Back to resultsA Psycho-educational Intervention for Symptom Cluster Management
Primary Purpose
Cancer, Oncology
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Psycho-educational intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring symptom cluster, oncology, psychoeducation, symptom management, fatigue, pain, sleep disturbance
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hanoi Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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
Secondary Outcome Measures
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).
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).
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".
Full Information
NCT ID
NCT03332199
First Posted
October 30, 2017
Last Updated
November 1, 2017
Sponsor
Hanoi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03332199
Brief Title
A Psycho-educational Intervention for Symptom Cluster Management
Official Title
A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanoi Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Oncology
Keywords
symptom cluster, oncology, psychoeducation, symptom management, fatigue, pain, sleep disturbance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control group received standard treatment from oncologists and nurses at Hanoi Medical University Hospital.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Psycho-educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom cluster
Description
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.
Time Frame
4 weeks
Title
Fatigue
Description
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.
Time Frame
4 weeks
Title
Pain
Description
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.
Time Frame
4 weeks
Title
Sleep disturbance
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Performance status
Description
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).
Time Frame
4 weeks
Title
Depression and Anxiety
Description
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).
Time Frame
4 weeks
Title
Health-related quality of life
Description
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".
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Hanoi Medical University
City
Hanoi
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29505795
Citation
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.
Results Reference
derived
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A Psycho-educational Intervention for Symptom Cluster Management
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