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

July 2, 2020 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Counselling
short-term counselling for families
Behavioral: 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.
No Intervention: Wait-list control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks (change between baseline and week 6)
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.
6 weeks (change between baseline and week 6)
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.
6 weeks (change between baseline and week 6)
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.
6 weeks (change between baseline and week 6)
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.
6 weeks (change between baseline and week 6)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Through study completion, an average of 2 years
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
Time Frame: Through study completion, an average of 2 years
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
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.
Through study completion, an average of 2 years
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.
Measures assessed after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
propatient Forschungsstiftung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PP-16-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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