Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115505
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2005-06-22
Brief Title:
Quality of Life Employment and Informal Care Costs in Women Who Are Receiving Chemotherapy for Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Quality of Life Employment and Informal Care Cost Analysis in Women Receiving Adjuvant Chemotherapy for Breast Cancer With 0-3 Positive Axillary Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research trial studies quality of life employment and informal care cost analysis in patients with breast cancer receiving chemotherapy This trial assesses how quality of life has been affected by cancer if cancer and its treatment have caused in changes in the patients or their spouses employment and how they have affected the patient and their extended family and the impact of peripheral neuropathy caused by chemotherapy on quality of life Learning about quality of life and informal care costs may help doctors better understand how patients feel during treatment what effects the medicines are having and in the future may help both patients and doctors as they decide which medicines to use to treat cancer
Detailed Description:
PRIMARY OBJECTIVES
I To compare the individual treatment arms relative to the degree that symptoms interfere with patient functioning and to characterize and compare the relative duration that symptoms interfere with patient functioning
II To assess the employment consequences of cancer and its treatment on the patient and extended family and to compare treatment arms relative to these consequences
III To determine the prevalence and severity of peripheral neuropathy in breast cancer patients treated by adjuvant chemotherapy with dose dense every two weeks paclitaxel for 4 cycles from study entry to 5 years after the start of treatment
SECONDARY OBJECTIVES
I To identify baseline characteristics that are predictive for patients being more vulnerable to experiencing side effects which significantly interfere with patient functioning
II To identify and characterize the relative importance of the reasons that patients decide to participate in the treatment study Cancer and Leukemia Group B CALGB 40101 and how those reasons might change as a consequence of their experience with treatment
III To compare the quality-adjusted life years between adjuvant chemotherapy AC and paclitaxel or between short and long schedules regardless of the other factor
IV To measure over the course of adjuvant therapy the type and amount of informal care needs of the patient
V Using a societal perspective estimate and compare the economic consequences on employment and informal care needs
VI To determine if specific identifiable clinical adverse events ie neuropathy or fatigue are associated with greater economic consequences
VII To examine factors which are predictive of a patient being employed during and after cancer treatment
VIII To compare the prevalence and severity of peripheral neuropathy in breast cancer patients treated by dose dense paclitaxel to those patients treated with dose dense CA cyclophosphamide and doxorubicin
IX To conduct an exploratory examination of the relationship between the severity of peripheral neuropathy after paclitaxel treatment 4 and 6 cycles and breast cancer patients functioning including physical psychological and social functioning
X To validate the neurotoxicity items in the Symptoms in Relation to Patient Functioning Survey C-1271 used in this protocol by correlating its results with the Functional Assessment of Cancer Therapy FACT-Neurotoxicity Subscale C-669 and the European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-Core C30 and Breast Cancer module C-259 and C-618
OUTLINE
Patients complete the QOL Assessments comprising the Subjective Significance Questionnaire Medical Outcome Study MOS Social Support Survey Patient Preferences CALGB Background Information and European Quality of Life 5-Dimensions EQ-5D and QOL Assessment Form Employment and Informal Care Cost Assessments and Peripheral Neuropathy of the FACT-NTX subscale at baseline 29-42 and 57-70 days and at 9 and 18 months Patients meeting the cut-off score for peripheral neuropathy on the FACT-NTX subscale at 18 months complete the Symptoms in Relation to Patient Functioning Survey FACT-NTX subscale the EORTC QLQ-C30 EORTC QLQ-BR23 and the Medications Used for Treating Peripheral Neuropathy at 24 36 48 and 60 months
I To compare the individual treatment arms relative to the degree that symptoms interfere with patient functioning and to characterize and compare the relative duration that symptoms interfere with patient functioning
II To assess the employment consequences of cancer and its treatment on the patient and extended family and to compare treatment arms relative to these consequences
III To determine the prevalence and severity of peripheral neuropathy in breast cancer patients treated by adjuvant chemotherapy with dose dense every two weeks paclitaxel for 4 cycles from study entry to 5 years after the start of treatment
SECONDARY OBJECTIVES
I To identify baseline characteristics that are predictive for patients being more vulnerable to experiencing side effects which significantly interfere with patient functioning
II To identify and characterize the relative importance of the reasons that patients decide to participate in the treatment study Cancer and Leukemia Group B CALGB 40101 and how those reasons might change as a consequence of their experience with treatment
III To compare the quality-adjusted life years between adjuvant chemotherapy AC and paclitaxel or between short and long schedules regardless of the other factor
IV To measure over the course of adjuvant therapy the type and amount of informal care needs of the patient
V Using a societal perspective estimate and compare the economic consequences on employment and informal care needs
VI To determine if specific identifiable clinical adverse events ie neuropathy or fatigue are associated with greater economic consequences
VII To examine factors which are predictive of a patient being employed during and after cancer treatment
VIII To compare the prevalence and severity of peripheral neuropathy in breast cancer patients treated by dose dense paclitaxel to those patients treated with dose dense CA cyclophosphamide and doxorubicin
IX To conduct an exploratory examination of the relationship between the severity of peripheral neuropathy after paclitaxel treatment 4 and 6 cycles and breast cancer patients functioning including physical psychological and social functioning
X To validate the neurotoxicity items in the Symptoms in Relation to Patient Functioning Survey C-1271 used in this protocol by correlating its results with the Functional Assessment of Cancer Therapy FACT-Neurotoxicity Subscale C-669 and the European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-Core C30 and Breast Cancer module C-259 and C-618
OUTLINE
Patients complete the QOL Assessments comprising the Subjective Significance Questionnaire Medical Outcome Study MOS Social Support Survey Patient Preferences CALGB Background Information and European Quality of Life 5-Dimensions EQ-5D and QOL Assessment Form Employment and Informal Care Cost Assessments and Peripheral Neuropathy of the FACT-NTX subscale at baseline 29-42 and 57-70 days and at 9 and 18 months Patients meeting the cut-off score for peripheral neuropathy on the FACT-NTX subscale at 18 months complete the Symptoms in Relation to Patient Functioning Survey FACT-NTX subscale the EORTC QLQ-C30 EORTC QLQ-BR23 and the Medications Used for Treating Peripheral Neuropathy at 24 36 48 and 60 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000433266 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-70301 | None | None | None |
| NCI-2015-00210 | REGISTRY | None | None |
| U10CA031946 | NIH | None | None |