Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer

NCT02712437 | Terminated DMC

• 1 other identifier: UMCC 2015.168
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Insomnia

Keywords

Insomnia; Quality of Life; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index

  Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index

  6 weeks

Secondary Outcomes (1)

• Change in Sleep Disturbance as measured by Actigraphy

  6 weeks

Other Outcomes (3)

• Change in use of sleep aids

  6 weeks

• Change in Quality of Life

  6 weeks

• Change in Fear of Cancer Recurrence

  6 weeks

Study Arms (1)

PROSPECT

EXPERIMENTAL

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

Interventions

PROSPECT BEHAVIORAL

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.

PROSPECT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score \>14
• Insomnia present for \> 30 days per patient report
• Female gender
• 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
• ECOG performance status 0-2
• Ability to operate the accelerometer (Actiwatch Spectrum Pro)
• 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

You may not qualify if:

• Subjects who do not have access to the internet to use the internet-based module, PROSPECT
• Initiation of hormone therapy \<4 weeks prior to enrollment in the study
• 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
• Use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy
• 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
• Second or third shift workers or others with non-traditional sleep schedules
• Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

Unvisterity of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Links

• For more information about clinical trials at the University of Michigan, including this study

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Daniel F Hayes, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: March 16, 2016
• Primary Completion: March 9, 2017
• Study Completion: March 9, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)