An interventional study of Psycho-Education and Psycho-Experiential in Metastatic Cancer, Cancer Recurrence and Hematological Cancer, sponsored by Université Libre de Bruxelles. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Supportive care
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.
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Université Libre de Bruxelles is the lead sponsor of 45 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Psycho-Education
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.
Device: Psycho-Education · Behavioral: Psycho-Experiential
Supporting parents by providing useful informations and recommendations regarding communication with their children.
(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).
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.
Time frame: 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: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
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.
Time frame: 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).
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Week 12 (T2).
Communication about cancer or its consequences in the family from the AYA perspective
Communication about cancer or its consequences in the family from the AYA perspective is assessed through 10 items 10-point Likert scale (0 = not at all true; 10 = absolutely true).
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
AYA's communication wishes
AYA communication wishes are assessed through 10 items 10-point Likert scale (0 = not at all true; 10 = absolutely true).
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
AYA's future expectations of parental disease and treatments
AYA's future expectations regarding parental disease and treatments are assessed using a 10-item measure. For each item, participants are asked to (1) choose between two proposed outcomes for a given situation-one optimistic and one pessimistic-and (2) indicate their level of certainty that this outcome will occur, selecting from three options: might, probably, or definitely. Among the 10 situations presented, 6 are neutral and realistic, while 4 are specifically related to the disease. Scoring is based on both the valence of the choice and the level of certainty. If the optimistic outcome is chosen, the score is assigned a positive sign; if the pessimistic outcome is chosen, the score is negative. The level of certainty determines the absolute value of the score: might = 1, probably = 2, and definitely = 3. Scores are summed separately for the two subscales.
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
Participant's future expectations of disease and treatments
This questionnaire should only be completed by the parent if one of his or her children is participating in the study. Participant's future expectations of disease and treatments are assessed using a 10-item measure. For each item, participants are asked to (1) choose between two proposed outcomes for a given situation-one optimistic and one pessimistic - and (2) indicate their level of certainty that this outcome will occur, selecting from three options : might, probably, or definitely. Among the 10 situations presented, 6 are neutral and realistic, while 4 are specifically related to the disease. Scoring is based on both the valence of the choice and the level of certainty. If the optimistic outcome is chosen, the score is assigned a positive sign; if the pessimistic outcome is chosen, the score is negative. The level of certainty determines the absolute value of the score: might = 1, probably = 2, and definitely = 3. Scores are summed separately for the two subscales.
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
AYA's perception of their own global quality of life (KIDSCREEN)
AYA global quality of life is assessed through the KIDSCREEN. The KIDSCREEN is available in a self-reported or hetero-reported version. The AYAs complete the self-reported version. We used 36 items 5-point Likert scale (the positions on the scale change from one item to another). 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) Feelings (3 items), (3) General mood (7 items), (4) 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.
Time frame: Baseline (T1), week 12 (T2) and week 26 (T3).
Plan to share: Undecided
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