VINE: Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01752907
• Collaborator: (none)
• Enrollment: 304
• Locations: 51
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if patient education can affect patient reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: General Education DVD; Other: Bone Pain Education DVD	Phase 2

Detailed Description

In this study, the effect of patient education on reported bone pain in breast cancer patients receiving adjuvant or neoadjuvant chemotherapy and pegfilgrastim will be investigated.

Each patient will receive adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis, beginning in the first cycle and continuing throughout the study period. The study period for this study is the first 4 cycles of chemotherapy. participants can be planning to receive regimens with > 4 cycles, but data will only be collected for the first 4 cycles. The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician. Commercially available pegfilgrastim will be administered according to US Prescribing Information and is considered background therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: General Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Other: General Education DVD; A general chemotherapy side effects education DVD
Experimental: Bone Pain Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Other: Bone Pain Education DVD

Outcome Measures

Primary Outcome Measures

1. Maximum Patient-reported Bone Pain in Cycle 1 [Days 1 to 5 during cycle 1.]

   Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.

Secondary Outcome Measures

1. Maximum Patient-reported Bone Pain by Cycle and Across All Cycles [Days 1-5 for each treatment cycle]

   Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.

2. Mean Patient-reported Bone Pain by Cycle and Across All Cycles [Days 1-5 for 4 treatment cycles]

   Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.

3. Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles [Days 1-5 for 4 treatment cycles]

   Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.

4. Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting [From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks]

   Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.

5. Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting [From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.]

   Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.

6. Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles [From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.]

   Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Age 18 years or over

• Eastern cooperative oncology group (ECOG) performance status 0-2

• Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer

• Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy

• Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and pegfilgrastim as determined by the investigator

• Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the study period

• Has provided informed consent

• Able to understand the content of the DVD material, in investigator's opinion

• Able to read and understand English

Exclusion Criteria

• Planning to receive weekly chemotherapy

• Chronic use of oral non-steroidal anti-inflammatory drugs (NSAIDs) or oral antihistamines with the following exception:

• Chronic oral aspirin use for cardiovascular-related indications

• Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator

• Chronic oral steroid use. Premedication related to the administration of taxanes, and use of anti-emetics is allowed, per usual clinical practice.

• Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis

• Prior use of granulocyte-colony stimulating factor (G-CSF)

• Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony stimulating factor (GM-CSF) (sargramostim) use

• Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)

• Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer

• Currently enrolled in, or less than 30 days since ending, any pain intervention study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Fountain Valley	California	United States	92708
2	Research Site	Mission Hills	California	United States	91345
3	Research Site	Santa Rosa	California	United States	95403
4	Research Site	Vallejo	California	United States	94589
5	Research Site	Whittier	California	United States	90603
6	Research Site	Danbury	Connecticut	United States	06810
7	Research Site	Greenwich	Connecticut	United States	06830
8	Research Site	Fort Lauderdale	Florida	United States	33308
9	Research Site	Chicago	Illinois	United States	60616
10	Research Site	Elk Grove Village	Illinois	United States	60007
11	Research Site	Naperville	Illinois	United States	60540
12	Research Site	Peoria	Illinois	United States	61615
13	Research Site	Cedar Rapids	Iowa	United States	52403
14	Research Site	Mason City	Iowa	United States	50401
15	Research Site	Mt Sterling	Kentucky	United States	40353
16	Research Site	Lewiston	Maine	United States	04240
17	Research Site	Boston	Massachusetts	United States	02135
18	Research Site	Fairhaven	Massachusetts	United States	02719
19	Research Site	Lansing	Michigan	United States	48912
20	Research Site	Robbinsdale	Minnesota	United States	55422
21	Research Site	St. Louis Park	Minnesota	United States	55426
22	Research Site	Jefferson City	Missouri	United States	65109
23	Research Site	St. Louis	Missouri	United States	63136
24	Research Site	Omaha	Nebraska	United States	68106
25	Research Site	Portsmouth	New Hampshire	United States	03801
26	Research Site	Englewood	New Jersey	United States	07631
27	Research Site	Hamilton	New Jersey	United States	08650
28	Research Site	Morristown	New Jersey	United States	07960
29	Research Site	Vineland	New Jersey	United States	08360
30	Research Site	Albuquerque	New Mexico	United States	87109-4397
31	Research Site	Cooperstown	New York	United States	13326
32	Research Site	Glens Falls	New York	United States	12801
33	Research Site	Poughkeepsie	New York	United States	12601
34	Research Site	Suffern	New York	United States	10901
35	Research Site	Asheboro	North Carolina	United States	27203
36	Research Site	Charlotte	North Carolina	United States	28204
37	Research Site	Fayetteville	North Carolina	United States	28304
38	Research Site	Goldsboro	North Carolina	United States	27534
39	Research Site	Hendersonville	North Carolina	United States	28791
40	Research Site	Canton	Ohio	United States	44708
41	Research Site	Massillon	Ohio	United States	44646
42	Research Site	Middletown	Ohio	United States	45042
43	Research Site	Bend	Oregon	United States	97701
44	Research Site	Gettysburg	Pennsylvania	United States	17325
45	Research Site	Langhorne	Pennsylvania	United States	19047
46	Research Site	Aberdeen	South Dakota	United States	57401
47	Research Site	Sioux Falls	South Dakota	United States	57105
48	Research Site	Bristol	Tennessee	United States	37620
49	Research Site	El Paso	Texas	United States	79905
50	Research Site	Danville	Virginia	United States	24541
51	Research Site	Burien	Washington	United States	98166

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01752907
• Other Study ID Numbers: 20110148
• First Posted: Dec 19, 2012
• Last Update Posted: Jan 11, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Amgen: Breast cancer; Chemotherapy; Pegfilgrastim; Neulasta; Bone Pain; Education
• Additional relevant MeSH terms: Breast Neoplasms; Mastodynia

Study Results

Participant Flow

Recruitment Details	This study was conducted at 48 centers in the United States. Patients with stage I to III breast cancer planning to receive standard neoadjuvant or adjuvant chemotherapy regimens with pegfilgrastim support for at least 4 cycles were included. The first participant enrolled on 17 January 2013 and the last participant enrolled on 04 September 2014.
Pre-assignment Detail	Participants were randomized in a 1:1 ratio to receive 1 of 2 educational DVDs: general chemotherapy side effects education DVD (GE-DVD) or bone pain education DVD (BP-DVD). Participants remained on study for the first 4 chemotherapy cycles. End of study occurred 30 days after administration of pegfilgrastim in the fourth cycle of chemotherapy.

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Period Title: Overall Study
STARTED	151	153
Received Pegfilgrastim	149	151
COMPLETED	139	133
NOT COMPLETED	12	20

Baseline Characteristics

Arm/Group Title	General Education DVD	Bone Pain Education DVD	Total
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Total of all reporting groups
Overall Participants	149	151	300
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (10.4)	54.5 (10.4)	54.0 (10.4)
Sex: Female, Male (Count of Participants)
Female	149 100%	151 100%	300 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Asian	1 0.7%	5 3.3%	6 2%
Black (or African American)	19 12.8%	19 12.6%	38 12.7%
White	128 85.9%	124 82.1%	252 84%
Other	1 0.7%	3 2%	4 1.3%

Outcome Measures

1. Primary Outcome

Title	Maximum Patient-reported Bone Pain in Cycle 1
Description	Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
Time Frame	Days 1 to 5 during cycle 1.

Outcome Measure Data

Analysis Population Description

Full analysis set with imputation

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Measure Participants	149	151
Mean (Standard Error) [units on a scale]	3.2 (0.2)	3.5 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	General Education DVD, Bone Pain Education DVD
	Comments	There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3479
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -0.4 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	Treatment difference = bone pain DVD - general education DVD

2. Secondary Outcome

Title	Maximum Patient-reported Bone Pain by Cycle and Across All Cycles
Description	Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
Time Frame	Days 1-5 for each treatment cycle

Outcome Measure Data

Analysis Population Description

Full analysis set with imputation

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Measure Participants	149	151
Cycle 2 (n=145, 144)	2.5 (0.2)	2.7 (0.3)
Cycle 3 (n=142, 139)	2.7 (0.2)	2.6 (0.2)
Cycle 4 (n=141, 133)	2.4 (0.2)	2.5 (0.3)
All Cycles (n-149, 151)	4.1 (0.3)	4.6 (0.3)

3. Secondary Outcome

Title	Mean Patient-reported Bone Pain by Cycle and Across All Cycles
Description	Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
Time Frame	Days 1-5 for 4 treatment cycles

Outcome Measure Data

Analysis Population Description

Full analysis set with imputation

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Measure Participants	149	151
Cycle 1 (n=149, 151)	1.6 (0.2)	1.8 (0.2)
Cycle 2 (n=145, 144)	1.3 (0.1)	1.5 (0.2)
Cycle 3 (n=142, 139)	1.4 (0.2)	1.4 (0.2)
Cycle 4 (n=141, 133)	1.3 (0.1)	1.5 (0.2)
All cycles (n=149, 151)	1.5 (0.1)	1.6 (0.1)

4. Secondary Outcome

Title	Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles
Description	Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.
Time Frame	Days 1-5 for 4 treatment cycles

Outcome Measure Data

Analysis Population Description

Full analysis set with imputation

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Measure Participants	149	151
Cycle 1 (n=149, 151)	6.7 (0.6)	7.6 (0.7)
Cycle 2 (n=145, 144)	5.4 (0.6)	6.3 (0.7)
Cycle 3 (n=142, 139)	6.2 (0.6)	6.1 (0.7)
Cycle 4 (n=141, 133)	5.6 (0.6)	6.2 (0.7)
All Cycles (n=149, 151)	6.3 (0.6)	6.6 (0.6)

5. Secondary Outcome

Title	Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting
Description	Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.
Time Frame	From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Measure Participants	149	151
Cycle 1 (n=149, 151)	43.0 28.9%	40.4 26.8%
Cycle 2 (n=145, 144)	37.2 25%	35.4 23.4%
Cycle 3 (n=142, 139)	37.3 25%	35.3 23.4%
Cycle 4 (n= 141, 133)	38.3 25.7%	37.6 24.9%
All cycles (n=149, 151)	58.4 39.2%	56.3 37.3%

6. Secondary Outcome

Title	Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting
Description	Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Time Frame	From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Measure Participants	149	151
Cycle 1 (n=149, 151)	2.0 1.3%	5.3 3.5%
Cycle 2 (n=145, 144)	0.0 0%	2.1 1.4%
Cycle 3 (n=142, 139)	0.0 0%	2.2 1.5%
Cycle 4 (n=141, 133)	2.8 1.9%	3.8 2.5%
All cycles (n=149, 151)	4.7 3.2%	6.6 4.4%

7. Secondary Outcome

Title	Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles
Description	Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.
Time Frame	From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	General Education DVD	Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Measure Participants	149	151
Cycle 1 (n=149, 151)	74.5 50%	73.5 48.7%
Cycle 2 (n=145, 144)	69.0 46.3%	65.3 43.2%
Cycle 3 (n=142, 139)	65.5 44%	66.2 43.8%
Cycle 4 (n=141, 143)	68.8 46.2%	69.2 45.8%
All cycles (n=149, 151)	85.2 57.2%	80.1 53%

Adverse Events

Time Frame	From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks.
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. All sparticipants included in the analysis received at least one dose of pegfilgrastim.
Arm/Group Title	General Chemotherapy Education DVD		Bone Pain Education DVD
Arm/Group Description	Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.		Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
All Cause Mortality
	General Chemotherapy Education DVD		Bone Pain Education DVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	General Chemotherapy Education DVD		Bone Pain Education DVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/149 (10.7%)		20/151 (13.2%)
Blood and lymphatic system disorders
Anaemia	0/149 (0%)		1/151 (0.7%)
Febrile neutropenia	7/149 (4.7%)		4/151 (2.6%)
Neutropenia	1/149 (0.7%)		2/151 (1.3%)
Pancytopenia	1/149 (0.7%)		0/151 (0%)
Cardiac disorders
Atrial fibrillation	2/149 (1.3%)		0/151 (0%)
Cardiac failure congestive	0/149 (0%)		1/151 (0.7%)
Gastrointestinal disorders
Abdominal pain	0/149 (0%)		1/151 (0.7%)
Diarrhoea	2/149 (1.3%)		3/151 (2%)
Dyspepsia	0/149 (0%)		1/151 (0.7%)
Gastritis haemorrhagic	0/149 (0%)		1/151 (0.7%)
Nausea	2/149 (1.3%)		1/151 (0.7%)
Vomiting	1/149 (0.7%)		2/151 (1.3%)
General disorders
Asthenia	0/149 (0%)		2/151 (1.3%)
Pain	1/149 (0.7%)		0/151 (0%)
Pyrexia	0/149 (0%)		1/151 (0.7%)
Infections and infestations
Bacteraemia	1/149 (0.7%)		0/151 (0%)
Clostridium difficile colitis	1/149 (0.7%)		0/151 (0%)
Colonic abscess	1/149 (0.7%)		0/151 (0%)
Diarrhoea infectious	1/149 (0.7%)		0/151 (0%)
Diverticulitis	1/149 (0.7%)		1/151 (0.7%)
Gastroenteritis	0/149 (0%)		1/151 (0.7%)
Influenza	0/149 (0%)		2/151 (1.3%)
Localised infection	0/149 (0%)		1/151 (0.7%)
Pharyngitis	0/149 (0%)		1/151 (0.7%)
Pneumonia	0/149 (0%)		1/151 (0.7%)
Rectal abscess	0/149 (0%)		1/151 (0.7%)
Sepsis	0/149 (0%)		1/151 (0.7%)
Sepsis syndrome	0/149 (0%)		1/151 (0.7%)
Sinusitis	1/149 (0.7%)		1/151 (0.7%)
Urinary tract infection	1/149 (0.7%)		0/151 (0%)
Urinary tract infection bacterial	0/149 (0%)		1/151 (0.7%)
Metabolism and nutrition disorders
Dehydration	1/149 (0.7%)		1/151 (0.7%)
Lactic acidosis	1/149 (0.7%)		0/151 (0%)
Musculoskeletal and connective tissue disorders
Bone pain	1/149 (0.7%)		0/151 (0%)
Musculoskeletal chest pain	1/149 (0.7%)		1/151 (0.7%)
Myalgia	0/149 (0%)		1/151 (0.7%)
Nervous system disorders
Sinus headache	1/149 (0.7%)		0/151 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional	1/149 (0.7%)		0/151 (0%)
Hypoxia	0/149 (0%)		1/151 (0.7%)
Pulmonary embolism	0/149 (0%)		2/151 (1.3%)
Pulmonary oedema	0/149 (0%)		2/151 (1.3%)
Respiratory failure	0/149 (0%)		1/151 (0.7%)
Skin and subcutaneous tissue disorders
Decubitus ulcer	0/149 (0%)		1/151 (0.7%)
Rash	1/149 (0.7%)		0/151 (0%)
Stevens-Johnson syndrome	0/149 (0%)		1/151 (0.7%)
Surgical and medical procedures
Hysterectomy	1/149 (0.7%)		0/151 (0%)
Other (Not Including Serious) Adverse Events
	General Chemotherapy Education DVD		Bone Pain Education DVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	138/149 (92.6%)		144/151 (95.4%)
Blood and lymphatic system disorders
Anaemia	23/149 (15.4%)		29/151 (19.2%)
Leukocytosis	3/149 (2%)		9/151 (6%)
Neutropenia	18/149 (12.1%)		20/151 (13.2%)
Cardiac disorders
Palpitations	2/149 (1.3%)		8/151 (5.3%)
Eye disorders
Lacrimation increased	8/149 (5.4%)		3/151 (2%)
Gastrointestinal disorders
Constipation	43/149 (28.9%)		54/151 (35.8%)
Diarrhoea	52/149 (34.9%)		51/151 (33.8%)
Dyspepsia	14/149 (9.4%)		20/151 (13.2%)
Gastrooesophageal reflux disease	9/149 (6%)		8/151 (5.3%)
Nausea	87/149 (58.4%)		86/151 (57%)
Oral pain	6/149 (4%)		9/151 (6%)
Stomatitis	18/149 (12.1%)		22/151 (14.6%)
Vomiting	21/149 (14.1%)		17/151 (11.3%)
General disorders
Asthenia	10/149 (6.7%)		8/151 (5.3%)
Fatigue	87/149 (58.4%)		97/151 (64.2%)
Mucosal inflammation	8/149 (5.4%)		13/151 (8.6%)
Oedema peripheral	9/149 (6%)		14/151 (9.3%)
Pain	10/149 (6.7%)		8/151 (5.3%)
Pyrexia	12/149 (8.1%)		16/151 (10.6%)
Infections and infestations
Cellulitis	8/149 (5.4%)		0/151 (0%)
Upper respiratory tract infection	5/149 (3.4%)		8/151 (5.3%)
Urinary tract infection	7/149 (4.7%)		8/151 (5.3%)
Metabolism and nutrition disorders
Decreased appetite	28/149 (18.8%)		22/151 (14.6%)
Dehydration	13/149 (8.7%)		10/151 (6.6%)
Hypokalaemia	10/149 (6.7%)		13/151 (8.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	24/149 (16.1%)		20/151 (13.2%)
Back pain	17/149 (11.4%)		22/151 (14.6%)
Bone pain	47/149 (31.5%)		48/151 (31.8%)
Myalgia	15/149 (10.1%)		11/151 (7.3%)
Pain in extremity	14/149 (9.4%)		10/151 (6.6%)
Nervous system disorders
Dizziness	11/149 (7.4%)		13/151 (8.6%)
Dysgeusia	28/149 (18.8%)		26/151 (17.2%)
Headache	39/149 (26.2%)		45/151 (29.8%)
Neuropathy peripheral	17/149 (11.4%)		11/151 (7.3%)
Psychiatric disorders
Anxiety	6/149 (4%)		15/151 (9.9%)
Insomnia	21/149 (14.1%)		19/151 (12.6%)
Respiratory, thoracic and mediastinal disorders
Cough	14/149 (9.4%)		20/151 (13.2%)
Dyspnoea	8/149 (5.4%)		8/151 (5.3%)
Oropharyngeal pain	9/149 (6%)		16/151 (10.6%)
Skin and subcutaneous tissue disorders
Alopecia	49/149 (32.9%)		59/151 (39.1%)
Rash	13/149 (8.7%)		10/151 (6.6%)
Vascular disorders
Flushing	8/149 (5.4%)		5/151 (3.3%)
Hot flush	8/149 (5.4%)		10/151 (6.6%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.