Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Chronic Pain, Insomnia Sleep Studies, Other Indications |
| Therapuetic Areas: | Musculoskeletal, Oncology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/27/2016 |
| Start Date: | June 2015 |
| End Date: | June 2016 |
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.
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.
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:
1. 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)
2. Insomnia in the week prior to enrollment
3. 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
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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