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

Prospective Study Evaluating the Use of PROSPECT, a Cognitive Behavioral Therapy-based Internet Module, to Reduce Insomnia in Patients With Early Stage Breast Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Insomnia
• Intervention / Treatment: Behavioral: PROSPECT

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Unvisterity of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PROSPECT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insomnia Severity Index	Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	6 weeks

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Daniel F Hayes, MD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2016
• Primary Completion (Actual): March 9, 2017
• Study Completion (Actual): March 9, 2017

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Quality of Life; Cognitive behavioral therapy; Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Neoplasms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UMCC 2015.168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO