The Representational approach as described in the detailed description.

The Representational approach as described in the detailed description. Each participating parent receives three rounds that consist of two meetings. Each round starts with a meeting where the parent identifies an area where he/she needs more information. The nurse and the parent jointly survey the parent's representation of the area and discusses consequences of knowledge gaps or misunderstandings. Then, new information is introduced and benefits from the new information is discussed. After some days, a follow-up meeting takes place.

Representational approach

Ulla Hällgren Graneheim, Associate professor

The aim of this study is to explore whether an intensified informational intervention built upon the Representational approach framework can reduce stress in parents of children with cancer.

BACKGROUND

Parents of children with cancer have great information needs and report that these are not always met. Psychosocial suffering such as stress and anxiety is also common in this group.

HYPOTHESIS

An informational intervention emanating from the needs identified by parents is associated to decreased perceived stress, decreased depressive symptoms, decreased anxiety, increased satisfaction with information and decreased use of health care contacts in parents.

INTERVENTION

The intervention builds upon the Representational approach. This approach emanates from Leventhal's theories of illness representations and theories of conceptual change. Central qualities in the approach is that parents identify the area where information is needed themselves and that a thorough assessment of their current representation of that area is performed before information is given.

Each participating parent receives three rounds that consist of two meetings. Each round starts with a meeting where the parent identifies an area where he/she needs more information. The nurse and the parent jointly survey the parent's representation of the area and discusses consequences of knowledge gaps or misunderstandings. Then, new information is introduced and benefits from the new information is discussed. After some days, a follow-up meeting takes place.

DESIGN AND METHODS

The intervention will be evaluated using a single-case design (A-B-A-B-A-B-A) with 10 parents. All parents will receive the intervention, and repeated measures of the outcome variables both before and after will be used to assess the effect of the intervention. Data will be collected by web questionnaires with SMS- and e-mail reminders.

In parallel, a process evaluation aiming at describing treatment fidelity, experiences of participation and impact of contextual factors on the results. For this aim, qualitative interviews with participants and audio recording of intervention sessions will be used.

Information to Parents of Children With Cancer. An Exploratory Study

As measured by the Perceived stress scale (PSS). 10 items answered on a 5-point Likert scale.

Includes headache, sleep disturbances, palpitations, and heartburn, each measured on a 4-point scale.

Measured on a 7-point visual digital scale.

Includes general satisfaction with the information from the health care professionals as well as information from the intervention nurses. Measured on a 7-point visual digital scale.

Number of contacts with the health care system concerning the ill child and the parent's own health problems.

Umeå University

Associate professor

Subjects in the intervention group will participate in an eight-session resilience promotion program.

Treatment as usual for subjects in the control group.

Resilience Promotion Program consists of eight sessions. Except the first orientation session and the last review session, other six sessions focus on cultivating the five internal resiliency factors (physical, behavioral, cognitive, emotional and spiritual). There are two sessions for behavioral factor, including one special to deal with the relationships between parents and children.

Resilience promotion program

Yuan Hui Luo, PhD

Cancer is a leading cause of death for children. With the increasing incidence of childhood cancer, the mental health problems emerge in those parents struggle with their children's life-threatened disease. Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Many studies have been conducted to screen the psychological distress for these parents and found a considerable percentage of them suffering from depressive symptoms. Poorer quality of life was also found in parents of children with cancer when compared to parents of children without cancer. Additionally, parental distress interacted with children's emotions and could have detrimental effects on children's both physical and mental health. Therefore, it is important to take measures improving the mental health for parents of children with cancer.

Although current various psychological interventions illustrated small to moderate improvements of mental health for parents of children with cancer, the total effect base on a systematic review was not statistically significant. The purpose of these interventions was predominantly to treat negative mental health problems such as depression and no recognized effective psychological interventions were available for parents of children with cancer until now. Along with the paradigm shift from problem-oriented approach to nurturing strengths in the post-modern period, instead of exclusively treating mental health problems, researchers payed more attention to positive therapy such as resilience promotion program. Resilience usually refers to the ability to adapt adverse conditions and maintain positive status. Resilience studies are mounting since the flourishing of positive psychology movement and meaningful results were gained from corresponding intervention program concentrating on resilience promotion in adolescent education, handling chronic disease and recovery of breast cancer. However, there is a lack of targeted resilience promotion program for parents of children with cancer. The results of our pilot study showed low levels of resilience in parents of children with cancer and strong associations among parental resilience, quality of life and depression. It indicates that the increase in resilience can benefit for the mental health of parents. Therefore, a resilience promotion program will be conducted to examine efficacy for parents of children with cancer.

A Resilience Promotion Program for Parents of Children With Cancer

The primary outcome measure is the resilience of subjects at 6-month follow-up when compare to baseline. The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.

The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.

The Short Form of Medical Outcomes will be used to measure quality of life. The total score ranges from 0.32 for the worst health state to 1 for full health.

Self-rating depression scale will be used to measure depression. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.

Self-rating anxiety scale will be used to measure anxiety. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.

The perceived stress scale will be used to measure stress. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.

The University of Hong Kong

Ho Cheung William Li, PhD

This study is to describe the psychosocial well-being and quality of life of Hong Kong Chinese parents of children with cancer with the aim at understanding the needs and concerns of parents, including their perceptions, behaviour, attitudes, and experiences related to cancer and its treatment of their child.

Advances in diagnostic techniques and cancer treatments have yielded remarkable increases in the overall survival rates of children with cancer. Inevitably, however, cancer and its treatments may also have long-term effects on the physical and psychological well-being of children with cancer,

Previous studies revealed that parents play a pivotal role in encouraging their child with cancer to engage in healthy behaviours. It was shown that Chinese parental psychological behaviour and control may influence the psychological well-being of their children. Therefore, a thorough understanding the needs and concerns of Chinese parents, including their perceptions, behaviour, attitudes, and experiences related to the illness of their child is essential to facilitate them to empower their child to fight at every step of the long and difficult cancer journey.

On the other hand, the diagnosis of cancer not only undermines children themselves in physical and psychological, but also it brings overwhelming psychological distress for these children's parents. An increasing number of studies have examined patients' resilience in adaptation to cancer. Assessing resilience in parents of children with cancer is crucial for a thorough understanding of their responses to stress and adversity, which is an essential prerequisite for the design of an appropriate psychological intervention to enhance their resilience and foster the development of their coping mechanisms and positive psychological well-being. Nevertheless, the resilience levels and its influencing factors among parents of children with cancer in Hong Kong have never been studied.. Further qualitative and quantitative analyses are necessary to thoroughly explore the relationships between resilience and its influencing factors from a culturally specific perspective, with the goal of developing interventions to promote resilience that are applicable to the Hong Kong Chinese population.

A sequential mixed methods design will be used with a quantitative study (Phase I) will be first conducted and followed by a qualitative study (Phase II). The reason for that the quantitative findings will provide a general understanding of the psychosocial well-being and quality of life of Hong Kong Chinese parents of children with cancer. The qualitative findings and the analysis will help to explain the quantitative findings by exploring the perceptions, behaviour, attitudes, and experiences related to cancer and its treatment of their child.

Enhancing the Resilience of Parents by Understanding Their Perceptions, Behaviour, Attitudes, and Experiences Related to Cancer and Its Treatment of Their Child

Connor-Davidson resilience scale (CD-RISC) will be used to measure the resilience level of parents having children with cancer. It contains a total of 25 items, which can be divided into 3 subcategories: (1) tenacity, (2) strength, and (3) optimism.The total possible scores of the scale range from 0 to 100, with a higher score indicating greater resilience.

The EuroQoL 5-Dimension 5-level (EQ-5D-5L) will be used to measure parents' quality of life.Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items, which was originally designed to measure depressive symptoms in general population surveys.Subjects are asked to rate the frequency of each symptom during the past week on a four-point Likert scale representing 'rarely (less than 1 day)', 'some (1-2 days)', 'occasionally (3-4 days)' and 'most (5-7 days)', which are scored from 0 to 3, with total possible scores ranging from 0 to 60. Higher scores indicate a greater risk of depression.

The state anxiety level of parents will be measured by using the The Chinese version of the State Anxiety Scale for Adults (C-SAS-A). The scale consists of 20 items, which are scored from 1 to 4, with possible scores ranging from 20 to 80.

The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree) measuring three sources of support, namely, Family, Friends, and Significant Other.

Parents will be asked their perceptions, behaviour, attitudes, and experiences related to the cancer and its treatment of their child in the semi-structured interview.

Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

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

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

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.

Lori Wiener, Ph.D.

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.

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

Understanding the Perceived Influence of Childhood Cancer and NF1 on the Parents' Marital/Partner Relationship: A Descriptive Study

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 since the child s diagnosis with cancer or NF1.

To describe the time points and events during the child s illness trajectory when the 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Information to Parents of Children With Cancer. An Exploratory Study	NCT01502189	Stress Health Knowledg...	Representationa...	18 Years -	Umeå University
A Resilience Promotion Program for Parents of Children With Cancer	NCT04038242	Parents of Chil...	Resilience prom...	-	The University of Hong Kong
Information to Parents of Children With Cancer. An Exploratory Study	NCT01502189	Stress Health Knowledg...	Representationa...	18 Years -	Umeå University
Enhancing the Resilience of Parents by Understanding Their Perceptions, Behaviour, Attitudes, and Experiences Related to Cancer and Its Treatment of Their Child	NCT04210011	Parents of Chil...		-	The University of Hong Kong
Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)	NCT01702922	Parents of Chil... Parents of Chil... Parents of Chil...		18 Years -	National Institutes of Health Clinical Center (CC)
Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)	NCT01702922	Parents of Chil... Parents of Chil... Parents of Chil...		18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for parents of children with cancer