NCT03455023

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 30, 2018

Last Update Submit

January 13, 2019

Conditions

Cancer Pain

Keywords

Cancer painPharmaceutical care

Outcome Measures

Primary Outcomes (1)

  • Change in medication adherence

    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.

    Change from baseline at 1 month after discharge

Secondary Outcomes (4)

  • Change in pain score

    Change from baseline at 1 month after discharge

  • Change in quality of life

    Change from baseline at 1 month after discharge

  • Change in patients' knowledge of cancer pain and analgesics

    Change from baseline at 1 month after discharge

  • Incidence of adverse events [safety and tolerability]

    Up to 1 month after discharge

Study Arms (2)

pharmaceutical care intervention group

EXPERIMENTAL

Patients will receive individualized pharmaceutical care in addition to usual medical care.

Other: pharmaceutical care

control group

NO INTERVENTION

Patients will receive usual medical care.

Interventions

pharmaceutical careOTHER

Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.

pharmaceutical care intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

  • Zheng X, Ding H, Xu S, Xie R, Liu Y, Zhai Q, Fang L, Tong Y, Sun J, Xin W, Wu N, Chen J, Shi W, Yang L, Li H, Shao J, Wang Y, Yu H, Zhang B, Du Q, Yang Y, Zhang X, Duan C, Zhao Q, Shi J, Huang J, Fan Q, Cheng H, Chen L, Kong S, Zhang H, Gong L, Zhang Y, Song Z, Yang Y, Zhou S, Huang C, Lin J, Wang C, Huang X, Wei Q, Sun Y, Huang P. Pharmacist-Led Management Improves Treatment Adherence and Quality of Life in Opioid-Tolerant Patients With Cancer Pain: A Randomized Controlled Trial. Pain Ther. 2022 Mar;11(1):241-252. doi: 10.1007/s40122-021-00342-0. Epub 2022 Jan 29.

    PMID: 35092599DERIVED

MeSH Terms

Conditions

Cancer Pain

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ping Huang, Doctor

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Huang, Doctor

CONTACT

+86-571-88122118huangping1841@zjcc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pharmacy

Study Record Dates

First Submitted

January 30, 2018

First Posted

March 6, 2018

Study Start

June 30, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

CN(1)