after participants enroll the trial
measure: Acceptability of study procedures measured by participants
timeFrame: One month after participants enroll the trial
measure: Adverse events associated with self-acupressure reported by participants
timeFrame: One month after participants enroll the trial
measure: Change from baseline in insomnia score on Insomnia Severity Index at post intevention and after follow-up time
timeFrame: Change from baseline insomnia severity at one month and two months
measure: Change of participants' sleep parameter in sleep diary from baseline at post intervention and after follow-up time
timeFrame: Change from baseline at one month and two months
measure: Change from baseline in depression and anxiety scoreon Hospital Depression and Anxiety Scale at post intevention and after follow-up time
timeFrame: Change from baseline depression and anxiety severity at one month and two months
measure: Change from baseline in symptom cluster score on numerical analo scale from baseline at post intervetion and after follow-up time
timeFrame: Change from baseline symptom cluster severity at one month and two months
measure: Change in participants'quality of life on the Functional Assessment of Cancer Therapy-General scale from baseline at post intervention and after follow-up time
timeFrame: Change from baseline quality of life at one month and two months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Cancer Institution
state: Ha Dong
city: Hanoi
country: Vietnam
facility: Hanoi Oncology Hospital
state: Hai Ba Trung
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Huong TX Hoang
role: STUDY_DIRECTOR
affiliation: The Hong Kong Polytechnic University
name: Alex Molassiotis
role: PRINCIPAL_INVESTIGATOR
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