Psychological AdjustmentNCT03097458
Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families
A study testing Short-term Counselling for Families in people with Psychological Adjustment and Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Adjustment, Cancer
- What is being tested?
- Short-term Counselling for Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Feb 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The diagnosis is more than 1 year ago
- Diagnosed patients (parent) not living with their children
- Diagnosed patients without custody of their children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Short-term Counselling for Families
- Keywords
- Counselling for Families, Parental cancer, Psychological distress and adjustment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term Counselling for FamiliesBehavioural
Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Counselling | Experimental | short-term counselling for families Receives: Behavioral: Short-term Counselling for Families |
| Wait-list control group | No intervention | Wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks (change between baseline and week 6)
Secondary outcomes (5)
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.
Measured: 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
Collecting sociodemographic characteristics of the population willing to participate with the sociodemographic questionnaire
Measured: 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
Measured: 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.
Measured: 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.
Measured: Measures assessed after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start4 Feb 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological AdjustmentStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized wait-list control design (cross-over).
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- propatient Forschungsstiftung
- Responsible party
- Sponsor
- Investigators
- Corinne Urech, Dr. phil., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097458
- Sponsor's protocol ID
- PP-16-07
- Status last verified
- Jul 2020
- First submitted
- 10 Mar 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families. A Randomized, Wait-list Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT03097458
- Acronym / sponsor ID
- PP-16-07
- Conditions
- Psychological Adjustment, Cancer
- Keywords
- Counselling for Families, Parental cancer, Psychological distress and adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- propatient Forschungsstiftung
- Study start
- 4 Feb 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized wait-list control design (cross-over).
| Arm | Type | Receives |
|---|---|---|
| Counselling | Experimental | Behavioral: Short-term Counselling for Familiesshort-term counselling for families |
| Wait-list control group | No intervention | –Wait-list control group |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- The diagnosis is more than 1 year ago
- Diagnosed patients (parent) not living with their children
- Diagnosed patients without custody of their children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-term Counselling for FamiliesCounselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist. | Behavioural | Counselling |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
Number of participants willing to participate in the counselling
Time frame: 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
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
Dropout rate during the recruitment and intervention procedure
Time frame: Through study completion, an average of 2 years
Client satisfaction on the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Measures assessed after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Urech, Dr. phil. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-term Counselling for Families in people with Psychological Adjustment and Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.