<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702922</url>
  </required_header>
  <id_info>
    <org_study_id>120206</org_study_id>
    <secondary_id>12-C-0206</secondary_id>
    <nct_id>NCT01702922</nct_id>
  </id_info>
  <brief_title>Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)</brief_title>
  <official_title>Understanding the Perceived Influence of Childhood Cancer and NF1 on the Parents' Marital/Partner Relationship: A Descriptive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Serious illnesses like cancer or Neurofibromatosis Type 1 (NF1), can cause high levels of&#xD;
      stress in a family. When a child is diagnosed with cancer or NF1, parents face numerous&#xD;
      stressors, each of which can strain relationships. Many parents struggle to effectively cope&#xD;
      with the changes in parenting roles that often accompany treatment of childhood cancer or&#xD;
      NF1. How parents cope with this stress can influence whether the relationship is strengthened&#xD;
      or weakened. Stress levels can also affect the care of the child who has cancer or NF1.&#xD;
      Researchers want to better understand the critical time points and events during the child s&#xD;
      treatment when the relationship becomes most stressed and/or strengthened.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To study how stress affects the relationship between parents who have a child with cancer&#xD;
      or Neurofibromatosis Type 1 (NF1).&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer or&#xD;
           NF1.&#xD;
&#xD;
        -  Participants must have been in a partnership at the time the child was diagnosed with&#xD;
           cancer or NF1. At least one of the parents must be a biological or legal parent of the&#xD;
           child.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will fill out a questionnaire either online or by paper and pencil. It will&#xD;
           take about 20 minutes to complete. The questions ask about the experience of dealing&#xD;
           with a child s cancer OR NF1 diagnosis and how it affects participants relationship with&#xD;
           their spouse/partner.&#xD;
&#xD;
        -  Some participants will also have an in-depth interview. It will last about an hour. It&#xD;
           will ask further questions about the cancer OR NF1 diagnosis and treatment and its&#xD;
           effect on the relationship.&#xD;
&#xD;
        -  Treatment will not be provided as part of this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  Parents face numerous stressors when their child is diagnosed with cancer or NF1, each&#xD;
           of which can strain a marriage/partnership.&#xD;
&#xD;
        -  Marital/partner relationship dynamics are often not assessed or addressed when providing&#xD;
           health care for children with cancer or NF1. Many parents struggle to effectively cope&#xD;
           with the changes in parenting roles that frequently accompany treatment of childhood&#xD;
           cancer or NF1.&#xD;
&#xD;
        -  How parents cope with these stressors can strengthen or weaken the relationship, and can&#xD;
           impact the entire family, including the care to the child undergoing cancer or NF1&#xD;
           treatments.&#xD;
&#xD;
        -  Limited studies have examined relationship stress or satisfaction during a child s&#xD;
           illness trajectory for cancer or NF1 or the critical time points and events during the&#xD;
           child s illness trajectory when the relationship becomes most stressed and/or&#xD;
           strengthened.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  To explore whether the stress associated with having a child with cancer or NF1 is&#xD;
           perceived to impact the communication between partners.&#xD;
&#xD;
        -  To explore whether positive dyadic coping (joint decision making, joint problem solving,&#xD;
           sharing responsibilities) is perceived to have strengthened the marital&#xD;
           relationship/partnership following the child s diagnosis with cancer or NF1.&#xD;
&#xD;
        -  To describe the time points and events during the child s illness trajectory when the&#xD;
           parents relationship becomes most stressed and/or strengthened.&#xD;
&#xD;
        -  To compare the perceptions of various subgroups in the sample, (e.g. parents who score&#xD;
           either high or low on a marital stress scale, mothers versus fathers) statistically or&#xD;
           qualitatively as the distribution of the characteristics of the sample allow.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Participants must have been in a partnership at the time the child was diagnosed with&#xD;
           cancer or NF1. At least one of the participating parents must be a biological or legal&#xD;
           parent of the child. If a divorce/separation occurred with a previous partner&#xD;
           during/after the child s diagnosis, the other partner will be invited to participate.&#xD;
&#xD;
        -  The participant s child must be between 1-24 years of age.&#xD;
&#xD;
        -  There are 3 groups of participants being recruited: 1) those who have a child who has&#xD;
           been diagnosed with cancer at least 3 months prior to enrolling on this study and are&#xD;
           currently undergoing cancer treatment, 2) those who have completed treatment at age 21&#xD;
           or younger (without evidence of disease) within the previous 3 years, and 3) those who&#xD;
           have a child who has been diagnosed with NF1 at least 3 months prior to enrolling on&#xD;
           this study.&#xD;
&#xD;
        -  Participants must be fluent in the English language&#xD;
&#xD;
        -  The participant s child must have been diagnosed with cancer or NF1 at least 3 months&#xD;
           prior to enrollment on this study.&#xD;
&#xD;
        -  Participants must verbalize willingness to discuss the impact of their child s cancer or&#xD;
           NF1 diagnosis on their relationship.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Cross-sectional, multi-center, exploratory study utilizing a convenience sample to&#xD;
           explore the parents perception of how the child s cancer or NF1 diagnosis, treatment,&#xD;
           decision making and other aspects of care are addressed and impact the martial&#xD;
           relationship/partnership.&#xD;
&#xD;
        -  Subjects will complete a self-administered measure that addresses potential stresses&#xD;
           experienced in the partnership since the child s diagnosis and how each are either&#xD;
           resolved or create a divide in the relationship.&#xD;
&#xD;
        -  Subjects who experience a high or low degree of relationship stress on a standardized&#xD;
           marital stress form (a score greater than one standard deviation from the norm) will be&#xD;
           invited to participate in a qualitative interview, that further explores which&#xD;
           components of parenting a child with cancer is most challenging on the relationship.&#xD;
&#xD;
        -  Up to 360 participants will be enrolled onto this study (up to 180 couples). Subjects&#xD;
           may be offered a gift card ($20 Target gift card at NIH) upon completion of the&#xD;
           questionnaire for their time and inconvenience, where available. Due to limitations with&#xD;
           funding, participants enrolled after July 2016 will not receive a gift card.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2012</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stress impact communication</measure>
    <time_frame>3 months</time_frame>
    <description>To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyadic coping</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stressful timepoints</measure>
    <time_frame>3 months</time_frame>
    <description>To describe the time points and events during the child s illness trajectory when the relationship becomes most stressed and/or strengthened.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception comparison</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">262</enrollment>
  <condition>Parents of Children With Cancer</condition>
  <condition>Parents of Children With NF1</condition>
  <condition>Parents of Children With Neurofibromatosis Type I</condition>
  <arm_group>
    <arm_group_label>1/Active Cancer Parents</arm_group_label>
    <description>Must have been in a partnership at the time child was diagnosed with cancer &amp;amp; must have been diagnosed at least 3 months prior to enrollment on this study &amp;amp; be currently receiving treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2/Complete Cancer Parents</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3/NF1 Parents</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants must have been in a partnership at the time the child was diagnosed with&#xD;
        cancer or NFl. At least one participant must be the biological/legal parent of the child;&#xD;
        the partner may or may not be a biological/legal parent. Divorced parents who separated or&#xD;
        divorced during or after the child's treatment can participate in this study.@@@@@@&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Participants must have been in a partnership at the time the child was diagnosed with&#xD;
             cancer or NF1. At least one participant must be the biological/legal parent of the&#xD;
             child; the partner may or may not be a biological/legal parent. Divorced parents who&#xD;
             separated or divorced during or after the child s treatment can participate in this&#xD;
             study.&#xD;
&#xD;
          -  The participant s child must be between 1-24 years of age.&#xD;
&#xD;
          -  Participants must be 18 years of age or older.&#xD;
&#xD;
          -  Participants must be fluent in the English language.&#xD;
&#xD;
          -  The participant s child must have been:&#xD;
&#xD;
               -  diagnosed with cancer at least 3 months prior to enrollment on this study and be&#xD;
                  currently receiving treatment OR&#xD;
&#xD;
               -  have completed treatment at age 21 or younger (without evidence of disease)&#xD;
                  within the previous 3 years OR&#xD;
&#xD;
               -  diagnosed with NF1 at least 3 months prior to enrollment on this study&#xD;
&#xD;
          -  Participants must verbalize willingness to discuss the impact of their child s cancer&#xD;
             or NF1 diagnosis on their relationship.&#xD;
&#xD;
          -  Able to understand and willing to sign the informed consent document.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Parents of a child with cancer OR NF1 without a partner/spouse during the child s&#xD;
             treatment for cancer or NF1 are excluded from this study.&#xD;
&#xD;
          -  Parents who were not living with the child during his or her treatment and involved in&#xD;
             the child s care.&#xD;
&#xD;
          -  Parents of children who are enrolled in hospice care.&#xD;
&#xD;
          -  Presence of psychotic symptoms or severe psychological distress, which in the judgment&#xD;
             of the Principal or Associate Investigator would compromise the participants ability&#xD;
             to engage in the study procedures or results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Wiener, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2012-C-0206.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>August 22, 2023</verification_date>
  <study_first_submitted>October 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Marriage</keyword>
  <keyword>Dyadic Coping</keyword>
  <keyword>Mother</keyword>
  <keyword>Father</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurofibromatoses</mesh_term>
    <mesh_term>Neurofibromatosis 1</mesh_term>
    <mesh_term>Neurofibroma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702922
org study id: 120206
secondary id: 12-C-0206
nct id: NCT01702922
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Stress impact communication
time frame: 3 months
description: To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners.
measure: Dyadic coping
time frame: 3 months
description: 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.
measure: Stressful timepoints
time frame: 3 months
description: To describe the time points and events during the child s illness trajectory when the relationship becomes most stressed and/or strengthened.
measure: Perception comparison
time frame: 3 months
description: 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.
arm group label: 1/Active Cancer Parents
description: Must have been in a partnership at the time child was diagnosed with cancer &amp; must have been diagnosed at least 3 months prior to enrollment on this study &amp; be currently receiving treatment
arm group label: 2/Complete Cancer Parents
description: 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
arm group label: 3/NF1 Parents
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lori Wiener, Ph.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
country: Canada
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2012-C-0206.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Neurofibromatoses
mesh term: Neurofibromatosis 1
mesh term: Neurofibroma