Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
Completed · Not applicable
Conditions studied: Breast Cancer, Fatigue, Insomnia, Pain
In brief
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.
Key facts
- Study ID
- NCT02495155
- Run by
- University of Michigan
- People needed
- 45
- Starts
- 2015-06-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-07-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
Where it is running
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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