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

Primary Purpose

Breast Cancer, Insomnia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PROSPECT

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Insomnia, Quality of Life, Cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Unvisterity of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PROSPECT

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02712437

First Posted

March 15, 2016

Last Updated

September 5, 2017

Sponsor

University of Michigan Rogel Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02712437

Brief Title

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

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated because of low accrual.

Study Start Date

March 16, 2016 (Actual)

Primary Completion Date

March 9, 2017 (Actual)

Study Completion Date

March 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Insomnia

Keywords

Insomnia, Quality of Life, Cognitive behavioral therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PROSPECT

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PROSPECT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Insomnia Severity Index

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in Sleep Disturbance as measured by Actigraphy

Description

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

Other Pre-specified Outcome Measures:

Title

Change in use of sleep aids

Description

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

Title

Change in Quality of Life

Description

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

Title

Change in Fear of Cancer Recurrence

Description

Fear of recurrence will be measured through the use of a validated survey called Assessment of Cancer Survivors

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel F Hayes, MD

Organizational Affiliation

University of Michigan Rogel Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Unvisterity of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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