Breast Cancer, Fatigue, Insomnia, Pain
Conditions
Brief 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.
Interventions
BEHAVIORALPROSPECT
PROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms through non-pharmacologic approaches.
Sponsors
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in patient-reported symptom with use of PROSPECT for 8 weeks | 8 weeks | To obtain preliminary data about the efficacy of the intervention in this patient population. The investigators will assess change in the participant's primary reported symptom (pain, insomnia, or fatigue) with 8 weeks of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the PROSPECT intervention based on patient self-report | 8 weeks | To obtain preliminary data about the acceptability and usability of the intervention in this patient population. |
Countries
United States
Outcome results
None listed