A Psycho-educational Intervention for Symptom Cluster Management

NCT03332199 | Completed

• 1 other identifier: 1600000809
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Oncology

Keywords

symptom cluster; oncology; psychoeducation; symptom management; fatigue; pain; sleep disturbance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Performance status

  4 weeks

• Depression and Anxiety

  4 weeks

• Health-related quality of life

  4 weeks

Study Arms (2)

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.

Other: Psycho-educational intervention

Interventions

Psycho-educational intervention OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University

Hanoi, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 29505795 DERIVED

MeSH Terms

Conditions

Neoplasms; Syndrome; Fatigue; Pain; Parasomnias

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurologic Manifestations; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: September 1, 2016
• Primary Completion: February 28, 2017
• Study Completion: October 20, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)