NCT01941784

Brief Summary

This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 25, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

January 25, 2019

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

September 10, 2013

Last Update Submit

January 23, 2019

Conditions

Stage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate

    Reasons why participants are not eligible will be reported and inclusion/exclusion criteria will be reevaluated. The proportion of participants who completed all sessions and testing visits will be estimated and compared. Barriers to recruitment (e.g., timing of intervention, inconvenience, time constraints, participant feeling too sick) will be recorded to assist in designing the larger trial.

    Baseline

Secondary Outcomes (9)

  • Effect of the intervention on body composition

    Up to 52 weeks

  • Effect of the intervention on self-efficacy

    Up to 52 weeks

  • Effect of the intervention on perceived stress

    Up to 52 weeks

  • Effect of the intervention on fatigue

    Up to 52 weeks

  • Effect of the intervention on 6 minute walk distance

    Up to 52 weeks

  • +4 more secondary outcomes

Study Arms (1)

Supportive care (health education program)

EXPERIMENTAL

See Detailed Description.

Other: educational interventionOther: counseling interventionBehavioral: telephone-based interventionOther: questionnaire administrationProcedure: quality-of-life assessment

Interventions

educational interventionOTHER

Undergo health education program

Also known as: intervention, educational
Supportive care (health education program)
counseling interventionOTHER

Undergo health education program

Also known as: counseling and communications studies
Supportive care (health education program)
telephone-based interventionBEHAVIORAL

Receive follow-up phone calls

Supportive care (health education program)
questionnaire administrationOTHER

Ancillary studies

Supportive care (health education program)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Supportive care (health education program)

Eligibility Criteria

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

You may qualify if:

  • Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy
  • Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) \> 20
  • Treating physician approval to participate in study
  • Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

You may not qualify if:

  • Diagnosis of recurrent breast cancer
  • Women who are already participating in a formal or medically prescribed weight management program
  • Women who have already completed more than two rounds of chemotherapy
  • Women who are pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, EducationalMethodsCounseling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative TechniquesMental Health ServicesBehavioral Disciplines and Activities

Study Officials

  • Shannon Mihalko

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

November 25, 2013

Primary Completion

March 1, 2017

Study Completion

April 12, 2017

Last Updated

January 25, 2019

Record last verified: 2018-07

Locations

US(1)