Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety: a Feasibility Study

NCT03823456 | Unknown

• 1 other identifier: HSEARS20180604004
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

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.

Conditions

Insomnia; Anxiety; Depression

Keywords

acupressure; insomnia; anxiety; depression; symptom cluster

Outcome Measures

Primary Outcomes (10)

• Number of eligible participants

  The recruitment rate is calculated by dividing the number of the eligible participant by the total number of screened participants

  up to 15 weeks

• Number of patients who refuse to participant in the study

  The refusal rate is calculated by dividing the number of participants who do not participate in the study by the total number of eligible participants

  up to 15 weeks

• Acceptability score of the intervention measured by participants

  The acceptability score of the intervention will be measured by The Intervention Rating Profile - 15 (Martens, Witt, Elliott, \& Darveaux, 1985). The Intervention Rating Profile - 15 (IRP-15) consists of 15 items; each item is rated on a six-point Likert scale ranging from one (Strongly disagree) to six (Strongly agree). The higher score indicated higher acceptability of the intervention. The scale had been validated, translated into Vietnamese with high reliability (Cronbach's α = 0.89) (Nguyen, Alexander, \& Yates, 2018)

  One month after participants enroll the trial

• Acceptability of study procedures measured by participants

  The attrition rate will be calculated by the number of participants who decide to discontinue the study and the number of participants who are lost to contact during the study period. Reason for dropping out and lost to contact will be recorded

  One month after participants enroll the trial

• Adverse events associated with self-acupressure reported by participants

  Participants will be requested to report potential adverse events related to acupressure in the "Self-Acupressure Record Form."

  One month after participants enroll the trial

• Change from baseline in insomnia score on Insomnia Severity Index at post intevention and after follow-up time

  The Insomnia Severity Index (ISI) is used to measure insomnia severity among participants. The ISI is a self-reported questionnaire consisting of seven items to assess the nature, severity, and impact of insomnia. A score of 7 items indicates the insomnia severity, the min score is 0 and the maximum score is 28, the higher score indicates worse insomnia severity. The insomnia severity is interpreted as follows: moderate insomnia (ISI score of 15 to 21), severe insomnia (ISI score of 22 to 28). This instrument had been validated translated into Vietnamese previously (Long, Thanasilp, \& Thato, 2016) and was being used in our previous study with high reliability (Cronbach's α = 0.92).

  Change from baseline insomnia severity at one month and two months

• Change of participants' sleep parameter in sleep diary from baseline at post intervention and after follow-up time

  A sleep diary is used to measure sleep parameters. The participant will be requested to complete a one-week sleep diary before starting practice acupressure, after the treatment period ends, and after. The sleep diary is used to measure these sleep parameters: Total Sleep time (minute), total time in bed (minute), the number of night awaken after sleep onset and sleep efficiency.

  Change from baseline at one month and two months

• Change from baseline in depression and anxiety scoreon Hospital Depression and Anxiety Scale at post intevention and after follow-up time

  The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith (1983) to measure depression and anxiety among participants. This scale has 14 items, seven items measuring anxiety and seven items measuring depression over the past week. The total depression/anxiety score range from 0 to 28 with the higher total score indicates worse depression/anxiety. This instrument had been translated into Vietnamese previously (Long et al., 2016) and was used in our previous study with the Cronbach's alpha for the scale was 0.87, and for anxiety, subscale was 0.86, and for depression, subscale was 0.76.

  Change from baseline depression and anxiety severity at one month and two months

• Change from baseline in symptom cluster score on numerical analo scale from baseline at post intervetion and after follow-up time

  Separate numerical analog scales (NAS) for each symptom will be used to measure the severity of the whole cluster in the previous month. The symptom severity score of each of symptom in the cluster will be measured by an 11-point scales with 0 means "not present" and 10 means "as bad as it could be." Symptom severity at the cluster level will be evaluated by the averaging symptom severity score of each symptom in the cluster.

  Change from baseline symptom cluster severity at one month and two months

• 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

  The Functional Assessment of Cancer Therapy-General (FACT-G) is used in this study to assess the quality of life in participants. The questionnaire consists of 27 items each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). This scale measures four sub-scales: Physical well-being (PWB, 7 items); Social/family well-being (SWB, 7 items); Emotional well-being (EWB, 6 items) and Functional well-being (FWB, 7 items). The total score range from 0 to 108, questions are phrased so that higher numbers indicate a better health state. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. This instrument has been translated into Vietnamese by the Functional Assessment of Chronic Illness Therapy system and had been used in the previous study with the Cronbach's alpha for the scale was 0.89, and for Emotional well-being, subscales were 0.78, FWB = 0.82, PWB = 0.81 and for SWB was 0.82.

  Change from baseline quality of life at one month and two months

Study Arms (3)

True self-acupressure group

EXPERIMENTAL

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.

Other: Self-acupressure

Sham self-acupressure group

PLACEBO COMPARATOR

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

Other: Sham Self-acupressure

Enhanced standard care group

NO INTERVENTION

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.

Interventions

Self-acupressure OTHER

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.

True self-acupressure group

Sham Self-acupressure OTHER

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 group

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

Vietnam National Cancer Institution

Hanoi, Ha Dong, 10000, Vietnam

RECRUITING

Hanoi Oncology Hospital

Hanoi, Hai Ba Trung, 10000, Vietnam

NOT YET RECRUITING

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression; Syndrome

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huong TX Hoang

  The Hong Kong Polytechnic University

  STUDY DIRECTOR

• Alex Molassiotis

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huong TX Hoang, PhDc

CONTACT

0988919709; xuan-huong.hoangthi@connect.poly.hk

Alex Molassitois, PhD

CONTACT

+8522766 6396; alex.molasiotis@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: In this study, due to the nature of the intervention, a partial double-blinded design will be employed. Participants randomize in standard care group will know their group assignment, but participants randomize to 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, therefore, to some extent, the participants themselves could be viewed as "outcome assessors". Therefore, participants and "outcome assessors" located in true or sham self-acupressure group will be blinded on the treatment allocation. To ensure the successful blinding design, healthcare provider working in the wards will not know the group allocation, the main researcher will also work with the head-nurse of the department to arrange patient in intervention group and control groups into different wards.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 30, 2019
• Study Start: December 4, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)