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Online Psychosocial Program for Breast Cancer
N/A
Recruiting
Led By Terry Cheng
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks and 3month periods
Awards & highlights
Study Summary
This trial will compare the outcomes of two groups of women: those who receive the online psychosocial program and those who do not receive the program.
Who is the study for?
This trial is for foreign-born Chinese immigrant women with a new diagnosis of breast cancer (Stages 0-III). Participants must speak Cantonese or Mandarin as their mother tongue, be receiving surgery or radiation therapy (excluding those on Tamoxifen, bisphosphonates, and Herceptin), and be able to use a computer and read/speak English, Cantonese, or Mandarin. Women with recurrent or metastatic disease cannot participate.Check my eligibility
What is being tested?
The study tests an online psychosocial program designed for Chinese immigrant women with breast cancer. It aims to see if the program helps them feel supported, understand distress is normal, engage in self-care activities, become aware of community resources, gain confidence in returning to normal life after treatment and reduce overall distress by comparing participants who receive the program against those who do not.See study design
What are the potential side effects?
Since this is a psychosocial intervention focusing on emotional support rather than medical treatment there are no direct physical side effects expected from participating in the online program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks and 3month periods
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks and 3month periods
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changed awareness of self-care activities and resources
Changed confidence about returning to a normal life post-treatment
Changed feelings of support
+1 moreSecondary outcome measures
Changed emotional distress
Trial Design
2Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
Participants randomized to the Intervention Arm will be provided with the website link to the online psychosocial program and the questionnaire and distress survey. They will be asked to use the website within two weeks and then to complete the questionnaire and distress survey after using it and mail them back in a self-addressed stamped envelope. The participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. Those who have expressed an interest will be contacted.
Group II: Control GroupExperimental Treatment1 Intervention
Participants randomized to the Control group will receive standard care (no intervention). They will be used as a baseline to compare groups and assess the effect of the intervention (i.e., the online psychosocial program). At the two weeks following randomization (T1) and the 3-month follow-up periods (T2), they will be asked to complete the questionnaire and distress survey and return them in a self-addressed stamped envelope. Participants will be given two weeks to complete the questionnaire and distress survey. The same documents will be administered at the 3-month follow-up period (T2). Once the 3-month follow-up is completed, each participant will be provided with the website link to view the self-help program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention Arm
2017
N/A
~7590
Control Group
2012
Completed Phase 2
~2470
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
484,990 Total Patients Enrolled
53 Trials studying Breast Cancer
29,454 Patients Enrolled for Breast Cancer
Markham Stouffville HospitalOTHER
3 Previous Clinical Trials
2,367 Total Patients Enrolled
Terry ChengPrincipal InvestigatorPrincess Margaret Cancer Centre, University Health Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were recently diagnosed with early-stage breast cancer.Women who were born in China and speak Cantonese or Mandarin as their first language.You recently had surgery or radiation therapy as part of your treatment, except for specific medications like Tamoxifen, bisphosphonates, and Herceptin.Your cancer has come back or has spread to other parts of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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