NCT00933088

Brief Summary

The aims of this study are to determine the differential coping strategies used by adolescent daughters whose mothers have breast cancer, and how this relates to the stress responses they exhibit.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

July 2, 2009

Last Update Submit

June 23, 2016

Conditions

Keywords

adolescent coping strategiesstress responsebreast cancer

Outcome Measures

Primary Outcomes (1)

  • adolescent coping strategies and relationship to the stress response

    not more than one year past mother's diagnosis and treatment

Secondary Outcomes (2)

  • adolescent coping strategies by age

    not more than one year past mother's diagnosis and treatment

  • adolescent strategies by quality of maternal-adolescent relationship

    not more than one year past her diagnosis and treatment

Interventions

The study instruments will be given in the following order to the adolescent daughters: 1. Responses to Stress questionnaire; 2. Inventory of Peer and Family Attachment; 3. Youth Self-Report; and, 4. Adolescent data form. Mothers will be asked to complete data form.

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Adoelscent girls between the ages of 13 and 19 years; with a mother who was diagnosed with localized breast cancer (Stage II,II), who is not more than one year past her diagnosis and treatment, and attends the NYUMC or NYCHHC Cancer Center clinics.

You may qualify if:

  • For mothers:
  • women at any age
  • diagnosed with localized breast cancer
  • not more than one year past the initial breast cancer diagnosis and treatment
  • attending the New York University Medical Center (NYUMC) Cancer Center and/or Clinics for breast cancer treatment or follow-up
  • have a daughter between the ages of 13 and 19
  • where there are more than one adolescent daughter, all daughters can be included
  • For daughters:
  • adolescent girls between the ages of 13 and 19 years
  • with a mother who was diagnosed with localized breast cancer (Stage II,II), who is not more than one year past her diagnosis and treatment, and attends the NYUMC or NYCHHC Cancer Center clinics

You may not qualify if:

  • For mothers:
  • women who have recurrent breast cancer disease
  • have a second cancer diagnoses
  • have another chronic illness that they are currently being treated for
  • For daughters:
  • adolescent girls under the age of 13 years or over the age of 19
  • have been diagnosed previously with cancer themselves
  • have a chronic illness they are currently undergoing treatment for

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

New York University Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsFractures, Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Yelena Novik, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

June 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations