Breast Cancer Clinical Trial

Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer

Summary

In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Female
Stage 0-III invasive carcinoma of the breast
Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.

Must report at least one of the following:

Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
Insomnia in the week prior to enrollment
Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
Has access to and is able to operate a computer with internet access.
Able to read and understand English.
Willing and able to sign an informed consent document.

Exclusion Criteria:

- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep

Study is for people with:

Breast Cancer

Estimated Enrollment:

45

Study ID:

NCT02495155

Recruitment Status:

Completed

Sponsor:

University of Michigan

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There is 1 Location for this study

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University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

45

Study ID:

NCT02495155

Recruitment Status:

Completed

Sponsor:


University of Michigan

How clear is this clinincal trial information?

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