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

NCT ID: NCT03097458

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-04
• Study Completion Date: 2019-09-01

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.

Conditions

Psychological Adjustment; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Counselling

short-term counselling for families

Group Type: EXPERIMENTAL

Short-term Counselling for Families

Intervention Type: BEHAVIORAL

Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.

Wait-list control group

Wait-list control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

propatient Forschungsstiftung

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne Urech, Dr. phil.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

PP-16-07

Identifier Type: -

Identifier Source: org_study_id