## Protocol Section
### Identification Module
**NCT ID:** NCT03205579

**Brief Title:** Pain Education to Improve Cancer Pain Management Patients

**Official Title:** Effectiveness of Pain Education to Improve Cancer Pain Management in Hospitalized Patients

#### Organization Study ID Info
**ID:** Si231/2017
#### Organization
**Class:** OTHER
**Full Name:** Mahidol University
### Status Module
#### Completion Date
**Date:** 2022-07-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-05

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2018-09-20

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2017-07-02
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-29
**Study First Submit QC Date:** 2017-06-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mahidol University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not affect only physical but also emotional and quality of life.

From review literatures we found that patients' knowledge about cancer pain management is inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer treatments, which can cause of unfavorable pain management outcome.

Therefore, we will conduct the RCT of using pain education by video comparing to conventional face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs examination for testing pre-post intervention to test level of understanding of patients. The measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that NRS should improve more than 50% at the seven day of study.

**Detailed Description:** protocol Randomized controlled trial study Sample size is 70 patients divided to 2 groups (35 for video group and 35 for conventional face to face group) Inclusion criteria

1. patients' age 18-70 years old
2. moderate to severe cancer pain
3. ECOG(Eastern cooperative Oncology Group) performance status \<= 3
4. Patients can write and read Thai language Exclusion criteria

1.Clinical unstability 2.Confusion and delirium 3.Bed ridden 4.Psychotic problem We will randomly allocate patients by using computer program nQuery advice 6.0. After patients sign inform consent we will record baseline characteristics, assess baseline Numerical rating scale (NRS), emotional status (ThaiHADs), Quality of life status (FACT-G). All patients will do the 25 MCQs test within 30 minutes before intervention. Video group will watch video 10 minutes and conventional group will receive pain education from trained nurse in the same period. The knowledge includes cancer pain definition, cancer pain management, pain assessment and role of patients in cancer pain management. After finishing intervention patients will the same 25 MCQs test (30 minutes) and patients can ask questions to the trained nurse.

All patients will be educated to record pain diary everyday for seven days. All patients will receive standard pain management from the physicians. At the day seven we will assess NRS, ThaiHADs and FACT-G and finish the study.

### Conditions Module

**Conditions:**

- Pain

- Inpatient

- Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Video cancer pain education (10 minutes ) the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.

**Intervention Names:**

- Other: Video group

**Label:** Video group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Face to face cancer pain education by trained nurse (10 minutes)the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.

**Intervention Names:**

- Other: conventional group

**Label:** Conventional group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Video group

**Description:** Using video for educate cancer pain patients

**Name:** Video group

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Conventional group

**Description:** Face to face cancer pain education by trained nurse

**Name:** conventional group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The pain reduction will be assessed and compared using numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between the first day and the seventh day of study

**Measure:** Pain intensity

**Time Frame:** seven days

#### Secondary Outcomes

**Description:** The emotional status of participants will be assessed and compared using Thai-HADs (Hospital Anxiety and Depression scale) between the first day and the seventh day of study. The score will be analyzed into depression and anxiety. the score 0-7 for either sub scale being in normal range, 8-10; being just suggestive of the presence of the respective state, a score of 11 or higher indicating probable presence of the mood disorder(Depression and Anxiety).

**Measure:** Emotional status

**Time Frame:** seven days

**Description:** Functional status will be assessed and compared using FACT-G between the first day and the seventh day of study. The subscale including physical well-being, social/family well-being, emotional well-being and functional well-being. Each items scored from 0-4; from 0 means "not at all" to 4 means "very much". The higher score would indicate better quality of life.

**Measure:** Functional assessment

**Time Frame:** seven days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* moderate to severe pain (NRS\>4) cancer pain
* ECOG (Eastern cooperative Oncology group) performance status \<=3
* Can read, listen, write Thai language

Exclusion Criteria:

* Clinical instability
* Confusion and delirium
* Bed ridden
* Psychotic problem

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bangkoknoi

**Country:** Thailand

**Facility:** Faculty of medicine Siriraj Hospital Mahidol University

**State:** Bangkok

**Zip:** 10700

**Location 2:**

**City:** Bangkok

**Country:** Thailand

**Facility:** Siriraj Hospital Mahidol University

**Zip:** 10700

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

**Name:** Suratsawadee Wangnamthip, md

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Wangnamthip S, Euasobhon P, Siriussawakul A, Jirachaipitak S, Laurujisawat J, Vimolwattanasarn K. Effective Pain Management for Inpatients at Siriraj Hospital: A Retrospective Study. J Med Assoc Thai. 2016 May;99(5):565-71.

**PMID:** 27501612

**Citation:** van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.

**PMID:** 17355955

**Citation:** Yates P, Dewar A, Edwards H, Fentiman B, Najman J, Nash R, Richardson V, Fraser J. The prevalence and perception of pain amongst hospital in-patients. J Clin Nurs. 1998 Nov;7(6):521-30. doi: 10.1046/j.1365-2702.1998.00192.x.

**PMID:** 10222947

**Citation:** Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998 Jul 8;280(2):147-51. doi: 10.1001/jama.280.2.147. Erratum In: JAMA 1998 Oct 7;280(13):1142.

**PMID:** 9669787

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M1091

- Name: Cancer Pain

- Relevance: HIGH

- As Found: Cancer Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000072716

- Term: Cancer Pain

### Misc Info Module

- Version Holder: 2024-05-24
