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NCT Number: NCT03097458

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

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.

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Key information

Conditions

Psychological Adjustment Cancer Neoplasms

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change of children's quality of life on the health-related quality of life questionnaire (KINDL)

    Time frame: 6 weeks (change between baseline and week 6)

    Enhancement of children's quality of life from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  2. Change of children's behavioral-emotional functioning on the Strengths and Difficulties Questionnaire (SDQ)

    Time frame: 6 weeks (change between baseline and week 6)

    Enhancement of children's behavioral-emotional functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  3. Change of parent's mental health on the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6 weeks (change between baseline and week 6)

    Enhancement of parent's mental health from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  4. Change of family functioning on the Family Adaptability and Cohesion Evaluation Scale (FACES IV)

    Time frame: 6 weeks (change between baseline and week 6)

    Enhancement of family functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  5. Change of relationship quality on the relationship questionnaire (Partnerschaftsfragebogen PFB)

    Time frame: 6 weeks (change between baseline and week 6)

    Enhancement of relationship quality from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

Secondary outcomes

  1. Number of participants willing to participate in the counselling

    Time frame: Through study completion, an average of 2 years

    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.

  2. Sociodemographic characteristics (i.e. age, gender, education) of the participants willing to participate in the counselling with the sociodemographic questionnaire

    Time frame: Through study completion, an average of 2 years

    Collecting sociodemographic characteristics of the population willing to participate with the sociodemographic questionnaire

  3. Medical history characteristics (i.e. cancer diagnosis, cancer treatment) of the participants willing to participate in the counselling with the medical history questionnaire

    Time frame: Through study completion, an average of 2 years

    Collecting medical history of the population willing to participate with the medical history questionnaire

  4. Dropout rate during the recruitment and intervention procedure

    Time frame: Through study completion, an average of 2 years

    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.

  5. Client satisfaction on the Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Measures assessed after 6 weeks

    German Version of the Client Satisfaction Questionnaire: Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8) will be used to measure client's intervention satisfaction.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • propatient Forschungsstiftung

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2017
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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