Parents of Children With CancerNCT01702922
Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)
An observational study of Parents of Children With Cancer and Parents of Children With NF1, run by National Cancer Institute (NCI) at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parents of Children With Cancer, Parents of Children With NF1, Parents of Children With Neurofibromatosis Type I
- How many people
- 262 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Sep 2012to 7 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.@@@@@@
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Canada1 site
Alberta's Children's Hospital Hematology/Oncology/Transplant Program
Alberta, T2L 2A6
About this study
Official title: Understanding the Perceived Influence of Childhood Cancer and NF1 on the Parents' Marital/Partner Relationship: A Descriptive Study
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.
Read more
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.
Read the detailed description
Background:
- Parents face numerous stressors when their child is diagnosed with cancer or NF1, each of which can strain a marriage/partnership.
- Marital/partner 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 and/or 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 relationship/partnership 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 and/or strengthened.
- To compare the perceptions of various subgroups in the sample, (e.g. 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 divorce/separation occurred with a previous partner during/after 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 relationship/partnership.
- 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Dyadic coping
To explore whether positive dyadic coping (joint decision making, joint problem solving, sharing responsibilities) is perceived to have strengthened the marital relationship/partnership since the child s diagnosis with cancer or NF1.
Measured: 3 months
Stressful timepoints
To describe the time points and events during the child s illness trajectory when the relationship becomes most stressed and/or strengthened.
Measured: 3 months
Perception comparison
To compare the perceptions of various subgroups in the sample, (e.g. 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study start13 Sep 2012
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parents of Children With CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lori Wiener, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702922
- Sponsor's protocol ID
- 120206
- Other IDs
- 12-C-0206
- Status last verified
- Jul 2024
- First submitted
- 6 Oct 2012
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Perceived Influence of Childhood Cancer and NF1 on the Parents' Marital/Partner Relationship: A Descriptive Study
- ClinicalTrials.gov ID
- NCT01702922
- Acronym / sponsor ID
- 120206
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 13 Sep 2012 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Parents face numerous stressors when their child is diagnosed with cancer or NF1, each of which can strain a marriage/partnership.
- Marital/partner 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 and/or 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 relationship/partnership 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 and/or strengthened.
- To compare the perceptions of various subgroups in the sample, (e.g. 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 divorce/separation occurred with a previous partner during/after 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 relationship/partnership.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.@@@@@@
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stress impact communication
Time frame: 3 months
To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners.
3 secondary outcomes
Dyadic coping
Time frame: 3 months
Stressful timepoints
Time frame: 3 months
Perception comparison
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Parents of Children With Cancer
RecruitingPhase 3
Influence of Art Workshops and Cognitive Support for Families of Children With Cancer.
Psychologic Resilience
Recruiting
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Neurofibromatosis 1, Noonan Syndrome
Not yet recruiting
Cognitive Intervention for Children and Adolescents With NF1
Neurofibromatosis 1 (NF1), Executive Function (Cognition)
Not yet recruiting
Effect of Progressive Muscle Relaxation on Parental Anxiety
Parent, Anxiety
Active, not recruitingObservational study
Parental Decision-Making for Children With Relapsed Neuroblastoma
Relapsed Neuroblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Wiener, Ph.D. principal investigator
National Cancer Institute (NCI)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parents of Children With Cancer and Parents of Children With NF1, run by National Cancer Institute (NCI) at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress impact communication (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.