NCT01351844

Brief Summary

Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. The purpose of this study is to see whether a computer-based educational module is a feasible intervention to help address these symptoms. If the patients agree to participate, a research coordinator will test their grip strength and give them a computer log-on code. They will be shown how to log-on to complete the educational module and a few simple questionnaires. Patients have the option to do this from home if they wish. In 3 months time, the investigators will ask patients to return to the clinic and have another grip strength evaluation and complete some additional questionnaires. The computer module and the follow up visit will each take about 30 minutes of time.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

May 10, 2011

Last Update Submit

August 28, 2017

Conditions

Breast CancerArthralgia

Keywords

Aromatase inhibitorArthralgia SyndromeExercise

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    This study is designed as a pilot study to assess feasibility of this educational intervention in a small population of only 40 patients. Patients will be given the option to complete the module from home. The primary endpoint will be patient completion of the educational module and follow-up questionnaires.

    3 months

Secondary Outcomes (1)

  • Grip Strength

    3 months

Study Arms (2)

Education and exercise intervention

ACTIVE COMPARATOR

The "intervention" module will contain a brief series of slides with a voice-over. An occupational therapist will review recommended exercises.

Behavioral: Education and exercise intervention

Education and general exercise

PLACEBO COMPARATOR

The "control" module will contain a brief series of slides with a voice-over. A physical therapist with experience in treating breast cancer patients will demonstrate a series of 4-5 general stretching and toning exercises.

Behavioral: Education and General Exercise

Interventions

Education and exercise interventionBEHAVIORAL

An occupational therapist who has clinical experience in hand therapy for breast cancer patients with arthralgia syndrome, will review 4-5 exercises which improve hand range of motion and reduce hand stiffness.

Education and exercise intervention
Education and General ExerciseBEHAVIORAL

A physical therapist with experience in treating breast cancer patients with lymphedema will demonstrate a series of 4-5 general stretching and toning exercises.

Education and general exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal stage I-III breast cancer patients
  • Starting or about to start aromatase inhibitor
  • English speaking with ability to read, write and use a computer to watch and listen to an educational module.
  • Able to give informed consent

You may not qualify if:

  • Aromatase inhibitor (AI) use for more than 6 months
  • Metastatic breast cancer
  • Non-English speaking, or unable to read, write or use a computer to watch and listen to an educational module.
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Shanmugam

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsArthralgiaMotor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Victoria K Shanmugam, MD

    Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 11, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

US(1)