Palbociclib in Real World Practice
- Conditions
- Advanced Breast CancerMetastatic Breast Cancer
- Registration Number
- NCT03280303
- Lead Sponsor
- Pfizer
- Brief Summary
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1285
Not provided
-
Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
-
Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
-
Patients on active treatment for malignancies other than ABC at the time of enrollment.
-
Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants According to Real-World Tumor Response From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.
Real-World Tumor Response Rate From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants.
Real World Progression Free Survival From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years) Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment.
Overall Survival From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years) Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive.
Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only Baseline (last observed measurement prior to treatment start date) ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only Month 1 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only Month 2 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only Month 3 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only Month 9 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only Month 12 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only Month 15 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only Month 18 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only Month 21 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only Month 24 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only Month 27 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only Month 30 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only Month 33 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only Month 36 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only Month 39 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only Month 42 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only Baseline (last observed measurement prior to treatment start date) The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only Month 1 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only Month 2 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only Month 3 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only Month 6 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only Month 15 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only Month 18 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only Month 21 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only Month 24 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only Month 27 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only Month 30 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only Month 33 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only Month 36 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only Month 39 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only Month 42 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only Baseline (last observed measurement prior to treatment start date) Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only Month 1 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only Month 2 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only Month 3 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only Month 6 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only Month 9 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only Month 18 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only Month 21 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only Month 24 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only Month 27 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only Month 30 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only Month 33 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only Month 36 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only Month 39 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only Month 42 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Number of Participants With Adverse Events From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.
Number of Participants With Serious Adverse Events From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
Number of Participants With Any Clinical Laboratory Abnormalities From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported.
ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only Month 6 ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only Month 9 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only Month 12 The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Baseline (last observed measurement prior to treatment start date) and Month 6 European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Baseline (last observed measurement prior to treatment start date) and Month 12 EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Baseline (last observed measurement prior to treatment start date) and Month 18 EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only Month 12 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only Month 15 Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (209)
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Grandview Cancer Center, Alabama Oncology
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Central Arkansas Radiation Therapy Institute
🇺🇸Stuttgart, Arkansas, United States
Sutter Auburn
🇺🇸Auburn, California, United States
AIS Cancer Center at Adventist Health Bakersfield
🇺🇸Bakersfield, California, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
Providence Health and Services Southern California
🇺🇸Burbank, California, United States
Enloe Regional Cancer Center
🇺🇸Chico, California, United States
Scroll for more (199 remaining)Alabama Oncology🇺🇸Birmingham, Alabama, United States