A Psycho-educational Intervention for Symptom Cluster Management

Study Overview
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Brief Summary
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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.

Official Title
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A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam

Conditions
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Cancer, Oncology

Intervention / Treatment
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* Other: Psycho-educational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in the control group received standard treatment from oncologists and nurses at Hanoi Medical University Hospital. | |
| Experimental: Intervention<br>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. | Other: Psycho-educational intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, symptom cluster, oncology, psychoeducation, symptom management, fatigue, sleep disturbance