Clinical trial NCT02712437: Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer
Official title: Prospective Study Evaluating the Use of PROSPECT, a Cognitive Behavioral Therapy-based Internet Module, to Reduce Insomnia in Patients With Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Insomnia
Keywords: Insomnia
Quality of Life
Cognitive behavioral therapy
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Women with early stage breast cancer may experience difficulty falling asleep or staying asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia. Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of medications for sleep and an overall decrease in quality of life.

The investigators have developed an internet-based website that is designed to help people manage symptoms typically experienced by breast cancer survivors, including insomnia, fatigue, pain and overall poor quality of life. The investigators want to learn whether this type of treatment can reduce chronic insomnia and improve the way subjects feel using both questionnaires and a special form of a wrist watch. This information may help the investigators better manage sleep difficulties in subjects who experience these symptoms after diagnosis of their breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score \>14
2. Insomnia present for \> 30 days per patient report
3. Female gender
4. Histologically proven stage 0-III invasive carcinoma of the breast

   a. Patient's must have completed primary surgical resection at least 2 weeks prior to enrollment, radiation at least 2 weeks prior to enrollment and/or cytotoxic chemotherapy at least 6 weeks prior to enrollment in the study
5. ECOG performance status 0-2
6. Ability to operate the accelerometer (Actiwatch Spectrum Pro)
7. The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent document

Exclusion Criteria:

1. Subjects who do not have access to the internet to use the internet-based module, PROSPECT
2. Initiation of hormone therapy \<4 weeks prior to enrollment in the study
3. Initiation of sleep aids, including over-the-counter or prescription medications taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for \< 4 weeks prior to enrollment in the study
4. Use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy
5. History of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (Rheumatoid Arthritis, Systemic Lupus Spondyloarthropathy, Psoriatic Arthritis, Polymyalgia Rheumatica), Parkinson's disease and cancer involving the bone
6. Second or third shift workers or others with non-traditional sleep schedules
7. Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Sleep Disturbance as measured by Actigraphy
timeFrame: 6 weeks
Other outcomes:
measure: Change in use of sleep aids
timeFrame: 6 weeks
measure: Change in Quality of Life
timeFrame: 6 weeks
measure: Change in Fear of Cancer Recurrence
timeFrame: 6 weeks
Locations:
city: Ann Arbor
country: United States
facility: Unvisterity of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Daniel F Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References: