Clinical trial NCT03097458: Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families
Official title: Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families. A Randomized, Wait-list Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Adjustment
Cancer
Keywords: Counselling for Families
Parental cancer
Psychological distress and adjustment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: propatient Forschungsstiftung
First posted: 2017-03-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized wait-list control design (cross-over).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of children's quality of life on the health-related quality of life questionnaire (KINDL)
timeFrame: 6 weeks (change between baseline and week 6)
measure: Change of children's behavioral-emotional functioning on the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 6 weeks (change between baseline and week 6)
measure: Change of parent's mental health on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 weeks (change between baseline and week 6)
measure: Change of family functioning on the Family Adaptability and Cohesion Evaluation Scale (FACES IV)
timeFrame: 6 weeks (change between baseline and week 6)
measure: Change of relationship quality on the relationship questionnaire (Partnerschaftsfragebogen PFB)
timeFrame: 6 weeks (change between baseline and week 6)
Secondary outcomes:
measure: Number of participants willing to participate in the counselling
timeFrame: Through study completion, an average of 2 years
measure: Sociodemographic characteristics (i.e. age, gender, education) of the participants willing to participate in the counselling with the sociodemographic questionnaire
timeFrame: Through study completion, an average of 2 years
measure: Medical history characteristics (i.e. cancer diagnosis, cancer treatment) of the participants willing to participate in the counselling with the medical history questionnaire
timeFrame: Through study completion, an average of 2 years
measure: Dropout rate during the recruitment and intervention procedure
timeFrame: Through study completion, an average of 2 years
measure: Client satisfaction on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Measures assessed after 6 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Corinne Urech, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References: