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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Psychological Adjustment, Cancer

Intervention / Treatment
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* Behavioral: Short-term Counselling for Families


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized wait-list control design (cross-over).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counselling<br>short-term counselling for families | Behavioral: Short-term Counselling for Families<br>* Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.<br>|
| No Intervention: Wait-list control group<br>Wait-list control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Counselling for Families, Parental cancer, Psychological distress and adjustment