Individualized Pharmaceutical-care in Outpatients With Cancer Pain

• ClinicalTrials.gov Identifier: NCT03439904
• Recruitment Status: Unknown
• First Posted: February 20, 2018
• Last Update Posted: January 15, 2019
• Sponsor: Zhejiang Cancer Hospital
• Information provided by (Responsible Party): Ping Huang, Zhejiang Cancer Hospital

Study Description

Brief Summary:

The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients

Condition or disease	Intervention/treatment	Phase
Cancer Pain	Other: Pharmaceutical care	Not Applicable

Detailed Description:

This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients treated with sustained released morphine, oxycodone, and transdermal fentanyl.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients
• Actual Study Start Date: June 30, 2018
• Estimated Primary Completion Date: June 30, 2019
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: pharmaceutical care intervention group; Patients will receive individualized pharmaceutical care in addition to usual medical care	Other: Pharmaceutical care; Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
No Intervention: control group; Patients will receive usual medical care

Outcome Measures

Primary Outcome Measures :

1. Change in medication adherence [ Time Frame: Change from baseline at 1 month ]
   The investigators will measure the change in medication adherence via Morisky Scale from baseline to 1 months. Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.

Secondary Outcome Measures :

1. Change in pain score [ Time Frame: Change from baseline pain score at 1 month ]
   Comparison of pain score of cancer pain patients with or without pharmaceutical care. Pain score will be assessed using numeric rating scale (NRS). An NRS allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be."
2. Change in quality of life [ Time Frame: Change from baseline quality of life at 1 month ]
   Comparison of quality of life of cancer pain patients with or without pharmaceutical care. Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D). It is a questionnaire to measure quality of life. It contains 5 domains: Mobility; Self-care; Usual activity; Pain; Anxiety/depression. It also contains a visual analogue scale. Weights are used to score the responses to the 5 domains, with scores ranging from 0 to 1 (where a score of 1 represents a perfect state). For the visual analogue scale, participants draw a line from a box to the point on the thermometer-like scale corresponding to their health state, 0-100 (100 = Best health state)
3. Change in patients' knowledge of cancer pain and analgesics [ Time Frame: Change from baseline knowledge at 1 month ]
   Comparison of knowledge of cancer pain and analgesics for cancer pain patients with or without pharmaceutical care. Knowledge of pain treatment and analgesics will be assessed using investigator designed questionnaire. This questionnaire consists of 16 items assessing patients' knowledge about cancer pain, treatment of cancer pain and medications for cancer pain. The total score ranges from 0 to 16 with higher score indicating better knowledge.
4. Incidence of adverse events [safety and tolerability] [ Time Frame: Up to 1 month ]
   Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. Number and percentage of subjects who experienced an adverse event in this study is presented.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients aged 18 years or older;
• Histologically confirmed solid tumor;
• Diagnosed chronic cancer pain;
• Opioid-tolerant patients;
• Overall survival is expected to be over 3 months;
• Karnofsky performance score≥50;
• Willing and able to comply with the protocol

Exclusion Criteria:

• Patients aged 18 years or older;
• Histologically confirmed solid tumor;
• Diagnosed chronic cancer pain;
• Opioid-tolerant patients;
• Overall survival is expected to be over 3 months;
• Karnofsky performance score≥50;
• Willing and able to comply with the protocol

Contacts and Locations

Contacts

Contact: Ping Huang; +86-571-88122118; huangping1841@zjcc.org.cn

Locations

China, Zhejiang

Zhejiang Cancer Hospital; Recruiting

Hangzhou, Zhejiang, China, 310022

Contact: Ping Huang, Doctor

Sponsors and Collaborators

Zhejiang Cancer Hospital

More Information

• Responsible Party: Ping Huang, Chief of Pharmacy, Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03439904
• Other Study ID Numbers: ECCOPG-003
• First Posted: February 20, 2018
• Last Update Posted: January 15, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ping Huang, Zhejiang Cancer Hospital:

pharmaceutical care; adherence

Additional relevant MeSH terms:

Cancer Pain; Pain; Neurologic Manifestations