Childhood CancerNCT02200731
FAMily Oriented Support (FAMOS): Psychosocial Intervention for Childhood Cancer Survivors and Their Families
A study testing FAMOS: psychosocial family intervention in people with Childhood Cancer, run by Pernille Bidstrup at 1 site in Denmark.
Trial summary
To investigate whether a home-based psychosocial family intervention that takes place shortly after ending the primary medical treatment can help families adjust to their cancer-related psychological issues. Read more about this study
- Who is it for?
- Ages Up to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- FAMOS: psychosocial family intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2014to Nov 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 Up to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families of children in the age range of 0-17 years diagnosed with any kind of cancer and treated at one of the four pediatric oncology departments in Denmark are invited to participate in the project after ending primary medical treatment.
Who cannot join
- If the child has a severe co-morbidity
- If the child has a mental disorder at diagnosis
- If the child is declared terminal ill at the end of treatment (less than 6 months of survival).
- If the parents and the children do not speak Danish. The participants have to be able to read and answer the questionnaires at the least, to be included in the project.
- If the parents do not wish to hand in consent form
- If the family participates in another randomized psychosocial intervention project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FAMOS: The Effect of Psychosocial Intervention for Childhood Cancer Survivors and Their Families: A Randomized Controlled Trial
To investigate whether a home-based psychosocial family intervention that takes place shortly after ending the primary medical treatment can help families adjust to their cancer-related psychological issues.
Read the detailed description
The objective of this randomized controlled trial is to investigate whether home-based psychosocial interventions are able to help families of childhood cancer survivors cope with cancer-related psychological issues.
Method: 300 families will be recruited from the four pediatric oncology departments in Denmark where 150 families' will receive a home-based psychosocial intervention and 150 families will be in the control group. The study will take place shortly after the child completes the primary treatment. The primary outcome is post-traumatic stress symptoms (PTSS) in parents and secondary outcomes include among others quality of life, sick-leave, coping strategies and family functioning. Families in the intervention group will receive a 6 session manualized intervention based on a Cognitive Behavioral framework. Four sessions will focus on the parents and two sessions will focus on the child, who had cancer, and his/her siblings. The main goal of the sessions is to teach families how to adapt healthy psychological adjustments to pediatric oncology and prevent PTSS in family members. As a part of the intervention, families will be presented with video clips of other parents discussing how cancer has affected their family, to show common issues in experiencing having a child undergo cancer treatment. Every family member will be asked to complete a set of questionnaires to measure the outcome of the intervention at baseline before the intervention, 6 months follow-up and 12 months follow-up.
It is expected that families in the intervention group experience a larger improvement in their post-traumatic stress symptoms as well as strengthening the family function, quality of life and reducing sick leave compared to the control group.
- Conditions
- Childhood Cancer
- Being tested
- FAMOS: psychosocial family intervention
- Keywords
- Childhood cancer, Psychosocial intervention, Family, Siblings, Childhood cancer survivors, Cogntive Behavioural, Manualized
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAMOS: psychosocial family interventionBehavioural
The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience
| Study group | Role | What they receive |
|---|---|---|
| FAMOS: psychosocial family intervention | Experimental | The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience. Receives: Behavioral: FAMOS: psychosocial family intervention |
| Control | No intervention | In Denmark, standard care after treatment does not include systematic psychosocial support. Families are able to seek support on their own or contact a support group offered by the Danish Cancer Society. However support specializing the families with childhood cancer survivors and their siblings after ending medial treatment is limited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 6 months follow up compared to parents in the control group
Measured: Baseline and 6 months
Secondary outcomes (10)
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 12 months follow up versus parents in the control group
Measured: Baseline and 12 months
Post traumatic stress symptoms (PTSS) in childhood cancer survivors and their siblings measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)
A larger reduction in PTSS from baseline to respectively 6 and 12 months follow up in childhood cancer survivors and their siblings the intervention group versus the control group measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)
Measured: Baseline, 6 months and 12 months
Family psychosocial functioning measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0)
An larger enhancement in the family's' psychosocial functioning from baseline to 6 months follow up and 12 months follow up measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0) in the intervention group versus the control group.
Measured: Baseline, 6 months and 12 months
Siblings perception measured by the Siblings Perception Questionnaire (SPQ)
A change in siblings' perception of how cancer affected their daily life from baseline to 6 months and 12 months follow-up measured by Sibling Perception Questionnaire (SPQ) in the intervention group versus the control group.
Measured: Baseline, 6 months and 12 months
Quality of life measured by Pediatric Quality of Life (PedsQL)
An enhancement in quality of life in childhood cancer survivors, their siblings and parents from baseline to 6 month and 12 month follow-up measured by Pediatric Quality of Life (PedsQL) in the intervention group versus the control group
Measured: Baseline, 6 months and 12 months
Self reported sick leave in parents
A larger reduction in sick leave for parents from baseline to 6 month and 12 month follow-up measured by self reporting in the intervention group versus the control group.
Measured: Baseline, 6 months and 12 months
Less stress induced telomere shortening
A 10 ml blood sample to measure whether a psychosocial intervention results in a less shortening of the telomere length amongst parents of childhood cancer survivors from baseline to 12 months follow up versus parents in the control group
Measured: Baseline and 12 months
Anxiety and depression in parents of childhood cancer survivors measured by the Symptom Checklist (SCL)
A larger reduction in anxiety and depression symptoms in parents of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group
Measured: Baseline, 6 months and 12 months
Anxiety and depression in siblings over 18 years of childhood cancer survivors measured by the Symptom Checklist (SCL)
A larger reduction in anxiety and depression symptoms in siblings over 18 years of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group
Measured: Baseline, 6 months and 12 months
Anxiety and depression in childhood cancer survivors and their siblings i the age range 8 to 17 years measured by the Revised Child Anxiety and Depression Scale (RCADS)
A larger reduction in anxiety and depression symptoms in childhood cancer survivors and their siblings i the age range 8 to 17 years in the intervention group from baseline to 6 and 12 months follow up compared to the control group
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood 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
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pernille Bidstrup
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital Skejby, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Pernille Bidstrup, Danish Cancer Society
- Investigators
- Christoffer Johansen, Phd, Dr. MEd, Principal investigator, Danish Cancer SocietyHanin Salem, Phd student, Principal investigator, Danish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200731
- Sponsor's protocol ID
- FAMOS
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2014
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bidstrup PE, Salem H, Andersen EW, Schmiegelow K, Rosthoj S, Wehner PS, Hasle H, Dalton SO, Johansen C, Kazak AE. Effects on Pediatric Cancer Survivors: The FAMily-Oriented Support (FAMOS) Randomized Controlled Trial. J Pediatr Psychol. 2023 Jan 12;48(1):29-38. doi: 10.1093/jpepsy/jsac062.
PubMed 35849020Salem H, Kazak AE, Andersen EW, Belmonte F, Johansen C, Schmiegelow K, Winther JF, Wehner PS, Hasle H, Rosthoj S, Bidstrup PE. Home-based cognitive behavioural therapy for families of young children with cancer (FAMOS): A nationwide randomised controlled trial. Pediatr Blood Cancer. 2021 Mar;68(3):e28853. doi: 10.1002/pbc.28853. Epub 2020 Dec 27.
PubMed 33369038
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAMOS: The Effect of Psychosocial Intervention for Childhood Cancer Survivors and Their Families: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02200731
- Acronym / sponsor ID
- FAMOS
- Conditions
- Childhood Cancer
- Keywords
- Childhood cancer, Psychosocial intervention, Family, Siblings, Childhood cancer survivors, Cogntive Behavioural, Manualized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Pernille BidstrupUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital Skejby, Aarhus University Hospital
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
To investigate whether a home-based psychosocial family intervention that takes place shortly after ending the primary medical treatment can help families adjust to their cancer-related psychological issues.
Detailed description
The objective of this randomized controlled trial is to investigate whether home-based psychosocial interventions are able to help families of childhood cancer survivors cope with cancer-related psychological issues.
Method: 300 families will be recruited from the four pediatric oncology departments in Denmark where 150 families' will receive a home-based psychosocial intervention and 150 families will be in the control group. The study will take place shortly after the child completes the primary treatment. The primary outcome is post-traumatic stress symptoms (PTSS) in parents and secondary outcomes include among others quality of life, sick-leave, coping strategies and family functioning. Families in the intervention group will receive a 6 session manualized intervention based on a Cognitive Behavioral framework. Four sessions will focus on the parents and two sessions will focus on the child, who had cancer, and his/her siblings. The main goal of the sessions is to teach families how to adapt healthy psychological adjustments to pediatric oncology and prevent PTSS in family members. As a part of the intervention, families will be presented with video clips of other parents discussing how cancer has affected their family, to show common issues in experiencing having a child undergo cancer treatment. Every family member will be asked to complete a set of questionnaires to measure the outcome of the intervention at baseline before the intervention, 6 months follow-up and 12 months follow-up.
It is expected that families in the intervention group experience a larger improvement in their post-traumatic stress symptoms as well as strengthening the family function, quality of life and reducing sick leave compared to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAMOS: psychosocial family intervention | Experimental | Behavioral: FAMOS: psychosocial family interventionThe FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience. |
| Control | No intervention | –In Denmark, standard care after treatment does not include systematic psychosocial support. Families are able to seek support on their own or contact a support group offered by the Danish Cancer Society. However support specializing the families with childhood cancer survivors and their siblings after ending medial treatment is limited. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Families of children in the age range of 0-17 years diagnosed with any kind of cancer and treated at one of the four pediatric oncology departments in Denmark are invited to participate in the project after ending primary medical treatment.
Key exclusion criteria (6 listed)
- If the child has a severe co-morbidity
- If the child has a mental disorder at diagnosis
- If the child is declared terminal ill at the end of treatment (less than 6 months of survival).
- If the parents and the children do not speak Danish. The participants have to be able to read and answer the questionnaires at the least, to be included in the project.
- If the parents do not wish to hand in consent form
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 |
|---|---|---|
| FAMOS: psychosocial family interventionThe FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience | Behavioural | FAMOS: psychosocial family intervention |
Primary outcome
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
Time frame: Baseline and 6 months
A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 6 months follow up compared to parents in the control group
10 secondary outcomes
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
Time frame: Baseline and 12 months
Post traumatic stress symptoms (PTSS) in childhood cancer survivors and their siblings measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)
Time frame: Baseline, 6 months and 12 months
Family psychosocial functioning measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0)
Time frame: Baseline, 6 months and 12 months
Siblings perception measured by the Siblings Perception Questionnaire (SPQ)
Time frame: Baseline, 6 months and 12 months
Quality of life measured by Pediatric Quality of Life (PedsQL)
Time frame: Baseline, 6 months and 12 months
Self reported sick leave in parents
Time frame: Baseline, 6 months and 12 months
Less stress induced telomere shortening
Time frame: Baseline and 12 months
Anxiety and depression in parents of childhood cancer survivors measured by the Symptom Checklist (SCL)
Time frame: Baseline, 6 months and 12 months
Anxiety and depression in siblings over 18 years of childhood cancer survivors measured by the Symptom Checklist (SCL)
Time frame: Baseline, 6 months and 12 months
Anxiety and depression in childhood cancer survivors and their siblings i the age range 8 to 17 years measured by the Revised Child Anxiety and Depression Scale (RCADS)
Time frame: Baseline, 6 months and 12 months
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 8 Feb 2021.
- Derived from this study: PubMed 35849020Bidstrup PE, Salem H, Andersen EW, Schmiegelow K, Rosthoj S, Wehner PS, Hasle H, Dalton SO, Johansen C, Kazak AE. Effects on Pediatric Cancer Survivors: The FAMily-Oriented Support (FAMOS) Randomized Controlled Trial. J Pediatr Psychol. 2023 Jan 12;48(1):29-38. doi: 10.1093/jpepsy/jsac062.
- Derived from this study: PubMed 33369038Salem H, Kazak AE, Andersen EW, Belmonte F, Johansen C, Schmiegelow K, Winther JF, Wehner PS, Hasle H, Rosthoj S, Bidstrup PE. Home-based cognitive behavioural therapy for families of young children with cancer (FAMOS): A nationwide randomised controlled trial. Pediatr Blood Cancer. 2021 Mar;68(3):e28853. doi: 10.1002/pbc.28853. Epub 2020 Dec 27.
- Individual participant dataSharing planned: Undecided
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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.
Christoffer Johansen, Phd, Dr. MEd principal investigator
Danish Cancer Society
Hanin Salem, Phd student principal investigator
Danish Cancer Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAMOS: psychosocial family intervention in people with Childhood Cancer, run by Pernille Bidstrup at 1 site in Denmark.
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 1 inclusion and 6 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 8 Feb 2021. 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 Denmark. 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?
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02200731, which also lists 2 linked publications.
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 8 Feb 2021.