The Family Talk Intervention in Pediatric Oncology

NCT03650530 | Completed

• 1 other identifier: ErstaSUC
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Oncology

Keywords

Family-centred intervention; Support program; The Family Talk Intervention

Outcome Measures

Primary Outcomes (1)

• Survey data on family communication

  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.

  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)

Secondary Outcomes (3)

• Survey data on psychosocial health

  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)

• Survey data regarding knowledge about the illness

  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)

• Survey data on family satisfaction

  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)

Study Arms (1)

The Family Talk Intervention

EXPERIMENTAL

These families will participate in a psychosocial support program.

Other: The Family Talk Intervention

Interventions

The Family Talk Intervention OTHER

The family meets two interventionists at six time points.

Also known as: Beardslee's Family Intervention

The Family Talk Intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ersta Sköndal University College: lead

Study Sites (1)

Ersta Sköndal Bräcke University College

Stockholm, SE- 10061, Sweden

Location

Related Publications (3)

• Eklund R, Lovgren M. The Family Talk Intervention in Pediatric Oncology: Ill Children's Descriptions of Feasibility and Potential Effects. J Pediatr Hematol Oncol Nurs. 2022 May-Jun;39(3):143-154. doi: 10.1177/27527530221068423. Epub 2022 Feb 17.

  PMID: 35467434 DERIVED

• Iveus K, Eklund R, Kreicbergs U, Lovgren M. Family bonding as a result of the family talk intervention in pediatric oncology: Siblings' experiences. Pediatr Blood Cancer. 2022 Mar;69(3):e29517. doi: 10.1002/pbc.29517. Epub 2021 Dec 31.

  PMID: 34971075 DERIVED

• Lovgren M, Kreicbergs U, Udo C. Family talk intervention in paediatric oncology: a pilot study protocol. BMJ Paediatr Open. 2019 Jan 31;3(1):e000417. doi: 10.1136/bmjpo-2018-000417. eCollection 2019.

  PMID: 30815590 DERIVED

Study Officials

• Malin Lövgren, PhD

  Ersta Sköndal Bräcke University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiciate Professor

Model Details: An intervention study with a single group design.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 28, 2018
• Study Start: September 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)