Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer

NCT02787330 | Completed DMC

• 1 other identifier: 1000028990
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Cancer

Keywords

pediatric cancer; psychosocial; siblings

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  day 1, 8 weeks later, and 3 months after day 1

Secondary Outcomes (2)

• knowledge about cancer

  day 1, 8 weeks later, and 3 months after day 1

• quality of life

  day 1, 8 weeks later, and 3 months after day 1

Other Outcomes (2)

• exploratory outcome, maternal distress

  day 1, 8 weeks later, and 3 months after day 1

• perceived social support

  day 1, 8 weeks later, and 3 months after day 1

Study Arms (2)

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.

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.

Behavioral: Experimental Group

Interventions

Control Group BEHAVIORAL

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.

Control Group

Experimental Group BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (3)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

BC Women and Children's Hospital

Vancouver, British Columbia, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  PMID: 12730285 BACKGROUND

• Alderfer 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.

  PMID: 20582154 BACKGROUND

• Barrera, 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

• 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.

  PMID: 16317733 BACKGROUND

• Kamibeppu 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.

  PMID: 20396974 BACKGROUND

• Packman 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.

  PMID: 20383219 BACKGROUND

• Lown 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.

  PMID: 18554347 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maru Barrera, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: June 1, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)