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NCT Number: NCT02399956

Lactation Outcomes Among Survivors of Pediatric Cancer

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.

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Key information

Conditions

Cancer Behavior Breast Feeding Feeding Behavior Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey

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.

Other names: Questionnaire

Primary outcomes

  1. Number of survivors who experience successful breastfeeding outcome by age at diagnosis

    Time frame: Once, at enrollment (Day 1)

  2. 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.

  3. Number of survivors who experience successful breastfeeding outcome by therapy with radiation

    Time frame: Once, at enrollment (Day 1)

  4. 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.

  5. 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

  6. 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.

  7. Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus

    Time frame: Once, at enrollment (Day 1)

  8. Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity

    Time frame: Once, at enrollment (Day 1)

    Obesity (BMI) prior to pregnancy.

Secondary outcomes

  1. Number of survivors who experience successful breastfeeding outcome compared to healthy women

    Time frame: Once, at enrollment (Day 1)

    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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2015
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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