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Lactation Outcomes Among Survivors of Pediatric Cancer

NCT ID: NCT02399956

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Cancer Leukemia

Keywords

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Lactation Pediatric malignancies Cancer survivor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Survey

Intervention Type OTHER

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.

Interventions

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Survey

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.

Intervention Type OTHER

Other Intervention Names

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Questionnaire

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Unable to read and write.
* Unable to read and understand English.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheryl Cox, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32291564 (View on PubMed)

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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LACOUT

Identifier Type: -

Identifier Source: org_study_id