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| Name | Class |
|---|---|
| propatient Forschungsstiftung | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counselling | Experimental | short-term counselling for families |
|
| Wait-list control group | No Intervention | Wait-list control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-term Counselling for Families | Behavioral | Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Urech, Dr. phil. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Randomized wait-list control design (cross-over).
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| 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 |