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

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT02495155

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Fatigue Insomnia Pain	Behavioral: PROSPECT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fatigue 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 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.
Active Comparator: Treatment-related Pain 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 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.
Active Comparator: Insomnia 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 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.

Arm

Intervention/Treatment

Active Comparator: Fatigue

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

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.

Active Comparator: Treatment-related Pain

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

Active Comparator: Insomnia

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Norah L Henry, MD, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

N. Lynn Henry, Associate Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT02495155

Other Study ID Numbers:

HUM00095498

First Posted:

Jul 13, 2015

Last Update Posted:

Jul 26, 2016

Last Verified:

Jul 1, 2016

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jul 26, 2016