CancerNCT02787330
Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer
A study testing Experimental Group in people with Cancer, run by The Hospital for Sick Children at 3 sites in Canada.
Trial summary
The psychosocial effects of childhood cancer and its demanding medical treatment can affect not only the ill child but the whole family, particularly siblings who are often overlooked given the terrible circumstances these families face. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Cancer
- What is being tested?
- Experimental Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2011to Dec 2016
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Siblings of children on active cancer treatment at one or the three sites; at least three months from diagnosis to reduce parental burden
- Siblings and one caregiver are fluent in English, ensuring full participation
- Siblings are age 8-16 years
Who cannot join
- Siblings who are diagnosed with a developmental or psychiatric disorder which will prevent full group participation
- Are receiving active psychological treatment at the time of recruitment
- Has a brother/sister who is receiving palliative care, and is not expected to live longer than 6 months or who had died.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Alberta Children's Hospital
Calgary, Alberta
The Hospital for Sick Children
Toronto, Ontario, M5V1X8
BC Women and Children's Hospital
Vancouver, British Columbia
About this study
The psychosocial effects of childhood cancer and its demanding medical treatment can affect not only the ill child but the whole family, particularly siblings who are often overlooked given the terrible circumstances these families face. Current evidence suggests that negative long-term psychosocial effects of childhood cancer may be more severe in siblings than in the child with cancer. Addressing these effects on siblings may benefit the child with cancer and the entire family. Thus, early psychosocial preventive interventions are needed to foster psychosocial adjustment in siblings and promote better quality of life for the entire family. The immediate objective of this study is to address siblings' psychological distress by assessing feasibility and efficacy of a manualized group intervention for siblings of children with cancer (Siblings Coping Together, SibCT). A longer term objective is that the evidence-based intervention could then be exported to other centres across Canada and internationally. Additionally, the study results will identify biomedical, personal, familial and social determinants of intervention outcomes that can guide clinical effort for those at greatest risk. Finally, the overall aim of the project is to reduce psychological distress and improve quality of life for siblings and families impacted by a cancer diagnosis and its demanding treatment.
Read the detailed description
Siblings of children with cancer can endure great psychological distress as a result of their brother's or sister's diagnosis and treatment. Understandably, when a child has cancer, their parents' attention is focused mainly on that child and therefore the siblings' needs may not be fully addressed. Thus, siblings often develop feelings of anger, abandonment, jealousy, and fear, which may lead to an increased risk for academic difficulties, symptoms of depression and anxiety and post traumatic stress disorder, although the results are not consistent across studies. Of most concern is that psychological problems may persist through adulthood, as suggested by a recent study in which alcoholism was more prevalent among siblings of children with cancer when compared to peers and cancer survivors. Therefore, it is imperative to develop evidence based psychological intervention programs to prevent these detrimental psychological effects in siblings of children with cancer. This project aims to address siblings' psychological distress by assessing the efficacy of a manualized group intervention for siblings of children with cancer (SibCT) across three Canadian sites (SickKids, Alberta Children's Hospital, BC Women and Children's Hospital) using a randomized control trial (RCT) experimental design. A manualized intervention is considered the gold standard for psychological intervention as it ensures replicability of the study and intervention fidelity. The primary aim is to demonstrate that survivors in the SibCT group (EG) demonstrate decreased symptoms of depression and anxiety improve their overall quality of life compared to an attention control group (CG). A secondary aim is to show that compared to CG, EG will show improvements in secondary measures of quality of life as well as knowledge about cancer. We will also explore other factors such as disease and treatment variables, social contextual variables, individual (sibling) variables and family variables. Randomized Control Trial design with repeated measures will be used. Siblings of children on active cancer treatment and at least 3 months from diagnosis to reduce parental burden; between 8-16 years of age will be included in the study. Siblings will be randomized to either the EG or CG. Approximately 184 siblings will be recruited across the three pediatric centres. After baseline assessment, both groups will have 8 two-hour weekly group sessions consisting of arts and crafts and games, and two post-intervention assessments; at the end of session 8 and three months later. In the EG the critical ingredient has education and social and therapeutic problem solving components based on the manual. Examples of weekly session topics include: age-appropriate medical information about cancer; siblings' fears and feelings; relationships at school, etc. The CG will not have any education or therapeutic-based components. Rigorous testing of the efficacy of an intervention program is a critical step for developing evidence-based treatments.
- Conditions
- Cancer
- Being tested
- Control Group, Experimental Group
- Keywords
- pediatric cancer, psychosocial, siblings
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupBehavioural
Sessions will not be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.
Experimental GroupBehavioural
The experimental group will be detailed, session by session, in the manual written for this purpose. It addresses on topic per session (respecting each other, medical information about cancer, family relationships, sibling's fears and feelings, relationship between siblings, relationships at school, generating hope.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Behavioural: Participants in this arm will experience an 8-week manualized intervention program with activities and games. Sessions will NOT be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will NOT have a specific focus. Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site. Receives: Behavioral: Control Group |
| Experimental Group | Experimental | Behavioural: Participants in this arm will experience an 8-week manualized intervention program which focuses on education, therapeutic problem solving, and social support. Each intervention session is structured by theme relevant to the cancer experience and themes are addressed through fun activities, games, arts, and crafts.To maximize the therapeutic effect of the intervention fun work (homework) will be assigned after each session. Training for the EG facilitators requires reading and studying the manual to become fully familiarized with the intervention approaches, observing group sessions through a one-way mirror prior to participation as a group facilitator, and participating as a group facilitator assistant for the intervention program. Receives: Behavioral: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline depression scores at end of intervention and 3 months
Measured by Childhood Depression Inventory (CDI) [Kovacs, 1992]. ). This self-rated, 27-item scale was designed for children between the ages of 7-17.
Measured: day 1, 8 weeks later, and 3 months after day 1
Change from baseline anxiety scores at end of intervention and 3 months
Measured by State Trait Anxiety Inventory for Children (STAIC)( Spielberger, 1983). This is a 20-item self-report measure
Measured: day 1, 8 weeks later, and 3 months after day 1
Secondary outcomes (2)
knowledge about cancer
Siblings Perception Questionnaire (SPQ) (Barbarin, 1995) is a 17-item questionnaire specifically designed for siblings of children with cancer
Measured: day 1, 8 weeks later, and 3 months after day 1
quality of life
Pediatric Quality of Life Inventory (PedsQL 4.0 Varni, 1999) is a 23-item, standardized generic measure of health related QOL. The PedsQL, self-report and parent proxy, is composed of four subscales: Physical, Social, Emotional and School Functioning and a Total score.
Measured: day 1, 8 weeks later, and 3 months after day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maru Barrera, The Hospital for Sick Children
- Investigators
- Maru Barrera, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787330
- Sponsor's protocol ID
- 1000028990
- Status last verified
- Oct 2017
- First submitted
- 9 May 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Barrera, M, Chung, JJ, Greenberg, M & Fleming, CF. Preliminary investigation of a group intervention for siblings of pediatric cancer patients. Children's Health Care, 31(2), 131-142, 2002.
Alderfer MA, Labay LE, Kazak AE. Brief report: does posttraumatic stress apply to siblings of childhood cancer survivors? J Pediatr Psychol. 2003 Jun;28(4):281-6. doi: 10.1093/jpepsy/jsg016.
PubMed 12730285Alderfer MA, Hodges JA. Supporting Siblings of Children with Cancer: A Need for Family-School Partnerships. School Ment Health. 2010 Jun 1;2(2):72-81. doi: 10.1007/s12310-010-9027-4.
PubMed 20582154Barrera, M., Chung, J. J., & Fleming, C. F. (2004). A group intervention for siblings of pediatric cancer patients. Journal of Psychological Oncology, 22(2), 21-39.
Sidhu R, Passmore A, Baker D. The effectiveness of a peer support camp for siblings of children with cancer. Pediatr Blood Cancer. 2006 Oct 15;47(5):580-8. doi: 10.1002/pbc.20653.
PubMed 16317733Kamibeppu K, Sato I, Honda M, Ozono S, Sakamoto N, Iwai T, Okamura J, Asami K, Maeda N, Inada H, Kakee N, Horibe K, Ishida Y. Mental health among young adult survivors of childhood cancer and their siblings including posttraumatic growth. J Cancer Surviv. 2010 Dec;4(4):303-12. doi: 10.1007/s11764-010-0124-z. Epub 2010 Apr 16.
PubMed 20396974Packman W, Weber S, Wallace J, Bugescu N. Psychological effects of hematopoietic SCT on pediatric patients, siblings and parents: a review. Bone Marrow Transplant. 2010 Jul;45(7):1134-46. doi: 10.1038/bmt.2010.74. Epub 2010 Apr 12.
PubMed 20383219Lown EA, Goldsby R, Mertens AC, Greenfield T, Bond J, Whitton J, Korcha R, Robison LL, Zeltzer LK. Alcohol consumption patterns and risk factors among childhood cancer survivors compared to siblings and general population peers. Addiction. 2008 Jul;103(7):1139-48. doi: 10.1111/j.1360-0443.2008.02242.x.
PubMed 18554347
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer
- ClinicalTrials.gov ID
- NCT02787330
- Acronym / sponsor ID
- 1000028990
- Conditions
- Cancer
- Keywords
- pediatric cancer, psychosocial, siblings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jun 2016 (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.
The psychosocial effects of childhood cancer and its demanding medical treatment can affect not only the ill child but the whole family, particularly siblings who are often overlooked given the terrible circumstances these families face. Current evidence suggests that negative long-term psychosocial effects of childhood cancer may be more severe in siblings than in the child with cancer. Addressing these effects on siblings may benefit the child with cancer and the entire family. Thus, early psychosocial preventive interventions are needed to foster psychosocial adjustment in siblings and promote better quality of life for the entire family. The immediate objective of this study is to address siblings' psychological distress by assessing feasibility and efficacy of a manualized group intervention for siblings of children with cancer (Siblings Coping Together, SibCT). A longer term objective is that the evidence-based intervention could then be exported to other centres across Canada and internationally. Additionally, the study results will identify biomedical, personal, familial and social determinants of intervention outcomes that can guide clinical effort for those at greatest risk. Finally, the overall aim of the project is to reduce psychological distress and improve quality of life for siblings and families impacted by a cancer diagnosis and its demanding treatment.
Detailed description
Siblings of children with cancer can endure great psychological distress as a result of their brother's or sister's diagnosis and treatment. Understandably, when a child has cancer, their parents' attention is focused mainly on that child and therefore the siblings' needs may not be fully addressed. Thus, siblings often develop feelings of anger, abandonment, jealousy, and fear, which may lead to an increased risk for academic difficulties, symptoms of depression and anxiety and post traumatic stress disorder, although the results are not consistent across studies. Of most concern is that psychological problems may persist through adulthood, as suggested by a recent study in which alcoholism was more prevalent among siblings of children with cancer when compared to peers and cancer survivors. Therefore, it is imperative to develop evidence based psychological intervention programs to prevent these detrimental psychological effects in siblings of children with cancer. This project aims to address siblings' psychological distress by assessing the efficacy of a manualized group intervention for siblings of children with cancer (SibCT) across three Canadian sites (SickKids, Alberta Children's Hospital, BC Women and Children's Hospital) using a randomized control trial (RCT) experimental design. A manualized intervention is considered the gold standard for psychological intervention as it ensures replicability of the study and intervention fidelity. The primary aim is to demonstrate that survivors in the SibCT group (EG) demonstrate decreased symptoms of depression and anxiety improve their overall quality of life compared to an attention control group (CG). A secondary aim is to show that compared to CG, EG will show improvements in secondary measures of quality of life as well as knowledge about cancer. We will also explore other factors such as disease and treatment variables, social contextual variables, individual (sibling) variables and family variables. Randomized Control Trial design with repeated measures will be used. Siblings of children on active cancer treatment and at least 3 months from diagnosis to reduce parental burden; between 8-16 years of age will be included in the study. Siblings will be randomized to either the EG or CG. Approximately 184 siblings will be recruited across the three pediatric centres. After baseline assessment, both groups will have 8 two-hour weekly group sessions consisting of arts and crafts and games, and two post-intervention assessments; at the end of session 8 and three months later. In the EG the critical ingredient has education and social and therapeutic problem solving components based on the manual. Examples of weekly session topics include: age-appropriate medical information about cancer; siblings' fears and feelings; relationships at school, etc. The CG will not have any education or therapeutic-based components. Rigorous testing of the efficacy of an intervention program is a critical step for developing evidence-based treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Control GroupBehavioural: Participants in this arm will experience an 8-week manualized intervention program with activities and games. Sessions will NOT be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will NOT have a specific focus. Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site. |
| Experimental Group | Experimental | Behavioral: Experimental GroupBehavioural: Participants in this arm will experience an 8-week manualized intervention program which focuses on education, therapeutic problem solving, and social support. Each intervention session is structured by theme relevant to the cancer experience and themes are addressed through fun activities, games, arts, and crafts.To maximize the therapeutic effect of the intervention fun work (homework) will be assigned after each session. Training for the EG facilitators requires reading and studying the manual to become fully familiarized with the intervention approaches, observing group sessions through a one-way mirror prior to participation as a group facilitator, and participating as a group facilitator assistant for the intervention program. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Siblings of children on active cancer treatment at one or the three sites; at least three months from diagnosis to reduce parental burden
- Siblings and one caregiver are fluent in English, ensuring full participation
- Siblings are age 8-16 years
Key exclusion criteria (3 listed)
- Siblings who are diagnosed with a developmental or psychiatric disorder which will prevent full group participation
- Are receiving active psychological treatment at the time of recruitment
- Has a brother/sister who is receiving palliative care, and is not expected to live longer than 6 months or who had died.
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 |
|---|---|---|
| Control GroupSessions will not be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site. | Behavioural | Control Group |
| Experimental GroupThe experimental group will be detailed, session by session, in the manual written for this purpose. It addresses on topic per session (respecting each other, medical information about cancer, family relationships, sibling's fears and feelings, relationship between siblings, relationships at school, generating hope. | Behavioural | Experimental Group |
Primary outcome
Change from baseline depression scores at end of intervention and 3 months
Time frame: day 1, 8 weeks later, and 3 months after day 1
Measured by Childhood Depression Inventory (CDI) [Kovacs, 1992]. ). This self-rated, 27-item scale was designed for children between the ages of 7-17.
Change from baseline anxiety scores at end of intervention and 3 months
Time frame: day 1, 8 weeks later, and 3 months after day 1
Measured by State Trait Anxiety Inventory for Children (STAIC)( Spielberger, 1983). This is a 20-item self-report measure
2 secondary outcomes
knowledge about cancer
Time frame: day 1, 8 weeks later, and 3 months after day 1
quality of life
Time frame: day 1, 8 weeks later, and 3 months after day 1
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 27 Oct 2017.
- BackgroundBarrera, M, Chung, JJ, Greenberg, M & Fleming, CF. Preliminary investigation of a group intervention for siblings of pediatric cancer patients. Children's Health Care, 31(2), 131-142, 2002.
- Background: PubMed 12730285Alderfer MA, Labay LE, Kazak AE. Brief report: does posttraumatic stress apply to siblings of childhood cancer survivors? J Pediatr Psychol. 2003 Jun;28(4):281-6. doi: 10.1093/jpepsy/jsg016.
- Background: PubMed 20582154Alderfer MA, Hodges JA. Supporting Siblings of Children with Cancer: A Need for Family-School Partnerships. School Ment Health. 2010 Jun 1;2(2):72-81. doi: 10.1007/s12310-010-9027-4.
- BackgroundBarrera, M., Chung, J. J., & Fleming, C. F. (2004). A group intervention for siblings of pediatric cancer patients. Journal of Psychological Oncology, 22(2), 21-39.
- Background: PubMed 16317733Sidhu R, Passmore A, Baker D. The effectiveness of a peer support camp for siblings of children with cancer. Pediatr Blood Cancer. 2006 Oct 15;47(5):580-8. doi: 10.1002/pbc.20653.
- Background: PubMed 20396974Kamibeppu K, Sato I, Honda M, Ozono S, Sakamoto N, Iwai T, Okamura J, Asami K, Maeda N, Inada H, Kakee N, Horibe K, Ishida Y. Mental health among young adult survivors of childhood cancer and their siblings including posttraumatic growth. J Cancer Surviv. 2010 Dec;4(4):303-12. doi: 10.1007/s11764-010-0124-z. Epub 2010 Apr 16.
- Background: PubMed 20383219Packman W, Weber S, Wallace J, Bugescu N. Psychological effects of hematopoietic SCT on pediatric patients, siblings and parents: a review. Bone Marrow Transplant. 2010 Jul;45(7):1134-46. doi: 10.1038/bmt.2010.74. Epub 2010 Apr 12.
- Background: PubMed 18554347Lown EA, Goldsby R, Mertens AC, Greenfield T, Bond J, Whitton J, Korcha R, Robison LL, Zeltzer LK. Alcohol consumption patterns and risk factors among childhood cancer survivors compared to siblings and general population peers. Addiction. 2008 Jul;103(7):1139-48. doi: 10.1111/j.1360-0443.2008.02242.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maru Barrera, PhD principal investigator
The Hospital for Sick Children
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Cancer, run by The Hospital for Sick Children at 3 sites in Canada.
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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline depression scores at end of intervention and 3 months (time frame: day 1, 8 weeks later, and 3 months after day 1). The study lists 2 primary outcomes in all. 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 NCT02787330, which also lists 8 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 27 Oct 2017.