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.

Study Overview

• Status: Completed
• Conditions: Leukemia; Cancer
• Intervention / Treatment: Other: Survey

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 Type: Observational
• Enrollment (Actual): 471

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females who are childhood cancer survivors and have reported at least one live birth after cancer diagnosis and treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: 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.; Other Names: Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of survivors who experience successful breastfeeding outcome by age at diagnosis		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.	Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by therapy with radiation		Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by therapy with surgery	Includes chest and/or brain surgery.	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	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.	Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus		Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity	Obesity (BMI) prior to pregnancy.	Once, at enrollment (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once, at enrollment (Day 1)

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Cheryl Cox, PhD, St. Jude Children's Research Hospital

Publications and helpful links

General 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.

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (ESTIMATE): March 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cancer survivor; Lactation; Pediatric malignancies
• Other Study ID Numbers: LACOUT