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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02712437
• Other study ID #: UMCC 2015.168
• Status: Terminated
• Phase: N/A
• First received: March 15, 2016
• Last updated: September 5, 2017
• Start date: March 16, 2016
• Est. completion date: March 9, 2017

Study information

• Verified date: September 2017
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Unvisterity of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	Change in Insomnia Severity Index	Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index	6 weeks
Secondary	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