Lactation Outcomes Among Survivors of Pediatric Cancer

NCT02399956 | Completed

• 1 other identifier: LACOUT
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer; Leukemia

Keywords

Lactation; Pediatric malignancies; Cancer survivor

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

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

  Once, at enrollment (Day 1)

Study Arms (1)

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

Interventions

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.

Also known as: Questionnaire

Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital.
• Female
• years of age or older
• At least one reported live birth after childhood cancer diagnosis and treatment.

You may not qualify if:

• Unable to read and write.
• Unable to read and understand English.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• 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.

  PMID: 32291564 DERIVED

Related Links

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

MeSH Terms

Conditions

Neoplasms; Leukemia; Breast Feeding

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cheryl Cox, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

US (1)