Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families

Cancer Clinical Trial

Official title:

Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families. A Randomized, Wait-list Controlled Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097458
• Other study ID #: PP-16-07
• Status: Completed
• Phase: N/A
• Start date: February 4, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: July 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A parental cancer diagnosis challenges the family's stability and the parent-child relationship. It may impact the children's well-being, so that about one third of them develop clinically relevant levels of psychological distress. Psycho-oncological family-based counselling programs have been shown to elevate children's and parents' well-being. However, there is still a dearth of familial health services in Switzerland, which has also been recognized by the Swiss National Cancer Program (2011-2017).

This study aims to implement and evaluate a short-term family counselling intervention at the Cancer Center of the University Hospital Basel. The primary objective of the study is the enhancement of adjustment to the parental cancer diagnosis. The study seeks secondary to determine the feasibility of the short-term counselling Intervention.

Description:

This study ist designed as a randomized controlled wait-list Intervention study, which aims to implement and evaluate a short-term family counselling intervention at the Cancer Center of the University Hospital Basel. The study will be divided into two stages: Stage 1 serves as the preparatory work phase, where the intervention manual will be developed as well as the implementation strategy into the hospital. In stage 2 the intervention will be evaluated, with an interim analysis to test for feasibility. The primary objective of the study is the enhancement of adjustment (family, parents and children) to the parental cancer diagnosis. The study seeks secondary to determine the feasibility of the short-term counselling intervention in the Swiss medical setting and to identify predictors for families with continuing psychosocial adjustment problems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months and older

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature

• Diagnosis of any kind of cancer, inclusive relapse, within the last year with an expected survival of at least 8 months

• Married, cohabiting or single parent

• At least one child between 1-5 - 18 years

• German speaking

Exclusion Criteria:

• The diagnosis is more than 1 year ago

• Diagnosed patients (parent) not living with their children

• Diagnosed patients without custody of their children

Related Conditions & MeSH terms

• Cancer
• Psychological Adjustment

Intervention

Behavioral:
• Short-term Counselling for Families
Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	propatient Forschungsstiftung

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of children's quality of life on the health-related quality of life questionnaire (KINDL)	Enhancement of children's quality of life from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.	6 weeks (change between baseline and week 6)
Primary	Change of children's behavioral-emotional functioning on the Strengths and Difficulties Questionnaire (SDQ)	Enhancement of children's behavioral-emotional functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.	6 weeks (change between baseline and week 6)
Primary	Change of parent's mental health on the Hospital Anxiety and Depression Scale (HADS)	Enhancement of parent's mental health from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.	6 weeks (change between baseline and week 6)
Primary	Change of family functioning on the Family Adaptability and Cohesion Evaluation Scale (FACES IV)	Enhancement of family functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.	6 weeks (change between baseline and week 6)
Primary	Change of relationship quality on the relationship questionnaire (Partnerschaftsfragebogen PFB)	Enhancement of relationship quality from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.	6 weeks (change between baseline and week 6)
Secondary	Number of participants willing to participate in the counselling	Secondary outcome will be to determine whether a short-term counselling intervention is feasible in the Swiss medical setting by collecting the number of participants willing to participate.	Through study completion, an average of 2 years
Secondary	Sociodemographic characteristics (i.e. age, gender, education) of the participants willing to participate in the counselling with the sociodemographic questionnaire	Collecting sociodemographic characteristics of the population willing to participate with the sociodemographic questionnaire	Through study completion, an average of 2 years
Secondary	Medical history characteristics (i.e. cancer diagnosis, cancer treatment) of the participants willing to participate in the counselling with the medical history questionnaire	Collecting medical history of the population willing to participate with the medical history questionnaire	Through study completion, an average of 2 years
Secondary	Dropout rate during the recruitment and intervention procedure	Secondary outcome will be to determine whether a short-term counselling intervention is feasible in the Swiss medical setting by collecting dropout rate during the recruitment and intervention procedure.	Through study completion, an average of 2 years
Secondary	Client satisfaction on the Client Satisfaction Questionnaire (CSQ-8)	German Version of the Client Satisfaction Questionnaire: Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8) will be used to measure client's intervention satisfaction.	Measures assessed after 6 weeks