Metastatic CancerNCT07341815
Parental Support Intervention in an Advanced Oncological Context
A study testing Psycho-Education and Psycho-Experiential in people with Metastatic Cancer and Cancer Recurrence, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
This prospective, two-arm randomized trial compares a psycho-educational program to a psycho-educational and experiential program for parents with advanced cancer. These two interventions aim to support parent-child communication about cancer, but we hypothesize that the combined intervention will be more effective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Cancer Recurrence, Hematological Cancer
- What is being tested?
- Psycho-Education and Psycho-Experiential
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 27 May 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic cancer, recurrence of cancer or certain types of hematological cancer (chronic disease, acute leukemia, multiple myeloma or lymphoma recurrence)
- Have at least one child aged between 10 and 25 years
- Wish to benefit from a psychological intervention about communication with their children about cancer or its consequences
- Able to read and speak French
- Accept to give their written informed consent
Who cannot join
- Severe neurological disorder
- Severe psychiatric disorder
- (Pre-)terminal phase of cancer disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
Aurore Liénard, PhD, +3225417250, aurore.lienard@hubruxelles.be
Isabelle Merckaert, PhD, +3226504880, isabelle.merckaert@ulb.be
About this study
Official title: Efficacy of a Parental Support Intervention to Improve Communication of Advanced Cancer Patients With Adolescents and Young Adults
This prospective, two-arm randomized trial compares a psycho-educational program to a psycho-educational and experiential program for parents with advanced cancer. These two interventions aim to support parent-child communication about cancer, but we hypothesize that the combined intervention will be more effective for all studied communication variables.
Read the detailed description
Background:
A recent review shows that 14-22% of patients with cancer are parents of underaged children or young adults. Following the cancer diagnosis, many parents report being concerned about the impact of the disease on their children and about how to communicate about the disease with them, especially about the uncertainty that is inherent in disease. In addition, they may report a decrease in their parental self-efficacy and in their parental skills to support their children. There are few randomized controlled trials designed to test the efficacy of parenting support interventions in oncology. Moreover, the existing studies use such varied designs and evaluation tools that there is no evidence-based practice in this area to date.
Methods:
The study is a prospective, two-armed randomized trial with two groups receiving either a psycho-educational program or a psycho-educational and experiential program.
This study is offered to patients with advanced cancer who have at least one child aged between 10 and 25 years. All participants must be interested in discussing how to communicate with their children about the disease.
All participants complete a baseline assessment (T1). Then, they are assigned randomly to one of the two intervention groups during a one-hour welcoming session. The second assessment interview (T2) is scheduled two weeks after the end of both interventions. The third assessment interview (T3) takes place 3 months after T2. Finally, a fourth short assessment (T4) is scheduled at the end of the current school year at T2. Moreover, participants are asked to complete a weekly assessment from T1 to T3 (during 6 months).
The "Supporting Open Uncertainty Responses and Communication Engagement : a psycho-educational program" (SOURCE - educational) and the "Supporting Open Uncertainty Responses and Communication Engagement : a psycho-educational and experiential program" (SOURCE - experiential) are based on an informational booklet designed to improve the knowledge of how to communicate with children, adolescents and young adults (AYAs), with a particular focus on communicating about the uncertainty inherent in disease. Both interventions are conducted in 5 to 6 manualized sessions by the same experienced psycho-oncologist.
In the "SOURCE - experiential", sessions last about 1,5 hour and are held in person or by teleconsultation. This intervention is based on support of parental self-efficacy and exercises about parental competence to communicate with their AYAs (role play and support of transfer in daily life).
In the "SOURCE - educational", sessions last about 15 minutes and are held by teleconsultation. It is a psycho-educational intervention aimed at supporting parents by providing information and recommendations regarding communication with AYAs and the potential impact of the disease on them.
Discussion:
It is hypothesized that the parental support provided in the psycho-educational and experiential program will be more effective than sessions offered in the context of the psycho-educational program for all the studied variables, even on communicating about uncertainty, a subject we know to be more sensitive.
EXPLORATORY PART OF THE STUDY Participants are also informed that, if they agree, their children aged between 10 and 25 will be invited to participate to an exploratory part of the study. To be eligible to participate in this exploratory part, AYAs must have a strong command of French, and be aware that their parent has a disease (whether or not called "cancer") and that their parent receive or has received a treatment for that disease. AYAs are excluded if they are living completely independently, if they have severe neurological or psychiatric disorders, or if they are in special-needs education. In order to participate, AYAs must sign a consent document. If they are minors, an additional consent document must be signed by their ill parent, and the co-parent must give an oral consent.A non-participation of the AYA to the study does not affect the inclusion of their parent in the study.
Exploratory outcomes are: (1) communication about cancer or its consequences in the family from the AYA's perspective, (2) AYA's communication wishes, (3) future expectations of parental disease and treatments and (4) global quality of life. Questionnaires are completed three times, at most 48 hours apart from the T1, T2, and T3 of their parent.
- Conditions
- Metastatic Cancer, Cancer Recurrence, Hematological Cancer, Parent-Child Relations, Parenting, Communication
- Being tested
- Psycho-Education, Psycho-Experiential
- Keywords
- Parental cancer, Parent-child communication, Parenting intervention, Advanced cancer, Adolescent Young Adult (AYA), Uncertainty
- Medical subject headings
- Neoplasm Metastasis, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-EducationDevice
Supporting parents by providing useful informations and recommendations regarding communication with their children.
Psycho-ExperientialBehavioural
(1) Continuous support of parental self-efficacy about parental competence to communicate ; (2) Exercises about improving parental competence to communicate with their children (role-plays, transfer in the daily life).
| Study group | Role | What they receive |
|---|---|---|
| SOURCE - educational | Active comparator | Participants receive an informational brochure created for the study and take part in five or six intervention sessions lasting around 15 minutes each. These sessions focus on the informational content of the brochure, which is summarized in a PowerPoint presentation presented by the psycho-oncologist. Receives: Device: Psycho-Education |
| SOURCE - experiential | Experimental | Participants receive the same informational brochure and benefit from the same summary presentation in PowerPoint format as in the other arm. In addition, there is an experiential component, meaning that participants raise their specific questions/concerns related to the topics and work on them in a practical way with the psycho- oncologist. Receives: Device: Psycho-Education; Behavioral: Psycho-Experiential |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of parental communication with their children about cancer or its consequences
In the weekly assessment, participants are asked how many moments of communication they had with their child(ren) about cancer, treatments, or their consequences during the past week. This item measures the frequency of communication.
Measured: Weeks 2 to 26 (weekly assessment).
Quality of parental communication with their children about cancer or its consequences
A composite communication quality score will be computed for each communication moment reported in the weekly assessments. The score will be based on several dimensions:
- Initiative, indicating whether the communication was initiated by the parent (yes/no);
- Duration of the communication moment, reported in minutes;
- Parental self-efficacy, defined as the perceived ability to inform, listen, answer questions, and reassure, each rated on a 0-10 Likert scale (0 = not at all capable; 10 = completely capable);
- Comfort during the communication, assessed separately for the parent and the child using a 0-10 Likert scale (0 = not at all comfortable; 10 = extremely comfortable);
- Disease-related topics discussed (yes/no);
- Emotional expression, assessed using two yes/no items indicating whether the parent expressed their emotional experience and/or addressed the child's emotional experience related to the disease.
Higher scores reflect better communication quality.
Measured: Weeks 2 to 26 (weekly assessment).
Parental communication difficulties
The level of perceived difficulties to communicate is assessed through one item 10-point Likert scale (0 = not at all certain; 10 = absolutely certain).
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Parental self-efficacy regarding the communication with their children about cancer or its consequences
The level of self-efficacy to communicate is assessed through 27 items covering a list of disease-related communication topics (3 subscales of 9 items each : "I know how to communicate", "I am able to communicate" and "I am comfortable to communicate") 10-point Likert scale (0 = not at all certain; 10 = absolutely certain).
The total score is obtained by summing the responses to all 27 items (maximum score = 270), and subscale scores are calculated by summing the 9 corresponding items (maximum score = 90).
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Participants' communication behaviors
The participants' communication behaviors about cancer are assessed through a 13 items 4- point Likert scale (0 = no; 1 = rather no; 2 = rather yes; 3 = yes).
Items are phrased as statements such as "I talked about…" and cover a range of disease-related topics. A total score of disease-related communication repertoire is calculated by summing the responses to all items, with higher scores indicating a broader range of topics addressed.
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Theoretical knowledge about the cancer-related concerns of children of different ages
The level of theoretical knowledge about children's concerns about cancer is assessed through a true-false questionnaire containing 12 items.
Correct answers were previously determined by experts in the field. Each correct response is scored as 1 point, and each incorrect response as 0 point. A total knowledge score is obtained by summing the scores across all items, with higher scores reflecting greater theoretical knowledge.
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Under- / Over- communication
Over- and under-communication are assessed using 10 items, divided into two subscales of 5 items each, rated on a 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). Each subscale score ranges from 0 to 50.
For the total score, the under-communication subscale is assigned negative values and the over-communication subscale positive values; the two are then summed, resulting in a possible range from -50 to +50. Higher positive scores indicate a stronger tendency toward over-communication, whereas lower (negative) scores indicate a stronger tendency toward under-communication about cancer.
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Parental perception of their children's experience of cancer
The parental perception of their children's experience of cancer is assessed through 8 items rated on a 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). A higher item score indicates that the parent feels they have a good understanding of their children's experience regarding the disease-related topic.
The total score, which can range from 0 to 80, reflects the parent's overall perception of their children's experience of the disease.
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Secondary outcomes (7)
Perceived children's communication behaviors
Perceived children's communication behaviors are assessed through a 12-item, 4-point Likert scale (0 = no; 1 = rather no; 2 = rather yes; 3 = yes). This questionnaire explores disease-related topics the child spontaneously brought up during conversations. The total score, obtained by summing the responses to all items, reflects the breadth of the child's spontaneous communication repertoire regarding the disease.
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Parental self-efficacy in general
The level of parental self-efficacy in general is assessed through one validated item (Moore et al., 2015) rated on a 10-point Likert scale (0 = not at all certain; 10 = absolutely certain).
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Children's academic performance
The authors developed a questionnaire to assess the academic performance of participants' children. This questionnaire explores the child's current level of education (i.e., current school grade if the child is still enrolled), as well as retrospective information about the previous school year, including the jury's decision (pass with or without conditions, or failure), the child's overall grade point average, and the number of subjects in which the child failed. Additionally, the questionnaire collects information on the total number of grade retentions since the beginning of the child's schooling.
Measured: Baseline (T1), at the end of the current academic year at the time of week 12 (T4).
Participant's perception of their AYA's global quality of life (KIDSCREEN)
Children's global quality of life is assessed using the KIDSCREEN questionnaire. The KIDSCREEN is available in both self-reported and hetero-reported versions; the latter is used to gather parents' perspectives on their children's quality of life. We used a 36-item version, rated on a 5-point Likert scale (with response options varying across items).
In addition to a total score-calculated by summing responses across all 36 items-the questionnaire provides results on seven subscales: (1) Physical activities and health (5 items), (2) Child's feelings (3 items), (3) General mood (7 items), (4) Child's free time (4 items), (5) At home (6 items), (6) Friends (5 items), and (7) At school/university (6 items). For the last subscale, a "not applicable" option is available if the child is no longer enrolled in school.
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Parents' Distress associated with parenting
Parenting concerns related to cancer are assessed through the PCQ (Parenting Concerns Questionnaire). This questionnaire contains 14 items 5-point Likert scale (1 = not at all concerned; 5 = extremely concerned). The subscales of the PCQ are: "practical impact of illness on child", "emotional impact of illness on child" and "concerns about coparent". However, the third PCQ subscale has been adapted to measure concerns in relation to the entourage as a whole.
Measured: Baseline (T1), week 12 (T2) and week 26 (T3).
Expectations and Benefits of the intervention
The BENEVAL is a tool used in T1 to assess participants' expectations of the intervention and in T2 to assess participants' perceived benefits (Razavi, Wauthia, Bodart, \& Servais, 2014). It contains 11 domains, each with sub-questions (between 2 and 9 sub-questions) to be answered on a 5-point Lickert scale (from not at all to very much).
Measured: Baseline (T1), week 12 (T2).
Perceived usefulness of the interventions
Perceived usefulness of the interventions is assessed using a 10-item, 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). A total score is calculated by summing the responses across all items.
Measured: Week 12 (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start27 May 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-armed randomized trial with two groups receiving different interventions. In the "SOURCE - educational", patients benefit from a psycho-educational intervention based on an informational booklet. In the "SOURCE - experiential", the patients benefit from an intervention composed of a psycho-educational part (based on the same informational booklet) and a psycho-experiential intervention (role playing, relaxation exercises, etc.).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Psycho-Oncologie (CPO), Jules Bordet Institute, Erasme University Hospital, Fonds Thierry Maricq & Véronique Detournay, Fondation Roi Baudouin, Belgium, Association Jules Bordet
- Responsible party
- Principal investigator, Aurore Liénard, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341815
- Sponsor's protocol ID
- CE3373
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Parental Support Intervention to Improve Communication of Advanced Cancer Patients With Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT07341815
- Acronym / sponsor ID
- CE3373
- Conditions
- Metastatic Cancer, Cancer Recurrence, Hematological Cancer, Parent-Child Relations, Parenting, Communication
- Keywords
- Parental cancer, Parent-child communication, Parenting intervention, Advanced cancer, Adolescent Young Adult (AYA), Uncertainty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Collaborators
- Centre de Psycho-Oncologie (CPO), Jules Bordet Institute, Erasme University Hospital, Fonds Thierry Maricq & Véronique Detournay, Fondation Roi Baudouin, Belgium, Association Jules Bordet
- Study start
- 27 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jan 2026 (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.
This prospective, two-arm randomized trial compares a psycho-educational program to a psycho-educational and experiential program for parents with advanced cancer. These two interventions aim to support parent-child communication about cancer, but we hypothesize that the combined intervention will be more effective for all studied communication variables.
Detailed description
Background:
A recent review shows that 14-22% of patients with cancer are parents of underaged children or young adults. Following the cancer diagnosis, many parents report being concerned about the impact of the disease on their children and about how to communicate about the disease with them, especially about the uncertainty that is inherent in disease. In addition, they may report a decrease in their parental self-efficacy and in their parental skills to support their children. There are few randomized controlled trials designed to test the efficacy of parenting support interventions in oncology. Moreover, the existing studies use such varied designs and evaluation tools that there is no evidence-based practice in this area to date.
Methods:
The study is a prospective, two-armed randomized trial with two groups receiving either a psycho-educational program or a psycho-educational and experiential program.
This study is offered to patients with advanced cancer who have at least one child aged between 10 and 25 years. All participants must be interested in discussing how to communicate with their children about the disease.
All participants complete a baseline assessment (T1). Then, they are assigned randomly to one of the two intervention groups during a one-hour welcoming session. The second assessment interview (T2) is scheduled two weeks after the end of both interventions. The third assessment interview (T3) takes place 3 months after T2. Finally, a fourth short assessment (T4) is scheduled at the end of the current school year at T2. Moreover, participants are asked to complete a weekly assessment from T1 to T3 (during 6 months).
The "Supporting Open Uncertainty Responses and Communication Engagement : a psycho-educational program" (SOURCE - educational) and the "Supporting Open Uncertainty Responses and Communication Engagement : a psycho-educational and experiential program" (SOURCE - experiential) are based on an informational booklet designed to improve the knowledge of how to communicate with children, adolescents and young adults (AYAs), with a particular focus on communicating about the uncertainty inherent in disease. Both interventions are conducted in 5 to 6 manualized sessions by the same experienced psycho-oncologist.
In the "SOURCE - experiential", sessions last about 1,5 hour and are held in person or by teleconsultation. This intervention is based on support of parental self-efficacy and exercises about parental competence to communicate with their AYAs (role play and support of transfer in daily life).
In the "SOURCE - educational", sessions last about 15 minutes and are held by teleconsultation. It is a psycho-educational intervention aimed at supporting parents by providing information and recommendations regarding communication with AYAs and the potential impact of the disease on them.
Discussion:
It is hypothesized that the parental support provided in the psycho-educational and experiential program will be more effective than sessions offered in the context of the psycho-educational program for all the studied variables, even on communicating about uncertainty, a subject we know to be more sensitive.
EXPLORATORY PART OF THE STUDY Participants are also informed that, if they agree, their children aged between 10 and 25 will be invited to participate to an exploratory part of the study. To be eligible to participate in this exploratory part, AYAs must have a strong command of French, and be aware that their parent has a disease (whether or not called "cancer") and that their parent receive or has received a treatment for that disease. AYAs are excluded if they are living completely independently, if they have severe neurological or psychiatric disorders, or if they are in special-needs education. In order to participate, AYAs must sign a consent document. If they are minors, an additional consent document must be signed by their ill parent, and the co-parent must give an oral consent.A non-participation of the AYA to the study does not affect the inclusion of their parent in the study.
Exploratory outcomes are: (1) communication about cancer or its consequences in the family from the AYA's perspective, (2) AYA's communication wishes, (3) future expectations of parental disease and treatments and (4) global quality of life. Questionnaires are completed three times, at most 48 hours apart from the T1, T2, and T3 of their parent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a two-armed randomized trial with two groups receiving different interventions. In the "SOURCE - educational", patients benefit from a psycho-educational intervention based on an informational booklet. In the "SOURCE - experiential", the patients benefit from an intervention composed of a psycho-educational part (based on the same informational booklet) and a psycho-experiential intervention (role playing, relaxation exercises, etc.).
| Arm | Type | Receives |
|---|---|---|
| SOURCE - educational | Active comparator | Device: Psycho-EducationParticipants receive an informational brochure created for the study and take part in five or six intervention sessions lasting around 15 minutes each. These sessions focus on the informational content of the brochure, which is summarized in a PowerPoint presentation presented by the psycho-oncologist. |
| SOURCE - experiential | Experimental | Device: Psycho-Education, Behavioral: Psycho-ExperientialParticipants receive the same informational brochure and benefit from the same summary presentation in PowerPoint format as in the other arm. In addition, there is an experiential component, meaning that participants raise their specific questions/concerns related to the topics and work on them in a practical way with the psycho- oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Metastatic cancer, recurrence of cancer or certain types of hematological cancer (chronic disease, acute leukemia, multiple myeloma or lymphoma recurrence)
- Have at least one child aged between 10 and 25 years
- Wish to benefit from a psychological intervention about communication with their children about cancer or its consequences
- Able to read and speak French
- Accept to give their written informed consent
Key exclusion criteria (3 listed)
- Severe neurological disorder
- Severe psychiatric disorder
- (Pre-)terminal phase of cancer disease
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 |
|---|---|---|
| Psycho-EducationSupporting parents by providing useful informations and recommendations regarding communication with their children. | Device | SOURCE - educational, SOURCE - experiential |
| Psycho-Experiential(1) Continuous support of parental self-efficacy about parental competence to communicate ; (2) Exercises about improving parental competence to communicate with their children (role-plays, transfer in the daily life). | Behavioural | SOURCE - experiential |
Primary outcome
Frequency of parental communication with their children about cancer or its consequences
Time frame: Weeks 2 to 26 (weekly assessment).
In the weekly assessment, participants are asked how many moments of communication they had with their child(ren) about cancer, treatments, or their consequences during the past week. This item measures the frequency of communication.
Quality of parental communication with their children about cancer or its consequences
Time frame: Weeks 2 to 26 (weekly assessment).
A composite communication quality score will be computed for each communication moment reported in the weekly assessments. The score will be based on several dimensions: 1. Initiative, indicating whether the communication was initiated by the parent (yes/no); 2. Duration of the communication moment, reported in minutes; 3. Parental self-efficacy, defined as the perceived ability to inform, listen, answer questions, and reassure, each rated on a 0-10 Likert scale (0 = not at all capable; 10 = completely capable); 4. Comfort during the communication, assessed separately for the parent and the child using a 0-10 Likert scale (0 = not at all comfortable; 10 = extremely comfortable); 5. Disease-related topics discussed (yes/no); 6. Emotional expression, assessed using two yes/no items indicating whether the parent expressed their emotional experience and/or addressed the child's emotional experience related to the disease. Higher scores reflect better communication quality.
Parental communication difficulties
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
The level of perceived difficulties to communicate is assessed through one item 10-point Likert scale (0 = not at all certain; 10 = absolutely certain).
Parental self-efficacy regarding the communication with their children about cancer or its consequences
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
The level of self-efficacy to communicate is assessed through 27 items covering a list of disease-related communication topics (3 subscales of 9 items each : "I know how to communicate", "I am able to communicate" and "I am comfortable to communicate") 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). The total score is obtained by summing the responses to all 27 items (maximum score = 270), and subscale scores are calculated by summing the 9 corresponding items (maximum score = 90).
Participants' communication behaviors
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
The participants' communication behaviors about cancer are assessed through a 13 items 4- point Likert scale (0 = no; 1 = rather no; 2 = rather yes; 3 = yes). Items are phrased as statements such as "I talked about…" and cover a range of disease-related topics. A total score of disease-related communication repertoire is calculated by summing the responses to all items, with higher scores indicating a broader range of topics addressed.
Theoretical knowledge about the cancer-related concerns of children of different ages
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
The level of theoretical knowledge about children's concerns about cancer is assessed through a true-false questionnaire containing 12 items. Correct answers were previously determined by experts in the field. Each correct response is scored as 1 point, and each incorrect response as 0 point. A total knowledge score is obtained by summing the scores across all items, with higher scores reflecting greater theoretical knowledge.
Under- / Over- communication
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
Over- and under-communication are assessed using 10 items, divided into two subscales of 5 items each, rated on a 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). Each subscale score ranges from 0 to 50. For the total score, the under-communication subscale is assigned negative values and the over-communication subscale positive values; the two are then summed, resulting in a possible range from -50 to +50. Higher positive scores indicate a stronger tendency toward over-communication, whereas lower (negative) scores indicate a stronger tendency toward under-communication about cancer.
Parental perception of their children's experience of cancer
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
The parental perception of their children's experience of cancer is assessed through 8 items rated on a 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). A higher item score indicates that the parent feels they have a good understanding of their children's experience regarding the disease-related topic. The total score, which can range from 0 to 80, reflects the parent's overall perception of their children's experience of the disease.
7 secondary outcomes
Perceived children's communication behaviors
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
Parental self-efficacy in general
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
Children's academic performance
Time frame: Baseline (T1), at the end of the current academic year at the time of week 12 (T4).
Participant's perception of their AYA's global quality of life (KIDSCREEN)
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
Parents' Distress associated with parenting
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
Expectations and Benefits of the intervention
Time frame: Baseline (T1), week 12 (T2).
Perceived usefulness of the interventions
Time frame: Week 12 (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Cancer
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-Education and Psycho-Experiential in people with Metastatic Cancer and Cancer Recurrence, run by Université Libre de Bruxelles at 1 site in Belgium.
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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore Liénard, PhD (+32 25417250, aurore.lienard@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of parental communication with their children about cancer or its consequences (time frame: Weeks 2 to 26 (weekly assessment).). The study lists 8 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 14 Jan 2026.