CancerNCT03332199
A Psycho-educational Intervention for Symptom Cluster Management
A study testing Psycho-educational intervention in people with Cancer and Oncology, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Psycho-educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2016to 20 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are diagnosed with any type of cancer
- Are over 18 years of age
- Have finished the second chemotherapy cycle
- Expected prognosis of at least 12 months
- Karnofsky level of ≥ 60/100.
- Report three symptoms: fatigue, pain and sleep disturbance at severity level of equal or above 3 during the past 7 days.
- Ability to communicate in Vietnamese
Who cannot join
- Inability to complete questionnaires or participate in the intervention due to literacy level or communication impairment.
- Have been diagnosed with major psychiatric morbidity such as suicidal tendencies or schizophrenia.
- Involved in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam
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.
- Being tested
- Psycho-educational intervention
- Keywords
- symptom cluster, oncology, psychoeducation, symptom management, fatigue, pain, sleep disturbance
- Medical subject headings
- Neoplasms, Syndrome, Fatigue, Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control group received standard treatment from oncologists and nurses at Hanoi Medical University Hospital. |
| Intervention | Experimental | 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. Receives: Other: Psycho-educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom cluster
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.
Measured: 4 weeks
Fatigue
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.
Measured: 4 weeks
Pain
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.
Measured: 4 weeks
Sleep disturbance
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
Measured: 4 weeks
Secondary outcomes (3)
Performance status
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).
Measured: 4 weeks
Depression and Anxiety
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).
Measured: 4 weeks
Health-related quality of life
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".
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Sep 2016
- Primary completion28 Feb 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ly Nguyen, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332199
- Sponsor's protocol ID
- 1600000809
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen LT, Alexander K, Yates P. Psychoeducational Intervention for Symptom Management of Fatigue, Pain, and Sleep Disturbance Cluster Among Cancer Patients: A Pilot Quasi-Experimental Study. J Pain Symptom Manage. 2018 Jun;55(6):1459-1472. doi: 10.1016/j.jpainsymman.2018.02.019. Epub 2018 Mar 2.
PubMed 29505795
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam
- ClinicalTrials.gov ID
- NCT03332199
- Acronym / sponsor ID
- 1600000809
- Keywords
- symptom cluster, oncology, psychoeducation, symptom management, fatigue, pain, sleep disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 6 Nov 2017 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group received standard treatment from oncologists and nurses at Hanoi Medical University Hospital. |
| Intervention | Experimental | Other: Psycho-educational interventionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are diagnosed with any type of cancer
- Are over 18 years of age
- Have finished the second chemotherapy cycle
- Expected prognosis of at least 12 months
- Karnofsky level of ≥ 60/100.
Key exclusion criteria (3 listed)
- Inability to complete questionnaires or participate in the intervention due to literacy level or communication impairment.
- Have been diagnosed with major psychiatric morbidity such as suicidal tendencies or schizophrenia.
- Involved in other clinical trials
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 |
|---|---|---|
| Psycho-educational interventionThe 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. | Other | Intervention |
Primary outcome
Symptom cluster
Time frame: 4 weeks
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.
Fatigue
Time frame: 4 weeks
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.
Pain
Time frame: 4 weeks
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.
Sleep disturbance
Time frame: 4 weeks
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
3 secondary outcomes
Performance status
Time frame: 4 weeks
Depression and Anxiety
Time frame: 4 weeks
Health-related quality of life
Time frame: 4 weeks
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 6 Nov 2017.
- Derived from this study: PubMed 29505795Nguyen LT, Alexander K, Yates P. Psychoeducational Intervention for Symptom Management of Fatigue, Pain, and Sleep Disturbance Cluster Among Cancer Patients: A Pilot Quasi-Experimental Study. J Pain Symptom Manage. 2018 Jun;55(6):1459-1472. doi: 10.1016/j.jpainsymman.2018.02.019. Epub 2018 Mar 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-educational intervention in people with Cancer and Oncology, run by Hanoi Medical University at 1 site in Vietnam.
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 7 inclusion and 3 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 6 Nov 2017. 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 Vietnam. 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?
Symptom cluster (time frame: 4 weeks). The study lists 4 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 NCT03332199, which also lists 1 linked publication.
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 6 Nov 2017.