Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Fatigue

Pain

Breast Diseases

Skin Diseases

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.

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.

PROSPECT

Norah L Henry, MD, PhD

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.

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

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.

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

University of Michigan

Associate Professor

Nervous System Diseases

Behaviors and Mental Disorders

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Participants who have received treatment for early stage breast cancer and who experience chronic insomnia as assessed by difficulty sleeping for \>30 days with an insomnia severity index score of \>14. Participants will complete baseline symptom questionnaires and actigraphy, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 6 weeks. Participants will then repeat questionnaires and actigraphy at 6 weeks and questionnaires at 12 weeks.

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, including insomnia, through non-pharmacologic approaches.

Daniel F Hayes, MD

Women with early stage breast cancer may experience difficulty falling asleep or staying asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia. Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of medications for sleep and an overall decrease in quality of life.

The investigators have developed an internet-based website that is designed to help people manage symptoms typically experienced by breast cancer survivors, including insomnia, fatigue, pain and overall poor quality of life. The investigators want to learn whether this type of treatment can reduce chronic insomnia and improve the way subjects feel using both questionnaires and a special form of a wrist watch. This information may help the investigators better manage sleep difficulties in subjects who experience these symptoms after diagnosis of their breast cancer.

Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer

Prospective Study Evaluating the Use of PROSPECT, a Cognitive Behavioral Therapy-based Internet Module, to Reduce Insomnia in Patients With Early Stage Breast Cancer

A review of the patient's medication list will be conducted at baseline and 6 weeks to determine change in use of sleep aids for chronic insomnia during study participation

Quality of life will be measured through the use of a validated survey called Functional Assessment of Cancer Therapy-Endocrine Symptoms

Fear of recurrence will be measured through the use of a validated survey called Assessment of Cancer Survivors

Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index

Sleep disturbance will be measured through the use of actigraphy watches to be worn for 7 days at baseline and 7 days after 6 weeks of the intervention

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer	NCT02495155	Breast Cancer Fatigue Insomnia Pain	PROSPECT	18 Years -	University of Michigan
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer	NCT02495155	Breast Cancer Fatigue Insomnia Pain	PROSPECT	18 Years -	University of Michigan
Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer	NCT02712437	Breast Cancer Insomnia	PROSPECT	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for prospect

Every month we try and update this database with for prospect cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prospect

Every month we try and update this database with for prospect cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prospect cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.