A Study to Collect Data About Analgesia in Patients With Bone Metastasis

• Sponsor: Tools4Patient (Other)
• Overall Status: Completed
• CT.gov ID: NCT02774213
• Collaborator: (none)
• Enrollment: 74
• Locations: 8
• Duration (Months): 33.9
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.

Condition or Disease	Intervention/Treatment	Phase
Bone Metastasis	Other: Questionnaires completion; Other: Clinical Pain Assessments

Study Design

• Study Type: Observational
• Actual Enrollment: 74 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Apr 28, 2017
• Actual Study Completion Date: Apr 28, 2017

Outcome Measures

Primary Outcome Measures

1. Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS) [Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)]

   11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)

Secondary Outcome Measures

1. Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS) [Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)]

   11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was was the mean of the WPS of the first 7 days after first visit (Visit 1); end of study measure was the mean of the WPS of the last 7 days prior to last visit (Visit 2)

2. Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI) [Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)]

   The pain severity score of BPI is an arithmetic average of the 4 severity scores reported on an 11- point NRS going from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI severity questions are: 3. Your pain at its worst in the last 24 hours? 4. Your pain at its least in the last 24 hours? 5. Your pain on the average? 6. How much pain you have right now?

3. Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC) [Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)]

   Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst

4. Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC) [Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)]

   Patient subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst

5. Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs) [Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)]

   Number of symptoms measured after Clinical Pain Assessments (CPAs), 0 no symptom to 3 all the three symptoms : Hyperalgesia, Hypoesthesia, and Sensory loss.

6. Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30). [Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)]

   Pain scale of the Quality-of-Life Questionnaire in 30 questions (QLQ-C30); 2 items in the Pain scale ranging each from 1 to 4 (high score for a symptom scale / item represents a high level of symptomatology / problems); Pain score is sum of of the 2 items

7. Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI) [Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)]

   The pain interference score of BPI is an arithmetic average of the 7 interference scores reported on an 11-point NRS going from 0 (does not interfere) to 10 (completely interferes) The BPI interference questions are: 9. Pain has interfered in the last 24 hours with General Activity? Mood? Walking Abililty? Work? Relations with other people? Sleep? Enjoyment of life?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with bone tumors or bone metastasis from any primary cancer origin that is supported by histological or radiological investigations.

• Patients having been or being treated for their bone metastasis and/or their primary cancer.

• Patients who require analgesic treatment for unsatisfactory pain relief.

• Patients will be required to score at least 4 on the WAPS 11-point NRS during the week preceding enrollment.

• Patients undergoing or not a radiotherapy program provided visit procedures are performed before any radiotherapy sessions if scheduled on the same visit days.

• Are men or women of at least 18 years of age.

• Are reliable and willing to make themselves available for the entire duration of the study and are willing to follow study procedures.

• Have given written informed consent approved by the relevant Ethics Committee governing the study site.

Exclusion Criteria:

• Patients having had a major surgery within 28 days prior to signing Informed Consent Document or planning to have a major surgery during the study.

• Patients having a life expectancy < 3 months according to Investigator judgment.

• Patients having poor nutritional status or whose condition is unstable or who could be rapidly deteriorating in such a way that they would not be able to complete the study.

• Patients with a current or recent history unrelated to their cancer condition, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.

• Patients having a Karnofsky performance status below 70% or WHO score (Eastern Cooperative Oncology Group (ECOG)/Zubrod score) above 1.

• Are Investigator site staffs directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

• Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient.

• Patients under legal protection, according to the country law.

• Patients currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Bordet	Brussels		Belgium	1000
2	Cliniques Universitaires Saint Luc	Brussels		Belgium	1200
3	Universitair Ziekenhuis Antwerpen	Edegem		Belgium	2650
4	ATC, CHU Sart Tilman	Liège		Belgium	4000
5	Hôpital A. Mignot	Le Chesnay		France	78157
6	Centre Oscar Lambert	Lille		France	59000
7	Hôpital La Timone	Marseille		France	13385
8	Institut Curie	Paris		France	75005

Sponsors and Collaborators

• Tools4Patient

Investigators

• Study Director: Alvaro Pereira, Tools4Patient

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 10, 2017
• Study Protocol - Nov 24, 2014

More Information

Publications

None provided.

• Responsible Party: Tools4Patient
• ClinicalTrials.gov Identifier: NCT02774213
• Other Study ID Numbers: T2001-01
• First Posted: May 17, 2016
• Last Update Posted: Aug 19, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases

Study Results

Participant Flow

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Period Title: Overall Study
STARTED	74
COMPLETED	55
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Overall Participants	74
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	60.1
Sex: Female, Male (Count of Participants)
Female	42 56.8%
Male	11 14.9%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)
Description	11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)
Time Frame	Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)

Outcome Measure Data

Analysis Population Description

Only the patients completing the study per protocol were analyzed. APS was available for 47 patients amongst the per protocol completers.

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	47
Mean (Standard Deviation) [units on a scale]	2.26 (2.95)

2. Secondary Outcome

Title	Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)
Description	11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was was the mean of the WPS of the first 7 days after first visit (Visit 1); end of study measure was the mean of the WPS of the last 7 days prior to last visit (Visit 2)
Time Frame	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Outcome Measure Data

Analysis Population Description

Only the patients completing the study per protocol were analyzed. WPS was available for 46 patients amongst the per protocol completers.

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	46
Mean (Standard Deviation) [units on a scale]	1.23 (2.07)

3. Secondary Outcome

Title	Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)
Description	The pain severity score of BPI is an arithmetic average of the 4 severity scores reported on an 11- point NRS going from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI severity questions are: 3. Your pain at its worst in the last 24 hours? 4. Your pain at its least in the last 24 hours? 5. Your pain on the average? 6. How much pain you have right now?
Time Frame	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Outcome Measure Data

Analysis Population Description

Only the patients completing the study per protocol were analyzed. APS was available for 51 patients amongst the per protocol completers.

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	1.16 (2.11)

4. Secondary Outcome

Title	Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)
Description	Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Time Frame	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Outcome Measure Data

Analysis Population Description

Only the patients completing the study per protocol were analyzed. IGAC was available for 48 patients amongst the per protocol completers.

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	48
Mean (Standard Deviation) [units on a scale]	1.31 (2.42)

5. Secondary Outcome

Title	Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)
Description	Patient subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Time Frame	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Outcome Measure Data

Analysis Population Description

Only the patients completing the study per protocol were analyzed. PGAC was available for 50 patients amongst the per protocol completers.

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	50
Mean (Standard Deviation) [units on a scale]	1.22 (2.64)

6. Secondary Outcome

Title	Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)
Description	Number of symptoms measured after Clinical Pain Assessments (CPAs), 0 no symptom to 3 all the three symptoms : Hyperalgesia, Hypoesthesia, and Sensory loss.
Time Frame	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	67
Mean (Standard Deviation) [Number of symptoms]	0.34 (0.57)

7. Secondary Outcome

Title	Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).
Description	Pain scale of the Quality-of-Life Questionnaire in 30 questions (QLQ-C30); 2 items in the Pain scale ranging each from 1 to 4 (high score for a symptom scale / item represents a high level of symptomatology / problems); Pain score is sum of of the 2 items
Time Frame	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	-5.99 (13.81)

8. Secondary Outcome

Title	Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)
Description	The pain interference score of BPI is an arithmetic average of the 7 interference scores reported on an 11-point NRS going from 0 (does not interfere) to 10 (completely interferes) The BPI interference questions are: 9. Pain has interfered in the last 24 hours with General Activity? Mood? Walking Abililty? Work? Relations with other people? Sleep? Enjoyment of life?
Time Frame	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	Cancer patients with bone metastasis suffering from pain
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	1.42 (2.55)

Adverse Events

Time Frame	Not applicable: observational study (no safety measurements)
Adverse Event Reporting Description	Not applicable: observational study (no safety measurements)
Arm/Group Title	Cancer-Induced Bone Pain (CIBP)
Arm/Group Description	cancer patients with bone metastasis suffering from pain
All Cause Mortality
	Cancer-Induced Bone Pain (CIBP)
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Cancer-Induced Bone Pain (CIBP)
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Cancer-Induced Bone Pain (CIBP)
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.