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

Breast Cancer Clinical Trial

— PROSPECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495155
• Other study ID #: HUM00095498
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: July 25, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Insomnia
• Pain

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 through non-pharmacologic approaches.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	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.	8 weeks	No

External Links

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