NCT00418444

Brief Summary

The purpose of this study is to test an innovative intervention geared towards issues of identity, body image and sexuality, and to examine the intervention for its impact on body image, quality of life, psychosocial/sexuality/relational functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 2, 2015

Status Verified

January 1, 2007

Enrollment Period

2.9 years

First QC Date

January 2, 2007

Last Update Submit

June 30, 2015

Conditions

Breast Neoplasms

Keywords

Breast cancer,group psychotherapy,RCT,women's mental health

Outcome Measures

Primary Outcomes (1)

  • Self image and communication(using standardized instruments)

Secondary Outcomes (2)

  • Psychosocial and psychosexual functioning (using standardized instruments)

  • Relational functioning, quality of life and health care utilization (using standardized instruments)

Interventions

Group Therapy InterventionBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with primary breast cancer
  • age between 18 and 65 years
  • completed adjuvant treatments
  • Stage I,II,III cancer of the breast with no metastatic disease

You may not qualify if:

  • presence of any metastases
  • history of major psychiatric disorder as defined by the DSM-IV
  • inability to speak or read English for questionnaire completion
  • failure to provide informed consent
  • currently participating in a therapist-led psychosocial support group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • Esplen MJ, Wong J, Warner E, Toner B. Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial. J Clin Oncol. 2018 Mar 10;36(8):749-756. doi: 10.1200/JCO.2017.74.8244. Epub 2018 Jan 22.

    PMID: 29356610DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mary Jane Esplen, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 2, 2015

Record last verified: 2007-01

Locations

CA(2)