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

NCT02495155 | Completed DMC

• 1 other identifier: HUM00095498
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Fatigue; Insomnia; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Acceptability of the PROSPECT intervention based on patient self-report

  8 weeks

Study Arms (3)

Fatigue

ACTIVE COMPARATOR

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.

Behavioral: PROSPECT

Treatment-related Pain

ACTIVE COMPARATOR

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.

Behavioral: PROSPECT

Insomnia

ACTIVE COMPARATOR

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.

Behavioral: PROSPECT

Interventions

PROSPECT BEHAVIORAL

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.

Fatigue; Insomnia; Treatment-related Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Links

• for information about clinical trials at University of Michigan, including this one

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 13, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

US (1)