CancerNCT02399956
Lactation Outcomes Among Survivors of Pediatric Cancer
An observational study of Cancer and Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Survey
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females who are childhood cancer survivors and have reported at least one live birth after cancer diagnosis and treatment.
Who may be able to join
- Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital.
- Female
- 18 years of age or older
- At least one reported live birth after childhood cancer diagnosis and treatment.
Who cannot join
- Unable to read and write.
- Unable to read and understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Childhood cancer treatments are known to cause late effects that frequently involve the endocrine system. Because normal lactation is dependent upon interplay of multiple endocrine factors, the investigators anticipate more breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies, thyroid disorders and obesity. In order to more fully inform clinicians and female survivors, the study of the burden of lactation failure is needed to begin to address the impact of pediatric cancer therapy on lactation success/failure and to examine the association of specific endocrine disorders on lactation outcomes.
Read the detailed description
Participants will complete a cross-sectional survey. Responses will be compared with a national sample of healthy women from Project First (Infant Feeding Practices Survey II).
Primary Objective:
- To describe breastfeeding outcomes (intention, initiation, duration, and weaning) among female SJLIFE protocol participants 18 years of age and older who reported a live birth.
Secondary Objective:
- To compare breastfeeding outcomes between childhood cancer survivors and healthy mothers.
- Being tested
- Survey
- Keywords
- Lactation, Pediatric malignancies, Cancer survivor
- Medical subject headings
- Neoplasms, Leukemia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Also called Questionnaire
Those who agree to participate will complete a cross-sectional survey on lactation outcomes (LACOUT). Eligible participants who consent to our study will complete the LACOUT questionnaire. The questionnaire uses the same breastfeeding measures as the CDC's Project First surveys and adds 21 items that are specific to the participant's cancer treatment and current health status.
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Participants will be recruited from the St. Jude Lifetime Cohort (SJLIFE protocol) and the After Completion of Therapy (ACT) Clinic at St. Jude Children's Research Hospital.
Intervention: Survey Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of survivors who experience successful breastfeeding outcome by age at diagnosis
Measured: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by years since diagnosis
Years since diagnosis will equal the years since diagnosis prior to first pregnancy resulting in a live birth.
Measured: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by therapy with radiation
Measured: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by therapy with surgery
Includes chest and/or brain surgery.
Measured: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of growth hormone deficiency
Growth hormone deficiency indicated by low IGF-1
Measured: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of hypothyroidism
Hypothyroidism, primary or central, measured by TSH level.
Measured: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus
Measured: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity
Obesity (BMI) prior to pregnancy.
Measured: Once, at enrollment (Day 1)
Secondary outcomes (1)
Number of survivors who experience successful breastfeeding outcome compared to healthy women
Breastfeeding outcomes (intention, initiation, and duration/weaning) will be determined by self-report, and dichotomized for analysis. Intention is defined as a mother's specific plan to breastfeed her infant prior to birth (yes/no); initiation is defined as ever having started breastfeeding (yes/no); duration is defined as at least 6 months of breastfeeding (yes/no); and weaning is defined as breastfeeding cessation after 1 year (yes/no).
Data from survivors will be compared with a national sample of healthy women (n=2,000) who responded to the Project First survey (2009). The Infant Feeding Practices Survey II (Project First) is a longitudinal study developed by the Food and Drug Administration and the Centers for Disease Control and Prevention.
Measured: Once, at enrollment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Cox, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399956
- Sponsor's protocol ID
- LACOUT
- Status last verified
- Dec 2015
- First submitted
- 23 Mar 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogg S, Klosky JL, Chemaitilly W, Srivastava DK, Wang M, Carney G, Ojha R, Robison LL, Cox CL, Hudson MM. Breastfeeding practices among childhood cancer survivors. J Cancer Surviv. 2020 Aug;14(4):586-599. doi: 10.1007/s11764-020-00882-y. Epub 2020 Apr 14.
PubMed 32291564
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactation Outcomes Among Survivors of Pediatric Cancer
- ClinicalTrials.gov ID
- NCT02399956
- Acronym / sponsor ID
- LACOUT
- Keywords
- Lactation, Pediatric malignancies, Cancer survivor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Mar 2015 (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.
While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Childhood cancer treatments are known to cause late effects that frequently involve the endocrine system. Because normal lactation is dependent upon interplay of multiple endocrine factors, the investigators anticipate more breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies, thyroid disorders and obesity. In order to more fully inform clinicians and female survivors, the study of the burden of lactation failure is needed to begin to address the impact of pediatric cancer therapy on lactation success/failure and to examine the association of specific endocrine disorders on lactation outcomes.
Detailed description
Participants will complete a cross-sectional survey. Responses will be compared with a national sample of healthy women from Project First (Infant Feeding Practices Survey II).
Primary Objective:
- To describe breastfeeding outcomes (intention, initiation, duration, and weaning) among female SJLIFE protocol participants 18 years of age and older who reported a live birth.
Secondary Objective:
- To compare breastfeeding outcomes between childhood cancer survivors and healthy mothers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: SurveyParticipants will be recruited from the St. Jude Lifetime Cohort (SJLIFE protocol) and the After Completion of Therapy (ACT) Clinic at St. Jude Children's Research Hospital. Intervention: Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females who are childhood cancer survivors and have reported at least one live birth after cancer diagnosis and treatment.
Key inclusion criteria (4 listed)
- Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital.
- Female
- 18 years of age or older
- At least one reported live birth after childhood cancer diagnosis and treatment.
Key exclusion criteria (2 listed)
- Unable to read and write.
- Unable to read and understand English.
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 |
|---|---|---|
| SurveyAlso: QuestionnaireThose who agree to participate will complete a cross-sectional survey on lactation outcomes (LACOUT). Eligible participants who consent to our study will complete the LACOUT questionnaire. The questionnaire uses the same breastfeeding measures as the CDC's Project First surveys and adds 21 items that are specific to the participant's cancer treatment and current health status. | Other | Survivors |
Primary outcome
Number of survivors who experience successful breastfeeding outcome by age at diagnosis
Time frame: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by years since diagnosis
Time frame: Once, at enrollment (Day 1)
Years since diagnosis will equal the years since diagnosis prior to first pregnancy resulting in a live birth.
Number of survivors who experience successful breastfeeding outcome by therapy with radiation
Time frame: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by therapy with surgery
Time frame: Once, at enrollment (Day 1)
Includes chest and/or brain surgery.
Number of survivors who experience successful breastfeeding outcome by diagnosis of growth hormone deficiency
Time frame: Once, at enrollment (Day 1)
Growth hormone deficiency indicated by low IGF-1
Number of survivors who experience successful breastfeeding outcome by diagnosis of hypothyroidism
Time frame: Once, at enrollment (Day 1)
Hypothyroidism, primary or central, measured by TSH level.
Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus
Time frame: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity
Time frame: Once, at enrollment (Day 1)
Obesity (BMI) prior to pregnancy.
1 secondary outcome
Number of survivors who experience successful breastfeeding outcome compared to healthy women
Time frame: Once, at enrollment (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Derived from this study: PubMed 32291564Ogg S, Klosky JL, Chemaitilly W, Srivastava DK, Wang M, Carney G, Ojha R, Robison LL, Cox CL, Hudson MM. Breastfeeding practices among childhood cancer survivors. J Cancer Surviv. 2020 Aug;14(4):586-599. doi: 10.1007/s11764-020-00882-y. Epub 2020 Apr 14.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Cheryl Cox, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Leukemia, run by St. Jude Children's Research Hospital at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of survivors who experience successful breastfeeding outcome by age at diagnosis (time frame: Once, at enrollment (Day 1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399956, which also lists 1 linked publication.
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 10 Dec 2015.