Back to resultsInitial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer (PROSPECT)
Primary Purpose
Breast Cancer, Fatigue, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROSPECT
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female
- Stage 0-III invasive carcinoma of the breast
- Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
- Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
Must report at least one of the following:
- Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
- Insomnia in the week prior to enrollment
- Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
- Has access to and is able to operate a computer with internet access.
- Able to read and understand English.
- Willing and able to sign an informed consent document.
Exclusion Criteria:
- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
Sites / Locations
- University of Michigan Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Fatigue
Treatment-related Pain
Insomnia
Arm Description
Participants who have received treatment for early stage breast cancer and who experience fatigue, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
Participants who have received treatment for early stage breast cancer and who experience pain, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
Participants who have received treatment for early stage breast cancer and who experience insomnia, assessed as difficulty sleeping over the last week, yes or no, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
Outcomes
Primary Outcome Measures
Improvement in patient-reported symptom with use of PROSPECT for 8 weeks
To obtain preliminary data about the efficacy of the intervention in this patient population. The investigators will assess change in the participant's primary reported symptom (pain, insomnia, or fatigue) with 8 weeks of the intervention.
Secondary Outcome Measures
Acceptability of the PROSPECT intervention based on patient self-report
To obtain preliminary data about the acceptability and usability of the intervention in this patient population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02495155
Brief Title
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
Acronym
PROSPECT
Official Title
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue, Insomnia, Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fatigue
Arm Type
Active Comparator
Arm Description
Participants who have received treatment for early stage breast cancer and who experience fatigue, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
Arm Title
Treatment-related Pain
Arm Type
Active Comparator
Arm Description
Participants who have received treatment for early stage breast cancer and who experience pain, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
Arm Title
Insomnia
Arm Type
Active Comparator
Arm Description
Participants who have received treatment for early stage breast cancer and who experience insomnia, assessed as difficulty sleeping over the last week, yes or no, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
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 through non-pharmacologic approaches.
Primary Outcome Measure Information:
Title
Improvement in patient-reported symptom with use of PROSPECT for 8 weeks
Description
To obtain preliminary data about the efficacy of the intervention in this patient population. The investigators will assess change in the participant's primary reported symptom (pain, insomnia, or fatigue) with 8 weeks of the intervention.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Acceptability of the PROSPECT intervention based on patient self-report
Description
To obtain preliminary data about the acceptability and usability of the intervention in this patient population.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Stage 0-III invasive carcinoma of the breast
Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
Must report at least one of the following:
Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
Insomnia in the week prior to enrollment
Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
Has access to and is able to operate a computer with internet access.
Able to read and understand English.
Willing and able to sign an informed consent document.
Exclusion Criteria:
- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norah L Henry, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
We'll reach out to this number within 24 hrs