AzTrials
AzTrials

Childhood CancerNCT06854822

Siblings to a Child With Cancer: Needs and Pre-loss Grief

An observational study of Childhood Cancer and Siblings, run by Ersta Sköndal University College at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Background and Aim: Siblings to a brother or sister with cancer have reported difficulties dealing with such things as their parents' suffering, loneliness in relation to their own feelings as well as uncertainty regarding their brother's/sister's treatment, prognosis and survival. Read more about this study

Who is it for?
Ages 12 to 24 years
How many people
200 participants
Where
1 siteSweden
Study dates
1 Nov 2025to 1 Mar 2027
Phase
Observational
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 12 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: All siblings that have a brother or sister with cancer 0-17 years.

Who may be able to join

  • Age: 12-24 years
  • Have a brother or sister with childhood cancer
  • Swedish speaking siblings

Who cannot join

  • -Bereaved siblings

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Malin Lövgren, PhD contact

0733302789

malin.lovgren@mchs.se

Sweden1 site, 1 recruiting
  • Marie Cederschiöld Unicersity College

    Stockholm

    Malin Lövgren, PhD, malin.lovgren@mcsh.se

    Recruiting

Other trials in Sweden

About this study

Official title: Siblings to a Child With Cancer: Psychometric Evaluations of Instruments Assessing Siblings Needs and Pre-loss Grief

Background and Aim: Siblings to a brother or sister with cancer have reported difficulties dealing with such things as their parents' suffering, loneliness in relation to their own feelings as well as uncertainty regarding their brother's/sister's treatment, prognosis and survival. Siblings also struggle with fear of death and dying, and unresolved grief. Unfortunately, siblings are a forgotten group both in society, within the family, in health care, in school, and in research even if there has been a huge improvement the last 10 years. These children's needs must be identified and handled during the illness trajectory as a way of supporting their challenging situation and prevent avoidable psychological distress. Nevertheless, there exists no validated standardized assessment instrument in Swedish that measure the needs of these children even if it is well known that it is beneficial for emotional and psychological well-being to use assessment instrument. Moreover, no instrument in Swedish exists that identify children with prolonged pre-death grief despite that prolonged grief during illness is associated with psychological distress. This study therefore aim to translate, culturally adapt, and evaluate the psychometric properties of the Swedish version of the Sibling Cancer Needs Instrument (SCNI) and Prolonged Grief Disorder (PG-12) among children and youths who have a brother or sister with cancer.

Material and Methods: Present instruments will be translated and culturally adapted according to the World Health Organization's (WHO) guidelines. After that, the psychometric properties of the Swedish version of SCNI and PG-12 will be examined. The Swedish version of the SCNI and PG-12 will be revised by a group of several experts in psychology, paediatric oncology, and family health, for its face and content validity. In addition, pre-test respondents will include approx. 10 siblings. They will be recruited from one of the six pediatric oncology centers in Sweden, the home care for children at the same hospital, and at the hospice for children and youths in Sweden (Lilla Erstagården) where established collaborations with clinicians exists today with sibling supporters. Information about the study will be given by the researchers who also ask for informed consent. Children aged 15 years and older consent themselves while those between 12-14 years have to have consent from their guardian(s)/parent(s). Pre-test respondents will be administered SCNI and PG-12 and be systematically debriefed. During debriefing, siblings will be asked what they thought the question was asking, whether they could repeat the question in their own words, what came to their mind when they heard a particular phrase or term. They will also be asked to explain how they choose their answer. These questions will be repeated for each item. The answers to these questions should be compared to the respondent's actual responses to the instrument for consistency. Respondents will also be asked about any word they did not understand as well as any word or expression that they found unacceptable or offensive. Finally, when alternative words or expressions exist for one item or expression, the pre-test respondent should be asked to choose which of the alternatives conforms better to their usual language. After that, siblings will be asked to participate in a web-survey. They will be recruited from: 1) the six pediatric oncology centers in Sweden, 2) the hospice for children and youths in Sweden (Lilla Erstagården), and 3) via advertisement on social media, e.g. on Instagram at "Nära Cancer" and the Childhood Cancer Fund. The siblings will also be identified by a sibling supporter at the six pediatric oncology centers and Lilla Erstagården. The sibling supporters will invite the siblings to the study by giving them a web address to a website where they will find information about the study. On the website, the siblings could either go directly to the web-survey (if the sibling is 15 years or older) or register their interest to participate in the web-survey (if the sibling is between 12-14 years). Parents of siblings who register their interest to participate in the web-survey on the website (siblings aged 12-14 years), will be contacted by a researcher via email or phone (depending on how they wish to be contacted), and the parents/guardians and the sibling will be informed about the study, and informed consent will be granted from both guardians/parents. Advertisement on social media will take the siblings or parents/guardians to the same web-page/web-survey as previously described.

Analysis: Descriptive statistics will be used to present demographic data and study variables, including means and standard deviations, medians and quartiles, and frequencies. We will use factor analysis in order to evaluate the fit of the models. A sample size of 200 will be acceptable if the models are not too complex.

Medical subject headings
Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychosocial needs

    The Sibling Cancer Need Instrument (SCNI) will be used as primary outcome. SCNI is developed for siblings in the age of 12-24 years. SCNI has 45 items and seven domains: information; practical assistance; "time out" and recreation; feelings; support (friends and other young people); understanding from my family; and sibling relationship. The instrument contains the sentence stem 'I currently need....', and responses use a 4-item response scale where: 1=no need, 2=low need, 3=moderate need, and 4= strong need. The possible range of scores is 45-180, with higher scores indicating more unmet needs.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (1)
  1. Pre-grief

    Prolonged grief disorder (PG12). PG-12 covers: 1) separation distress, which is characterized by manifestations of longing and yearning, 2) emotional, cognitive, and behavioural symptoms, e.g., diminished sense of self, feeling stunned or shocked by the patient's illness, having trouble accepting it, and feelings of meaninglessness, and 3) social and occupational functioning. A summary score for the symptom items is calculated by totaling each individual item score from 1 (not at all) to 5 (overwhelmingly). Symptom scores can range from 10 to 50. A score of 30 or greater indicates higher levels of PGD.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study start1 Nov 2025
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06854822
Sponsor's protocol ID
2023-03752-01
Other IDs
2023
Status last verified
Sep 2025
First submitted
29 Jan 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Cancer and Siblings, run by Ersta Sköndal University College at 1 site in Sweden.

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 3 inclusion and 1 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 21 Sep 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 Sweden. 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 Malin Lövgren, PhD (0733302789, malin.lovgren@mchs.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychosocial needs (time frame: Through study completion, an average of 1 year). 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 21 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in