Quality of Life, Employment, and Informal Care Costs in Women Who Are Receiving Chemotherapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+226 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Craig A. Bunnell, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Inclusion Criteria

Patient must be registered to CALGB 40101

Patient must be able to communicate in Englis

Treatment Details

Interventions

• Quality-of-Life Assessment (Behavioural Intervention)
• Questionnaire Administration (Behavioural Intervention)

Participant Groups

Group I: Ancillary-Correlative (QOL, employment, informal care cost) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School