Parental Support Intervention in the Oncological Context

NCT03905278 | Completed DMC

• 1 other identifier: CE2681
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parent-Child Relations; Parenting; Communication Programs

Keywords

parental cancer; parental guidance; parent-child communication

Outcome Measures

Primary Outcomes (2)

• Change of the parental self-efficacy in communication

  Assessment through a self-reported scale created for the study and completed by the participants named "Sense of communicational competence with the child". The questionnaire is composed of 16 items. The scale represents the level of certainty regarding the proposed items. The questionnaire has a 10 points Likert scale. The scale ranges is from 0 to 10. 0 means " not at all certain " and 10 "quite certain". Change in the parental self-efficacy in communication is assessed by comparing the questionnaire completed in T1 with the one completed in T2. Parental self-efficacy is also analyzed through a content analysis of the responses given by the participants in the semi-structured interview. The presence of words such as confident, capable or opposite will provide insight into the sense of parental self-efficacy. Comparing the responses in T1 with those in T2 will highlight the change of parental self-efficacy through the increase or decrease in the occurrence of a word.

  8-9 weeks

• Change of the communicational behavior

  Assessment through a content analysis of the responses given by the participants in the semi-directive interview. The main domains explore by the semi directive interview are: description of the communication, feelings during the communication and communicational behaviors. Comparing the responses in T1 with those in T2 will highlight the evolution of the communicational behaviors with the child.

  8-9 weeks

Secondary Outcomes (6)

• Evaluation of the Emotional distress

  8-9 weeks

• Evaluation of the Communicationnal difficulties with the child

  8-9 weeks

• Description of the Communicationnal difficulties with the child

  8-9 weeks

• Evaluation of the mutual support between participants

  8-9 weeks

• Evaluation of parenting concerns

  8-9 weeks

Study Arms (2)

Parental guidance

EXPERIMENTAL

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 principally through communication. Assessments are conducted at two periods : before and after the intervention.

Behavioral: Parental guidance

Waiting List group

NO 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 9 weeks of interval.

Interventions

Parental guidance BEHAVIORAL

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.

Also known as: Efficacy of a parenting cancer related intervention

Parental guidance

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Significant caregiver of a child aged between 3 and 18 who's facing parental cancer
• Participants must be of legal age
• Participants must not have an acute psychiatric or neurological disorder
• Participants must have sufficient command of French (speaking, writing, reading)
• Completing a written informed consent

You may not qualify if:

• Pre-terminal or terminal stage of cancer of the parent
• Death of the parent

Sponsors & Collaborators

• Aurore Liénard: lead
• Centre de Psycho-Oncologie (CPO): collaborator
• Erasme University Hospital: collaborator
• Jules Bordet Institute: collaborator
• Université Libre de Bruxelles: collaborator

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Related Publications (16)

• Rauch PK, Muriel AC. The importance of parenting concerns among patients with cancer. Crit Rev Oncol Hematol. 2004 Jan;49(1):37-42. doi: 10.1016/s1040-8428(03)00095-7.

  PMID: 14734153 BACKGROUND

• Cessna JM, Pidala J, Jacobsen PB. Relationships between parenting self-efficacy and distress in parents who have school-aged children and have been treated with hematopoietic stem cell transplant or have no cancer history. Psychooncology. 2016 Mar;25(3):339-46. doi: 10.1002/pon.3848. Epub 2015 May 12.

  PMID: 25967755 RESULT

• Ellis SJ, Wakefield CE, Antill G, Burns M, Patterson P. Supporting children facing a parent's cancer diagnosis: a systematic review of children's psychosocial needs and existing interventions. Eur J Cancer Care (Engl). 2017 Jan;26(1). doi: 10.1111/ecc.12432. Epub 2016 Jan 18.

  PMID: 26776913 RESULT

• Huizinga GA, Visser A, Zelders-Steyn YE, Teule JA, Reijneveld SA, Roodbol PF. Psychological impact of having a parent with cancer. Eur J Cancer. 2011 Sep;47 Suppl 3:S239-46. doi: 10.1016/S0959-8049(11)70170-8. No abstract available.

  PMID: 21943981 RESULT

• Inhestern L, Haller AC, Wlodarczyk O, Bergelt C. Psychosocial Interventions for Families with Parental Cancer and Barriers and Facilitators to Implementation and Use - A Systematic Review. PLoS One. 2016 Jun 8;11(6):e0156967. doi: 10.1371/journal.pone.0156967. eCollection 2016.

  PMID: 27276079 RESULT

• Koopman HM, Baars RM, Chaplin J, Zwinderman KH. Illness through the eyes of the child: the development of children's understanding of the causes of illness. Patient Educ Couns. 2004 Dec;55(3):363-70. doi: 10.1016/j.pec.2004.02.020.

  PMID: 15582342 RESULT

• Kuhl PK. Early language acquisition: cracking the speech code. Nat Rev Neurosci. 2004 Nov;5(11):831-43. doi: 10.1038/nrn1533.

  PMID: 15496861 RESULT

• Lewis FM, Brandt PA, Cochrane BB, Griffith KA, Grant M, Haase JE, Houldin AD, Post-White J, Zahlis EH, Shands ME. The Enhancing Connections Program: a six-state randomized clinical trial of a cancer parenting program. J Consult Clin Psychol. 2015 Feb;83(1):12-23. doi: 10.1037/a0038219. Epub 2014 Nov 17.

  PMID: 25403016 RESULT

• Merckaert I, Libert Y, Lieutenant F, Moucheux A, Farvacques C, Slachmuylder JL, Razavi D. Desire for formal psychological support among caregivers of patients with cancer: prevalence and implications for screening their needs. Psychooncology. 2013 Jun;22(6):1389-95. doi: 10.1002/pon.3153. Epub 2012 Aug 8.

  PMID: 22888079 RESULT

• Merckaert I, Libert Y, Messin S, Milani M, Slachmuylder JL, Razavi D. Cancer patients' desire for psychological support: prevalence and implications for screening patients' psychological needs. Psychooncology. 2010 Feb;19(2):141-9. doi: 10.1002/pon.1568.

  PMID: 19382112 RESULT

• Moore CW, Rauch PK, Baer L, Pirl WF, Muriel AC. Parenting changes in adults with cancer. Cancer. 2015 Oct 1;121(19):3551-7. doi: 10.1002/cncr.29525. Epub 2015 Jun 19.

  PMID: 26094587 RESULT

• Muriel AC, Moore CW, Baer L, Park ER, Kornblith AB, Pirl W, Prigerson H, Ing J, Rauch PK. Measuring psychosocial distress and parenting concerns among adults with cancer: the Parenting Concerns Questionnaire. Cancer. 2012 Nov 15;118(22):5671-8. doi: 10.1002/cncr.27572. Epub 2012 Apr 19.

  PMID: 22517236 RESULT

• Niemela M, Paananen R, Hakko H, Merikukka M, Gissler M, Rasanen S. The prevalence of children affected by parental cancer and their use of specialized psychiatric services: the 1987 Finnish Birth Cohort study. Int J Cancer. 2012 Nov 1;131(9):2117-25. doi: 10.1002/ijc.27466. Epub 2012 Mar 22.

  PMID: 22307957 RESULT

• Paradis M, Consoli SM, Pelicier N, Lucas V, Andrieu JM, Jian R. [Psychosocial distress and communication about cancer in ill partners and their spouses]. Encephale. 2009 Apr;35(2):146-51. doi: 10.1016/j.encep.2008.02.008. Epub 2008 Jun 13. French.

  PMID: 19393383 RESULT

• Semple CJ, McCaughan E. Family life when a parent is diagnosed with cancer: impact of a psychosocial intervention for young children. Eur J Cancer Care (Engl). 2013 Mar;22(2):219-31. doi: 10.1111/ecc.12018. Epub 2012 Dec 12.

  PMID: 23231498 RESULT

• Syse A, Aas GB, Loge JH. Children and young adults with parents with cancer: a population-based study. Clin Epidemiol. 2012;4:41-52. doi: 10.2147/CLEP.S28984. Epub 2012 Mar 13.

  PMID: 22442635 RESULT

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Razavi

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Aurore Lienard, Coordinator of the Psycho-Oncology Clinic at the Bordet Institute

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: April 5, 2019
• Study Start: September 8, 2017
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)