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The Family Talk Intervention in Pediatric Oncology

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ClinicalTrials.gov Identifier: NCT03650530
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Malin Lövgren, Ersta Sköndal University College

Brief Summary:

Even though most children with cancer now survive the ill child has to go through painful treatments which include suffering and uncertainty for all family members. The overall aim is to evaluate a modified version of the Family Talk Intervention (FTI) among families affected by childhood cancer. The goals of FTI are to increase family communication, the family members' resilience, knowledge about the illness, and thereby reduce the family members' long-term psychosocial well-being. Specific aims are to assess the feasibility (Aim 1) and the possible effects of the FTI (Aim 2).

Two to three months after diagnosis families at one of six pediatric oncology units in Sweden will be recruited to FTI. All families at this unit who have a child (with cancer and/or sibling) in the age of 6 to 19 will be asked to participate. The recruitment will continuing for 9 months.

The core elements in the intervention are to support: 1) the families in talking about the illness and related subjects, 2) the parents in understanding the needs of their children and how to support them, and 3) the families in identifying their strengths and how to use them. FTI entails six meetings with two interventionists (with the whole family and with the individual members of the family) at 1-2 weekly intervals.

Questionnaires, interviews and field notes will be used to evaluate the intervention. Time points for data collection: before the intervention starts (baseline), directly after the intervention (follow-up 1) and 6 months after baseline (follow-up 2).

Since few intervention studies (if any) of this kind have been carried out in pediatric oncology in Sweden to date, this study fills a knowledge gap. Research has described how cancer affects the whole family, and the importance of an open and honest communication about the illness in order to reduce the psychological suffering. The interventions presented here are likely to improve communication within the family, which may reduce the risk of long-term psychological distress for all family members.


Condition or disease Intervention/treatment Phase
Pediatric Oncology Other: The Family Talk Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: An intervention study with a single group design.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Family Talk Intervention Among Families With Childhood Cancer
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: The Family Talk Intervention
These families will participate in a psychosocial support program.
Other: The Family Talk Intervention
The family meets two interventionists at six time points.
Other Name: Beardslee's Family Intervention




Primary Outcome Measures :
  1. Survey data on family communication [ Time Frame: Baseline (before the intervention start), follow-up 1 (after the end of the intervention, approximately 2 months after baseline) and follow-up 2 (approximately 6 months after baseline) ]
    Changed family Communication will be measured with the Family Communication Scale. The minimum possible score is 10 points, and the maximum possible score is 50 points. A higher score indicates a better level of family communication. Total score of 10-29 represent very low level of communication, 30-35 low level of communication, 36-39 moderate level of communication, 40-44 high level of communication and 45-50 very high level of communication. A step within the framework of very high/high/moderate/low/very low represents a change. Study-specific questions will also be used.


Secondary Outcome Measures :
  1. Survey data on psychosocial health [ Time Frame: Baseline (before the intervention start), follow-up 1 (after the end of the intervention, approximately 2 months after baseline) and follow-up 2 (approximately 6 months after baseline) ]
    For the children: Changed psychosocial wellbeing using the Pediatric Quality of Life Inventory version 4.0. To create the Psychosocial Health Summary Score, the mean is computed as the sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales. A 4.5 change in PedsQL score for Child self-report has been determined as a minimum Clinical meaningful difference.

  2. Survey data regarding knowledge about the illness [ Time Frame: Baseline (before the intervention start), follow-up 1 (after the end of the intervention, approximately 2 months after baseline) and follow-up 2 (approximately 6 months after baseline) ]
    Changed knowledge about the illness: Study specific questions will be used, for example open-ended questions to children about the namn of the illness, if someone has talked to them about the treatment, the prognosis, etc.

  3. Survey data on family satisfaction [ Time Frame: Baseline (before the intervention start), follow-up 1 (after the end of the intervention, approximately 2 months after baseline) and follow-up 2 (approximately 6 months after baseline) ]
    Changed family satisfaction measured by the Family Satisfaction Scale. The sum of all items represents a total score ranged 10-50. Total score of 10-29 represent very low satisfaction, 30-35 low satisfaction, 36-39 moderate satisfaction, 40-44 high satisfaction and 45-50 very high satisfaction. A step within the framework of very high/high/moderate/low/very low represents a change.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One of the children in the family, the ill child or the sibling(s), have to be between 6-19 years old
  • At least one adult and one child in the age 6-19 from the same family have to participate
  • The family members have to understand and talk Swedish

Exclusion Criteria:

  • Families with children only under 6 years or over 19 years
  • Families were only the parent(s) or the children want to participate
  • Families that do not speak and write Swedish.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650530


Contacts
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Contact: Malin Lövgren, PhD +46733302789 malin.lovgren@ki.se
Contact: Ulrika Kreicbergs, PhD +46766365121 ulrika.kreicbergs@esh.se

Locations
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Sweden
Ersta Sköndal Bräcke University College Recruiting
Stockholm, Sweden, SE- 10061
Contact: Malin Lövgren, PhD    0046733302789    malin.lovgren@esh.se   
Sub-Investigator: Ulrika Kreicbergs, PhD         
Sub-Investigator: Camilla Udo, PhD         
Sponsors and Collaborators
Ersta Sköndal University College
Investigators
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Principal Investigator: Malin Lövgren, PhD Ersta Sköndal Bräcke University College

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Malin Lövgren, Assiciate Professor, Ersta Sköndal University College
ClinicalTrials.gov Identifier: NCT03650530     History of Changes
Other Study ID Numbers: ErstaSUC
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is not planed to be shared with other researchers outside the group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malin Lövgren, Ersta Sköndal University College:
Family-centred intervention
Support program
The Family Talk Intervention
Additional relevant MeSH terms:
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Neoplasms