A Psycho-educational Intervention for Symptom Cluster Management

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332199
• Other study ID #: 1600000809
• Status: Completed
• Phase: N/A
• First received: October 30, 2017
• Last updated: November 1, 2017
• Start date: September 1, 2016
• Est. completion date: October 20, 2017

Study information

• Verified date: November 2017
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 20, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Oncology
• Syndrome

Intervention

Other:
• Psycho-educational intervention
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.

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Hanoi Medical University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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