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OpenTrials
Completed

NCT Number: NCT02495155

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Dyssomnias Fatigue Insomnia Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Improvement in patient-reported symptom with use of PROSPECT for 8 weeks

    Time frame: 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 outcomes

  1. Acceptability of the PROSPECT intervention based on patient self-report

    Time frame: 8 weeks

    To obtain preliminary data about the acceptability and usability of the intervention in this patient population.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: PROSPECT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2015
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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