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Breast CancerNCT00933088

Adolescent Daughters' Response and Adjustment to Maternal Breast Cancer

An observational study of Breast Cancer, run by NYU Langone Health at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 19 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
questionnaires
How many people
43 participants
Where
2 sitesUnited States
Study dates
Jun 2008to Oct 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • Women only
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Bellevue Hospital Center

    New York, New York, 10016

  • New York University Cancer Center

    New York, New York, 10016

Other trials in United States

About this study

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.

Read the detailed description

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. Adolescent age, and their relationship with their mothers will also be examined in relation to their coping. This group of adolescent daughters has reported a 25% increased rate of stress responses, specifically anxiety and depression, than a normative sample and than sons. They additionally report emotional distress and worries, and fear engaging in health promoting activities. Forty percent of adolescent daughters who are initially diagnosed with depression, like those whose mothers have breast cancer, will experience a second bout of depression, and 70% of those will have a relapse in adulthood. The strategies that adolescents use to cope with stress are potentially important mediators of the impact of stress on current and future adjustment. Yet little is known about the differential coping strategies used when adolescent daughters are faced with their mothers' breast cancer, and how these mediate that impact. Additionally, the generalizability of the research findings to date is limited due to the inclusion of largely Caucasian, middle-income families in the samples.

Many cancer centers in the United States provide psychosocial support services for the over 200,000 women newly diagnosed with breast cancer each year. There are few supportive care services however that target the coping of their adolescent daughters with the stress of their mother's breast cancer. Before developing these services we need to understand more about which coping strategies can mediate the stress of mothers' breast cancer and be included in any interventions. With the increased risk that these daughters face of acquiring breast cancer, developing fear about health screening, and potentially facing life-long depression, it is imperative to understand more about the coping strategies and factors that can mediate the stressfulness of this event. This cross-sectional, correlational study will target 90 adolescent daughters and their mothers with breast cancer recruited through the New York University Medical Cancer Center (NYUMC) and Bellevue Hospital/New York City Health and Hospitals Corporation (NYCHHC) cancer clinics. A contribution of this study to the research to date includes an active outreach to include the minority population. Data collection will include data sheets for mother and daughter demographic information and history, and instruments that target adolescent daughters, the different coping strategies they use, and their level of adjustment or distress with the maternal disease within the first year following diagnosis. Ultimately, the knowledge gained from this study will lead to the development of interventions that target coping and promote adjustment in this vulnerable group.

Conditions
Breast Cancer
Being tested
questionnaires
Keywords
adolescent coping strategies, stress response, breast cancer
Medical subject headings
Breast Neoplasms, Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnairesOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adolescent coping strategies and relationship to the stress response

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

Secondary outcomes (2)
  1. adolescent coping strategies by age

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

  2. adolescent strategies by quality of maternal-adolescent relationship

    Measured: not more than one year past her diagnosis and treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Why it stopped: due to slow accrual and lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933088
Sponsor's protocol ID
NYU 08-072
Status last verified
Jun 2016
First submitted
2 Jul 2009
Last updated
24 Jun 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by NYU Langone Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: due to slow accrual and lack of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adolescent coping strategies and relationship to the stress response (time frame: not more than one year past mother's diagnosis and treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.

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