Parental Support Intervention in the Oncological Context
Condition: Parent-Child Relations; Parenting; Communication Programs
Study type: Interventional

Summary: 
      Background:

      Cancer has a significant short and long-term impact on the family. Children of cancer
      patients may suffer from emotional, behavioral or somatic difficulties. Following the cancer
      diagnosis, many parents report being concerned about the impact of the illness on their
      children and how to communicate about the illness. In addition, they feel less able to meet
      the needs of their children and have difficulties regulating their emotions in response to
      their children's reactions.

      Methods:

      A randomized controlled trial was designed to assess the efficacy of a parental guidance
      intervention centered on communication with children in the context of a parental cancer.

      This psychological intervention is designed to help parents and significant caregivers of the
      children. The participants are randomly assigned to either an intervention group
      (experimental group) or a waiting list group (control group).

      The participants fill out self reported questionnaires that assess the parental self-efficacy
      in communication, mutual social support, communicational behaviors' with children, parenting
      concerns,communicational difficulties with children, knowledges about communication with
      children in oncological context, socio-demographical status, medical situation, psychiatric
      history, social difficulties and emotional state of the participants and children. The
      semi-structured interview with participants assesses their day to day communication with the
      children and the difficulties related to this communication. Those questionnaires are
      completed at baseline and post treatment (experimental group) and 9 weeks after baseline
      (control group).

      This parental guidance consists of a weekly 4-session intervention. The aim of the sessions
      are to provide child support in the oncological context, mainly through communication.

      Discussion:

      This parental guidance would lead to improvements in knowledge, communication, parental
      self-efficacy and emotional regulation associated with child support.
    

Detailed description: 
      Introduction :

      Parents raise many questions about the impact of the cancer on their children and on the
      communication with them about the disease. For many of them, the cancer impact their parental
      self-efficacy. This decrease of self-efficacy is related to difficulties to communicate
      openly with children and to regulate emotions in response to the feelings, reactions and
      questions of their children. In the same way, some parents report a lack of knowledge on how
      to support their children. They express doubts concerning the way they speak about cancer
      with their children.

      Objectives of the study :

      The primary objective of this study is to test the contribution and effectiveness of a
      psychological intervention in relation to the delivery of an informational booklet regarding
      participants' communication with the child in the oncology context. This intervention should
      increase participants' sense of communicative competence and communicationnal behaviors with
      children.

      The secondary objectives is to evaluate the improvement of the participants' regarding the
      knowledge of how to support a child facing a parent's cancer, the emotional regulating
      capacity associated with participants' communication with the child, the evolution of the
      participants' concerns about the child. When the intervention is carried out in a dyad, it
      should also improve mutual support between participants.

      This intervention is designed to help parents and significant caregivers of the children. It
      is focused on child support in the oncological context, and mainly on the communication
      between parents and their children. This intervention consists in a brief psychological
      intervention focused on improving knowledge, communication, parental self-efficacy and
      emotional regulation associated with child support. The intervention will be customized and
      tailored to each family.

      Participants :

      All significant caregivers of a child aged between 3 and 18 and who's facing parental cancer
      can be included in the study. A significant caregiver is a person who takes care of children
      at a practical, educational and emotional level (mostly parents, step parents, legal
      guardians, grandparents…). The whole study (assessment procedure and psychological
      intervention) is realized with one or two persons involved in child support. A consent form
      will be completed and signed by the adult participants.

      Study design :

      The effectiveness of the parental support intervention is assessed through a longitudinal two
      arms, randomized controlled trial. The psychological intervention is proposed to the main
      caregivers of children confronted to parental cancer.

      In the experimental condition, the two significant caregivers of the child or the individual
      caregiver receive the intervention composed of an informational booklet and a psychological
      intervention. The intervention consists of four sessions, centered on supporting the child in
      the context of parental cancer mainly through communication.

      In the control condition, the participants receive the informational booklet before being
      registered in a waiting list for the psychological intervention. The intervention should
      ideally last two months. Assessments are conducted at two periods (T1 and T2) : before and
      after the intervention for the experimental group and at 9 weeks of interval for the control
      group. The evaluation of the intervention is conducted through questionnaires completed by
      participants and a semi-structured interview.

      Intervention :

      The intervention consists in a brief psychological intervention including four sessions,
      centered on supporting the children in the context of parental cancer through communication.
      The content of the intervention is adapted to the specific situation of each family, their
      difficulties and their needs.

      The first session is dedicated to the assessment of how participants communicate with their
      children about the disease and to take stock of their questions and difficulties. In this
      session, the family situation and the medical context are also discussed and the parental
      skills are identified. The other sessions are essentially focused on the identification of
      children's reactions and needs in the context of cancer and on the communication with
      children about the disease. Practical situation are analyzed and worked through role play
      centered on communicational difficulties. Participants must actively participate in the
      intervention. Specific techniques will be used with the participants to "co-construct"
      personalized communication with their child and to support its implementation. This active
      participation aims to enhance communicational self-efficacy and mutual support among
      participants. During the intervention, emotional regulation strategies are also transmitted
      to the participants through relaxation exercises in order to cope with the emotions felt in
      these particular contexts. A relaxation booklet is given to the participants to practice at
      home the relaxation exercises learned during the sessions. Moreover, all participants
      (experimental and control conditions) receive an informational booklet containing
      age-appropriate recommendations on communication with children about cancer. This booklet
      aims to improve knowledge of participants on how to support their children.

      Assessment procedure :

      Assessments are conducted at two periods (T1 and T2) and consist of questionnaires and a
      semi-structured interview with each participant. For the assessment, participants must refer
      specifically to only one child in their circle, aged between 3 and 18 years. If several
      children meet these criteria, participants determine the one for whom they have the most
      questions regarding communication with him/her about the illness. The child thus identified
      serves as a reference for T1 and T2 in order to standardize the evaluation procedure as much
      as possible.

      Some questionnaires assess the primary outcome of the study : parental self-efficacy in
      communication, communicational behaviors' with children. Other questionnaires assess the
      secondary outcome of the study: Emotional regulation, mutual support between participants,
      communicationnal difficulties with children, parenting concerns, knowledges about
      communication with children in oncological context. Many questionnaires are specifically
      created by the investigator's team. Other questionnaires assess control variables: the
      socio-demographical status, medical situation, psychiatric history, social difficulties and
      emotional state of the participants and children. The semi-structured interview with
      participants assesses their day to day communication with the children and the difficulties
      related to this communication. Each semi-structured interview takes approximatively 20
      minutes and is recorded and transcribed.

      The sample size has been calculated a priori in order to detect the differences in the
      evolution of the two groups (experimental and control conditions) between T1 and T2.

      The sample size calculation was done with the software G*Power. The power analysis has been
      based on a previous pilot study assessing the efficacy of the intervention on patient.
      Self-efficacy score have been considered to perform the power analysis (Change over time in
      Experimental Group: Delta T2-T1 Mean = 0.9514; SD = 0.8043; Change over time Control Group is
      consider as zero). The effect size was 1.183 for a power of 0.90 in two-side. Based on this
      result but considering the small sample of the pilot study, the sample size calculation has
      been based on a 0.9% power, an effect-size of 0.9 and a two-sided α = 0.05 t-test.
      Considering this power analysis, 54 evaluable patients are therefore needed for the efficacy
      assessment. Considering a drop-out rate of approximately 10%, 6 patients should be moreover
      recruited. The aim of the study is therefore to recruit 60 patients.
    

Intervention name(s): Parental guidance
Intervention type(s): Behavioral
Intervention description(s): A psychological intervention including 4 sessions to assess how participants communicate with their children about the disease and take stock of their questions and difficulties. To identify children's reactions and needs. Practical situation are analyzed and worked through role play centered on communicational difficulties to enhance communicational self-efficacy and mutual support among participants. Emotional regulation strategies are learned through relaxation exercises. A relaxation booklet is given to the participants to practice at home too. Moreover, all participants receive an informational booklet containing age-appropriate recommendations on communication with children about cancer.
Other intervention name(s): Efficacy of a parenting cancer related intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The effectiveness of the parental support intervention is assessed through a longitudinal two arms, randomized controlled trial and the experimental condition, the two significant caregivers of the children or the individual caregiver receive the intervention composed of an informational booklet and a psychological intervention. In the control condition, the participants receive the informational booklet before being registered in a waiting list for the psychological intervention. The intervention should ideally last two months. Assessments are conducted at two periods : before and after the intervention for the experimental group and at 9 weeks of interval for the control group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: parental cancer; parental guidance; parent-child communication