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Individualized Pharmaceutical-care for Inpatients With Cancer Pain

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ClinicalTrials.gov Identifier: NCT03455023
Recruitment Status : Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
huangping, Zhejiang Cancer Hospital

Brief Summary:
The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients

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 inpatients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 Inpatients
Estimated Study Start Date : March 31, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

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.



Primary Outcome Measures :
  1. Change in medication adherence [ Time Frame: Change from baseline at 1 month after discharge ]
    The investigators will measure the change in medication adherence via Morisky Scale. 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 at 1 month after discharge ]
    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 at 1 month after discharge ]
    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 at 1 month after discharge ]
    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 after discharge ]
    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 of subjects who experienced an adverse event in this study is presented.



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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:

  • Current pregnancy or breastfeeding;
  • Patients diagnosed with non-cancer pain;
  • Patients treated with patient-controlled analgesia;
  • Patients with pathological fracture, gastrointestinal obstruction, severe infection, non-opioid related intractable constipation;
  • Patients with mental disorder;
  • Creatinine clearance rate <15mL/min;
  • ALT or AST ≥ 10 fold of upper limit of normal value

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455023


Contacts
Contact: Ping Huang, Doctor +86-571-88122118 huangping1841@zjcc.org.cn

Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Ping Huang, Doctor Zhejiang Cancer Hospital

Responsible Party: huangping, Chief of Pharmacy, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03455023     History of Changes
Other Study ID Numbers: ECCOPG-002
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018

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

Keywords provided by huangping, Zhejiang Cancer Hospital:
Cancer pain
Pharmaceutical care

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms