An interventional study of PROSPECT in Breast Cancer and Insomnia, sponsored by University of Michigan Rogel Cancer Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-08.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 4 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Participants who have received treatment for early stage breast cancer and who experience chronic insomnia as assessed by difficulty sleeping for \>30 days with an insomnia severity index score of \>14. Participants will complete baseline symptom questionnaires and actigraphy, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 6 weeks. Participants will then repeat questionnaires and actigraphy at 6 weeks and questionnaires at 12 weeks.
Behavioral: PROSPECT
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, including insomnia, through non-pharmacologic approaches.
Change in Insomnia Severity Index
Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index
Time frame: 6 weeks
Change in Sleep Disturbance as measured by Actigraphy
Sleep disturbance will be measured through the use of actigraphy watches to be worn for 7 days at baseline and 7 days after 6 weeks of the intervention
Time frame: 6 weeks
Change in use of sleep aids
A review of the patient's medication list will be conducted at baseline and 6 weeks to determine change in use of sleep aids for chronic insomnia during study participation
Time frame: 6 weeks
Change in Quality of Life
Quality of life will be measured through the use of a validated survey called Functional Assessment of Cancer Therapy-Endocrine Symptoms
Time frame: 6 weeks
Change in Fear of Cancer Recurrence
Fear of recurrence will be measured through the use of a validated survey called Assessment of Cancer Survivors
Time frame: 6 weeks
Plan to share: No
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This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center