Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)

NCT01702922 | Completed

• 2 other identifiers: 12020612-C-0206
• Study Type: observational
• Target: 262
• Locations: 2 countries
• Sites: 3

Brief Summary

Background: \- Serious illnesses like cancer or Neurofibromatosis Type 1 (NF1), can cause high levels of stress in a family. When a child is diagnosed with cancer or NF1, parents face numerous stressors, each of which can strain relationships. Many parents struggle to effectively cope with the changes in parenting roles that often accompany treatment of childhood cancer or NF1. How parents cope with this stress can influence whether the relationship is strengthened or weakened. Stress levels can also affect the care of the child who has cancer or NF1. Researchers want to better understand the critical time points and events during the child s treatment when the relationship becomes most stressed and/or strengthened. Objectives: \- To study how stress affects the relationship between parents who have a child with cancer or Neurofibromatosis Type 1 (NF1). Eligibility:

• Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer or NF1.
• Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1. At least one of the parents must be a biological or legal parent of the child. Design:
• Participants will fill out a questionnaire either online or by paper and pencil. It will take about 20 minutes to complete. The questions ask about the experience of dealing with a child s cancer OR NF1 diagnosis and how it affects participants relationship with their spouse/partner.
• Some participants will also have an in-depth interview. It will last about an hour. It will ask further questions about the cancer OR NF1 diagnosis and treatment and its effect on the relationship.
• Treatment will not be provided as part of this study.

Conditions

Parents of Children With Cancer; Parents of Children With NF1; Parents of Children With Neurofibromatosis Type I

Keywords

Stress; Marriage; Dyadic Coping; Mother; Father; Natural History

Outcome Measures

Primary Outcomes (1)

• Stress impact communication

  To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners.

  3 months

Secondary Outcomes (3)

• Dyadic coping

  3 months

• Stressful timepoints

  3 months

• Perception comparison

  3 months

Study Arms (3)

1/Active Cancer Parents

Must have been in a partnership at the time child was diagnosed with cancer \& must have been diagnosed at least 3 months prior to enrollment on this study \& be currently receiving treatment

2/Complete Cancer Parents

Must have been in a partnership at the time the child was diagnosed with cancer and the child has completed treatment at age 21 or younger (without evidence of disease) within the previous 3 years

3/NF1 Parents

Must have been in a partnership at the time the child was diagnosed with NF1 and the child must have been diagnosed with NF1 at least 3 months prior to enrollment on this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants must have been in a partnership at the time the child was diagnosed with cancer or NFl. At least one participant must be the biological/legal parent of the child; the partner may or may not be a biological/legal parent. Divorced parents who separated or divorced during or after the child's treatment can participate in this study.@@@@@@

You may qualify if:

• Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1. At least one participant must be the biological/legal parent of the child; the partner may or may not be a biological/legal parent. Divorced parents who separated or divorced during or after the child s treatment can participate in this study.
• The participant s child must be between 1-24 years of age.
• Participants must be 18 years of age or older.
• Participants must be fluent in the English language.
• The participant s child must have been:
• diagnosed with cancer at least 3 months prior to enrollment on this study and be currently receiving treatment OR
• have completed treatment at age 21 or younger (without evidence of disease) within the previous 3 years OR
• diagnosed with NF1 at least 3 months prior to enrollment on this study
• Participants must verbalize willingness to discuss the impact of their child s cancer or NF1 diagnosis on their relationship.
• Able to understand and willing to sign the informed consent document.

You may not qualify if:

• Parents of a child with cancer OR NF1 without a partner/spouse during the child s treatment for cancer or NF1 are excluded from this study.
• Parents who were not living with the child during his or her treatment and involved in the child s care.
• Parents of children who are enrolled in hospice care.
• Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator would compromise the participants ability to engage in the study procedures or results.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Alberta's Children's Hospital Hematology/Oncology/Transplant Program

Alberta, T2L 2A6, Canada

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Lori Wiener, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2012
• First Posted: October 10, 2012
• Study Start: September 13, 2012
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CA (1); US (2)