Advanced CancerNCT03610243

Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients

A study testing Self-administered acupressure in people with Advanced Cancer and Acupressure, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

OBJECTIVE: To evaluate the effect of a patient-centered self-administered acupressure intervention on fatigue, sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, psychological distress, and health-related quality of life among Chinese advanced cancer patients. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Advanced Cancer, Acupressure
What is being tested?: Self-administered acupressure
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteHong Kong
Study dates: 7 Aug 2018to 31 May 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chinese ethnicity, 18 years of age or older, and ability to communicate in Cantonese or Putonghua;
Advanced-stage cancer diagnosis (i.e., colorectum- stage IV; lung - stage IIIB or IV non-small cell or extensive small cell; breast - stage IV; prostate- stage IV; liver - stage IV);
An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1; and
Experience of fatigue (rated ≥ 4 on the "fatigue worst" item of the BFI) AND sleep disturbance or pain, or both, in the past week (severity rated ≥ 3 on a 0-10 numeric rating scale)

Who cannot join

are receiving in-patient hospice care; or
are taking any medications for insomnia or depression; or
have psychiatric or serious medical disorders that may prevent them from comprehending or performing the intervention; or
received acupressure or acupuncture in the previous 3 months; or
are pregnant or lactating; or
have any injury or ulcers around the acupoints

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Queen Mary Hospital
Hong Kong, 000

Other trials in Hong Kong

About this study

Official title: Use of Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients: A Randomized Wait-list Controlled Trial

HYPOTHESIS TO BE TESTED: Upon intervention completion, the intervention group will exhibit lower levels of fatigue, pain, fatigue-sleep disturbance-pain symptom cluster severity, and psychological distress and higher levels of sleep quality and health-related quality of life than the wait-list control group.

DESIGN and SUBJECTS: A randomized wait-list controlled trial with intervention and wait-list control groups. A total of 30 Chinese advanced cancer patients who screen positive for moderate/severe fatigue with symptoms of insomnia and/or pain will be recruited.

STUDY INSTRUMENTS: Chinese versions of the Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy - General, and a demographic questionnaire.

INTERVENTION: A 4-week patient-centered self-administered acupressure intervention comprising 17.5 hours of individual training and self-practice.

MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, psychological distress, health-related quality of life, actigraphy.

DATA ANALYSIS: Linear mixed-effects models to assess between-group differences in outcome measures post-intervention and changes between data collection points, as well as whether the between-group differences vary across time.

EXPECTED RESULTS: The proposed patient-centered self-administered acupressure intervention is useful for alleviating the fatigue and related symptoms experienced by Chinese advanced cancer patients.

Read the detailed description

The prevalence and impacts of fatigue and related symptoms in cancer patients have been clearly demonstrated in the literature, which also emphasizes the need for evidence-based interventions targeting symptom management in such advanced patients. The main challenge is identifying an intervention that is not only effective in managing cancer-related symptoms but is also feasible, acceptable, and safe for this patient group. The proposed study aims to test the effects of a patient-centered self-administered acupressure intervention on fatigue management for Chinese advanced cancer patients using the robust study design of a randomized, wait-list controlled trial.

Conditions: Advanced Cancer, Acupressure
Being tested: Self-administered acupressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-administered acupressureBehavioural
Two 2-hour one-on-one training sessions in patient-centered self-administered acupressure will be provided by trainers in the first week (4 hours) in the patient's home or at the university, depending on his/her preference. From the second to fourth weeks of the intervention, participants will engage in 15 minutes of self-administered acupressure twice a day (for a total of 10.5 hours over the 3 weeks). They will log the frequency of self-practice in a diary and be encouraged to undertake self-practice beyond the 4-week intervention. At weeks 2, 3, and 4, a 1-hour follow-up visit will be conducted by the same team of trainers to reinforce learning and self-practice (for a total of 3 hours over the 3 weeks).

Study groups in NCT03610243
Study group	Role	What they receive
Self-administered acupressure	Experimental	The proposed self-administered acupressure intervention is patient-centered comprising four pre-selected acupoints that should be applied pressure on by all patients and a list of additional acupoints from which patients can choose two for self-administration according to the personalized recommendations of trainers. In this way, each patient will receive an individualized protocol (four pre-selected and two self-selected acupoints). The intervention consists of: individual participant training (Two 2-hour one-on-one training sessions in week 1), self-practice (15 minutes of self-administered acupressure twice a day), and follow-up visits (a 1-hour follow-up visit at weeks 2, 3, and 4). Receives: Behavioral: Self-administered acupressure
Wait-list control	No intervention	The wait-list control group will be contacted in the third week to attend a health talk unrelated to symptom management.

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Fatigue Inventory (BFI)
The questionnaire will be used for assessing levels of fatigue. The first three items (fatigue severity subscale) ask patients to describe their current fatigue, usual fatigue, and worst fatigue in the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life, with 0 = "does not interfere" and 10 = "completely interferes." The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
Measured: post-intervention (T1, 4 weeks later)
Brief Fatigue Inventory (BFI)
The questionnaire will be used for assessing levels of fatigue. The first three items (fatigue severity subscale) ask patients to describe their current fatigue, usual fatigue, and worst fatigue in the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life, with 0 = "does not interfere" and 10 = "completely interferes." The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
Measured: follow-up (T2, 8 weeks after T0)

Secondary outcomes (6)

Pittsburgh Sleep Quality Index (PSQI)
This 19-item questionnaire will be used to assess participants' sleep disturbance levels. The items form seven component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The scores for each component range from 0 to 3 and are summed to produce a global score ranging from 0 to 21, with higher scores denoting poorer sleep quality.
Measured: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Brief Pain Inventory (BPI)
The pain severity subscale (4 items) will be used to assess participants' pain intensity. The 4-item subscale assesses pain at its "worst," "least," "average," and "now" using an 11-point response format ranging from 0 ("no pain") to 10 ("pain as bad as you can imagine"). Average scores will be calculated and range from 0 to 10. The higher scores refer to higher pain intensity.
Measured: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Hospital Anxiety and Depression Scale (HADS)
This 14-item questionnaire will be used to measure the severity of participants' psychological distress. Responses are measured on a 4-point scale ranging from 0 ("not present") to 3 ("considerable"). The total score is the sum of the subscale scores (range: 0-42), with a higher score indicating more severe distress.
Measured: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Functional Assessment of Cancer Therapy - General (FACT-G)
The questionnaire consists of 27 items and will be used to assess health-related quality of life. Respondents have to rate each item with a score between 0 ("not at all") and 4 ("very much"). The subscale scores are added to obtain a total score (range=0-108), with a higher score representing a higher level of HRQOL.
Measured: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Symptom cluster severity
the average scores of the BFI and BPI severity subscales and the item on overall sleep quality in the PSQI (to be transformed to a 0-10 scale) will be used. The symptom cluster severity score will be calculated by averaging the fatigue, sleep disturbance, and pain summary scores. The average severity score range from 0 to 10, with higher scores representing higher severity.
Measured: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Actigraphy
Actigraphy will serve as an objective measure of activity levels (fatigue) and sleep quality. Patients will be asked to wear the device for three separate 72-hour periods.
Measured: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 201831 May 2019

First posted1 Aug 2018
Study start7 Aug 2018
Primary completion31 May 2019
Study completion31 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced CancerStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03610243
Sponsor's protocol ID: UW18381
Status last verified: Apr 2020
First submitted: 16 Jul 2018
Last updated: 3 Jun 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients: A Randomized Wait-list Controlled Trial
ClinicalTrials.gov ID: NCT03610243
Acronym / sponsor ID: UW18381
Conditions: Advanced Cancer, Acupressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Collaborators: Queen Mary Hospital, Hong Kong
Study start: 7 Aug 2018 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 31 May 2019 (actual)
First posted: 1 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

INTERVENTION: A 4-week patient-centered self-administered acupressure intervention comprising 17.5 hours of individual training and self-practice.

MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, psychological distress, health-related quality of life, actigraphy.

EXPECTED RESULTS: The proposed patient-centered self-administered acupressure intervention is useful for alleviating the fatigue and related symptoms experienced by Chinese advanced cancer patients.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Self-administered acupressure	Experimental	Behavioral: Self-administered acupressureThe proposed self-administered acupressure intervention is patient-centered comprising four pre-selected acupoints that should be applied pressure on by all patients and a list of additional acupoints from which patients can choose two for self-administration according to the personalized recommendations of trainers. In this way, each patient will receive an individualized protocol (four pre-selected and two self-selected acupoints). The intervention consists of: individual participant training (Two 2-hour one-on-one training sessions in week 1), self-practice (15 minutes of self-administered acupressure twice a day), and follow-up visits (a 1-hour follow-up visit at weeks 2, 3, and 4).
Wait-list control	No intervention	–The wait-list control group will be contacted in the third week to attend a health talk unrelated to symptom management.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Chinese ethnicity, 18 years of age or older, and ability to communicate in Cantonese or Putonghua;
Advanced-stage cancer diagnosis (i.e., colorectum- stage IV; lung - stage IIIB or IV non-small cell or extensive small cell; breast - stage IV; prostate- stage IV; liver - stage IV);
An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1; and
Experience of fatigue (rated ≥ 4 on the "fatigue worst" item of the BFI) AND sleep disturbance or pain, or both, in the past week (severity rated ≥ 3 on a 0-10 numeric rating scale)

Key exclusion criteria (6 listed)

are receiving in-patient hospice care; or
are taking any medications for insomnia or depression; or
have psychiatric or serious medical disorders that may prevent them from comprehending or performing the intervention; or
received acupressure or acupuncture in the previous 3 months; or
are pregnant or lactating; or

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Self-administered acupressureTwo 2-hour one-on-one training sessions in patient-centered self-administered acupressure will be provided by trainers in the first week (4 hours) in the patient's home or at the university, depending on his/her preference. From the second to fourth weeks of the intervention, participants will engage in 15 minutes of self-administered acupressure twice a day (for a total of 10.5 hours over the 3 weeks). They will log the frequency of self-practice in a diary and be encouraged to undertake self-practice beyond the 4-week intervention. At weeks 2, 3, and 4, a 1-hour follow-up visit will be conducted by the same team of trainers to reinforce learning and self-practice (for a total of 3 hours over the 3 weeks).	Behavioural	Self-administered acupressure

Primary outcome

Brief Fatigue Inventory (BFI)
Time frame: post-intervention (T1, 4 weeks later)
The questionnaire will be used for assessing levels of fatigue. The first three items (fatigue severity subscale) ask patients to describe their current fatigue, usual fatigue, and worst fatigue in the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life, with 0 = "does not interfere" and 10 = "completely interferes." The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
Brief Fatigue Inventory (BFI)
Time frame: follow-up (T2, 8 weeks after T0)
The questionnaire will be used for assessing levels of fatigue. The first three items (fatigue severity subscale) ask patients to describe their current fatigue, usual fatigue, and worst fatigue in the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life, with 0 = "does not interfere" and 10 = "completely interferes." The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).

6 secondary outcomes

Pittsburgh Sleep Quality Index (PSQI)
Time frame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Brief Pain Inventory (BPI)
Time frame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Hospital Anxiety and Depression Scale (HADS)
Time frame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Symptom cluster severity
Time frame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Actigraphy
Time frame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
Individual participant dataSharing planned: Undecided

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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shuk Ting Cheung, PhD principal investigator

The University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Self-administered acupressure in people with Advanced Cancer and Acupressure, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Fatigue Inventory (BFI) (time frame: post-intervention (T1, 4 weeks later)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03610243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.