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Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00352027
First received: July 13, 2006
Last updated: September 19, 2016
Last verified: September 2016
Results First Received: April 27, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hodgkin's Lymphoma
Interventions: Drug: Adriamycin®
Drug: Vinblastine
Drug: Nitrogen Mustard
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Bleomycin
Drug: Etoposide
Drug: Prednisone
Biological: G-CSF
Procedure: Radiotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled between July 2006 and March 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was determined to be ineligible after enrollment and prior to start of therapy.

Reporting Groups
  Description
Stanford V Chemotherapy

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.


Participant Flow:   Overall Study
    Stanford V Chemotherapy
STARTED   80 
COMPLETED   77 
NOT COMPLETED   3 
Progressive disease                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stanford V Chemotherapy

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.


Baseline Measures
   Stanford V Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 80 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.10  (3.15) 
Gender 
[Units: Participants]
 
Female   46 
Male   34 
Participating Site Location 
[Units: Participants]
 
Dana Farber Cancer Institute, Boston, MA   21 
Main Medical Center, Portland, ME   2 
Massachusetts General Hospital, Boston, MA   1 
Rady Children's Hospital, San Diego, CA   1 
St. Jude Children's Research Hospital, Memphis, TN   33 
Stanford University Medical Center, Palo Alto, CA   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   3-year Event-Free Survival Probability   [ Time Frame: 3 years ]

2.  Secondary:   Disease Failure Rate Within Radiation Fields   [ Time Frame: 3 years ]

3.  Secondary:   Local and Distant Failure for Children Treated With Tailored-field Radiation   [ Time Frame: from first enrollment date up to 3 years follow-up ]

4.  Secondary:   Prognostic Factors for Treatment Failure: Age   [ Time Frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up ]

5.  Secondary:   Patient Quality of Life (QoL), PedsQL v.4.0: Total Score   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

6.  Secondary:   Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

7.  Secondary:   Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

8.  Secondary:   Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

9.  Secondary:   Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

10.  Secondary:   Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

11.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Total Score   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

12.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

13.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Nausea   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

14.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

15.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

16.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Worry   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

17.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

18.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

19.  Secondary:   Patient Quality of Life (QoL), PedsQL v.3.0: Communication   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

20.  Secondary:   Patient Quality of Life (QoL), Symptom Distress Scale   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

21.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

22.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

23.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

24.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

25.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

26.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

27.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

28.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

29.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

30.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

31.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

32.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

33.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

34.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

35.  Secondary:   Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

36.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

37.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

38.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

39.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

40.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

41.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

42.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

43.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

44.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

45.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

46.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

47.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

48.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

49.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

50.  Secondary:   Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]

51.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score   [ Time Frame: 6 months after the completion of therapy ]

52.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning   [ Time Frame: 6 months after the completion of therapy ]

53.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health   [ Time Frame: 6 months after the completion of therapy ]

54.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning   [ Time Frame: 6 months after the completion of therapy ]

55.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning   [ Time Frame: 6 months after the completion of therapy ]

56.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning   [ Time Frame: 6 months after the completion of therapy ]

57.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score   [ Time Frame: 6 months after the completion of therapy ]

58.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt   [ Time Frame: 6 months after the completion of therapy ]

59.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea   [ Time Frame: 6 months after the completion of therapy ]

60.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety   [ Time Frame: 6 months after the completion of therapy ]

61.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety   [ Time Frame: 6 months after the completion of therapy ]

62.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry   [ Time Frame: 6 months after the completion of therapy ]

63.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems   [ Time Frame: 6 months after the completion of therapy ]

64.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance   [ Time Frame: 6 months after the completion of therapy ]

65.  Secondary:   Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication   [ Time Frame: 6 months after the completion of therapy ]

66.  Secondary:   3-year Event-free Survival (EFS) Probability   [ Time Frame: 3 years ]

67.  Secondary:   3-year Overall Survival (OS) Probability   [ Time Frame: 3-years ]

68.  Secondary:   3-year Local Failure-free Survival Probability   [ Time Frame: 3 years ]

69.  Secondary:   Toxicities With Grade >1   [ Time Frame: 3 years ]

70.  Secondary:   Prognostic Factors for Treatment Failure: Gender   [ Time Frame: 3 years follow-up ]

71.  Secondary:   Prognostic Factors for Treatment Failure: Histology   [ Time Frame: 3 years follow-up ]

72.  Secondary:   Prognostic Factors for Treatment Failure: Stage   [ Time Frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up ]

73.  Secondary:   Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy   [ Time Frame: 1, 2, 5, and 10 years post therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Monika Metzger, MD
Organization: S.t Jude Children's Research Hospital
phone: 901-595-4974
e-mail: monika.metzger@stjude.org



Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00352027     History of Changes
Other Study ID Numbers: HOD05
Study First Received: July 13, 2006
Results First Received: April 27, 2016
Last Updated: September 19, 2016
Health Authority: United States: Institutional Review Board