Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer; Fatigue; Pain; Insomnia

• Registration Number: NCT02495155
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-13
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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:

  1. 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)
  2. Insomnia in the week prior to enrollment
  3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in patient-reported symptom with use of PROSPECT for 8 weeks	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

Name	Time	Method
Acceptability of the PROSPECT intervention based on patient self-report	8 weeks	To obtain preliminary data about the acceptability and usability of the intervention in this patient population.

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States