Ignite Creation Date:
2024-05-06 @ 1:00 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01702922
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2012-10-06
Brief Title:
Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 NF1
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Understanding the Perceived Influence of Childhood Cancer and NF1 on the Parents MaritalPartner Relationship A Descriptive Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 spousepartner
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
- 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 andor 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 spousepartner
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
Detailed Description:
Background
Parents face numerous stressors when their child is diagnosed with cancer or NF1 each of which can strain a marriagepartnership
Maritalpartner relationship dynamics are often not assessed or addressed when providing health care for children with cancer or NF1 Many parents struggle to effectively cope with the changes in parenting roles that frequently accompany treatment of childhood cancer or NF1
How parents cope with these stressors can strengthen or weaken the relationship and can impact the entire family including the care to the child undergoing cancer or NF1 treatments
Limited studies have examined relationship stress or satisfaction during a child s illness trajectory for cancer or NF1 or the critical time points and events during the child s illness trajectory when the relationship becomes most stressed andor strengthened
Objectives
To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners
To explore whether positive dyadic coping joint decision making joint problem solving sharing responsibilities is perceived to have strengthened the marital relationshippartnership following the child s diagnosis with cancer or NF1
To describe the time points and events during the child s illness trajectory when the parents relationship becomes most stressed andor strengthened
To compare the perceptions of various subgroups in the sample eg parents who score either high or low on a marital stress scale mothers versus fathers statistically or qualitatively as the distribution of the characteristics of the sample allow
Eligibility
Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1 At least one of the participating parents must be a biological or legal parent of the child If a divorceseparation occurred with a previous partner duringafter the child s diagnosis the other partner will be invited to participate
The participant s child must be between 1-24 years of age
There are 3 groups of participants being recruited 1 those who have a child who has been diagnosed with cancer at least 3 months prior to enrolling on this study and are currently undergoing cancer treatment 2 those who have completed treatment at age 21 or younger without evidence of disease within the previous 3 years and 3 those who have a child who has been diagnosed with NF1 at least 3 months prior to enrolling on this study
Participants must be fluent in the English language
The participant s child must have been diagnosed with cancer or 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
Design
Cross-sectional multi-center exploratory study utilizing a convenience sample to explore the parents perception of how the child s cancer or NF1 diagnosis treatment decision making and other aspects of care are addressed and impact the martial relationshippartnership
Subjects will complete a self-administered measure that addresses potential stresses experienced in the partnership since the child s diagnosis and how each are either resolved or create a divide in the relationship
Subjects who experience a high or low degree of relationship stress on a standardized marital stress form a score greater than one standard deviation from the norm will be invited to participate in a qualitative interview that further explores which components of parenting a child with cancer is most challenging on the relationship
Up to 360 participants will be enrolled onto this study up to 180 couples Subjects may be offered a gift card 20 Target gift card at NIH upon completion of the questionnaire for their time and inconvenience where available Due to limitations with funding participants enrolled after July 2016 will not receive a gift card
Parents face numerous stressors when their child is diagnosed with cancer or NF1 each of which can strain a marriagepartnership
Maritalpartner relationship dynamics are often not assessed or addressed when providing health care for children with cancer or NF1 Many parents struggle to effectively cope with the changes in parenting roles that frequently accompany treatment of childhood cancer or NF1
How parents cope with these stressors can strengthen or weaken the relationship and can impact the entire family including the care to the child undergoing cancer or NF1 treatments
Limited studies have examined relationship stress or satisfaction during a child s illness trajectory for cancer or NF1 or the critical time points and events during the child s illness trajectory when the relationship becomes most stressed andor strengthened
Objectives
To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners
To explore whether positive dyadic coping joint decision making joint problem solving sharing responsibilities is perceived to have strengthened the marital relationshippartnership following the child s diagnosis with cancer or NF1
To describe the time points and events during the child s illness trajectory when the parents relationship becomes most stressed andor strengthened
To compare the perceptions of various subgroups in the sample eg parents who score either high or low on a marital stress scale mothers versus fathers statistically or qualitatively as the distribution of the characteristics of the sample allow
Eligibility
Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1 At least one of the participating parents must be a biological or legal parent of the child If a divorceseparation occurred with a previous partner duringafter the child s diagnosis the other partner will be invited to participate
The participant s child must be between 1-24 years of age
There are 3 groups of participants being recruited 1 those who have a child who has been diagnosed with cancer at least 3 months prior to enrolling on this study and are currently undergoing cancer treatment 2 those who have completed treatment at age 21 or younger without evidence of disease within the previous 3 years and 3 those who have a child who has been diagnosed with NF1 at least 3 months prior to enrolling on this study
Participants must be fluent in the English language
The participant s child must have been diagnosed with cancer or 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
Design
Cross-sectional multi-center exploratory study utilizing a convenience sample to explore the parents perception of how the child s cancer or NF1 diagnosis treatment decision making and other aspects of care are addressed and impact the martial relationshippartnership
Subjects will complete a self-administered measure that addresses potential stresses experienced in the partnership since the child s diagnosis and how each are either resolved or create a divide in the relationship
Subjects who experience a high or low degree of relationship stress on a standardized marital stress form a score greater than one standard deviation from the norm will be invited to participate in a qualitative interview that further explores which components of parenting a child with cancer is most challenging on the relationship
Up to 360 participants will be enrolled onto this study up to 180 couples Subjects may be offered a gift card 20 Target gift card at NIH upon completion of the questionnaire for their time and inconvenience where available Due to limitations with funding participants enrolled after July 2016 will not receive a gift card
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-C-0206 | None | None | None |