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.
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
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.
adolescent coping strategies and relationship to the stress response
Measured: not more than one year past mother's diagnosis and treatment
Secondary outcomes (2)
adolescent coping strategies by age
Measured: not more than one year past mother's diagnosis and treatment
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.
- First posted7 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: due to slow accrual and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yelena Novik, MD, Principal investigator, NYU Langone Health
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Daughters' Response and Adjustment to Maternal Breast Cancer
- ClinicalTrials.gov ID
- NCT00933088
- Acronym / sponsor ID
- NYU 08-072
- Conditions
- Breast Cancer
- Keywords
- adolescent coping strategies, stress response, breast cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to slow accrual and lack of funding
- Enrolment
- 43 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (10 listed)
- For mothers:
- For daughters:
Key exclusion criteria (8 listed)
- For mothers:
- For daughters:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesThe 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. | Other | – |
Primary outcome
adolescent coping strategies and relationship to the stress response
Time frame: not more than one year past mother's diagnosis and treatment
2 secondary outcomes
adolescent coping strategies by age
Time frame: not more than one year past mother's diagnosis and treatment
adolescent strategies by quality of maternal-adolescent relationship
Time frame: not more than one year past her diagnosis and treatment
Results and safety
The study was stopped early (reason given: due to slow accrual and lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelena Novik, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
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.