Overview

This trial is active, not recruiting.

Condition breast carcinoma
Treatments quality-of-life assessment, questionnaire administration
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date October 2005
End date January 2100
Trial size 684 participants
Trial identifier NCT00115505, CALGB-70301, CDR0000433266, NCI-2015-00210, U10CA031946

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 patient's or their spouse's 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients complete the QOL Assessments comprising the Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and 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.
quality-of-life assessment Quality of Life Assessment
Complete Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and EQ-5D and QOL Assessment Form, EORTC QLQ-C30 and EORTC QLQ-BR23
questionnaire administration
Complete the Employment and Informal Care Cost Assessment and Peripheral Neuropathy Assessments

Primary Outcomes

Measure
Degree that symptoms interfere with patient functioning according to the National Cancer Institute (NCI) Common Toxicity Criteria
time frame: Up to 18 months
Relative duration that symptoms interfere with patient functioning according to the NCI Common Toxicity Criteria
time frame: Up to 18 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Patient must be registered to CALGB 40101 - Patient must be able to communicate in English

Additional Information

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
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 (i.e., 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 (C)30 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.