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An Impact Assessment of a Culturally Tailored Online Psychosocial Program for Chinese Immigrant Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT04656353
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
Markham Stouffville Hospital
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

The purpose of the study is to evaluate the effectiveness of an online psychosocial self-help program for Chinese immigrant women with breast cancer, by comparing Chinese immigrant women who receive the online psychosocial program and those who do not receive the program.

The investigators want to understand if this online psychosocial program is effective in helping Chinese immigrant women to feel more supported, understand that the distress is normal, engage in self-care activities, become aware of the community resources, feel more confident about returning to a normal life, and feel less distress overall as they return to life after treatment. This information will help us to better understand these Chinese immigrant women's needs and concerns and plan future growth of the program to meet their personal, cultural, and language needs.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Intervention Arm Behavioral: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Impact Assessment of a Culturally Tailored Online Psychosocial Self-Help Program for Chinese Immigrant Women With Breast Cancer
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Intervention Arm
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.
Behavioral: Intervention Arm
Participants randomized to the Intervention Arm will be provided with the website link to the online self-help program and a questionnaire and a distress survey. They will be asked to use the website within two weeks and then to complete these documents after using it and mail them back in a self-addressed stamped envelope. Same documents will be administered at the 3-month follow-up period, and the participant will be given two weeks to complete and return it in a self-addressed stamped envelope. Additionally, 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. The focus groups will last about 1-1.5 hours and consist of 3-4 participants. Focus groups will be audio-taped and conducted in either English or Chinese.

Experimental: Control Group
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.
Behavioral: Control Group
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.




Primary Outcome Measures :
  1. Changed feelings of support [ Time Frame: Baseline, 2 weeks and 3-month periods ]
    A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

  2. Changed feelings of their distress as normal [ Time Frame: Baseline, 2 weeks and 3-month periods ]
    A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

  3. Changed awareness of self-care activities and resources [ Time Frame: Baseline, 2 weeks and 3-month periods ]
    A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

  4. Changed confidence about returning to a normal life post-treatment [ Time Frame: Baseline, 2 weeks and 3-month periods ]
    A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.


Secondary Outcome Measures :
  1. Changed emotional distress [ Time Frame: Baseline, 2 weeks and 3month periods ]
    Hospital Anxiety and Depression Scale (HADS) is a 4-item scale used to assess levels of anxiety and depression in cancer populations. It is a well validated and frequently used self-reported measure consisting of a 4-point Likert rating scale ranging from 0 (not a problem) to 3 (high level of problems).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Foreign-born Chinese immigrant women who identify their mother tongue as either Cantonese or Mandarin
  • A diagnosis of new breast cancer (Stages 0-III)
  • Receiving surgery (i.e., mastectomy) or adjuvant radiation therapy as the last hospital-based treatment, with the exception of Tamoxifen, bisphosphonates, and Herceptin
  • Able to use a computer
  • Able to read and speak English, Cantonese, or Mandarin.

Exclusion Criteria:

  • recurrence or metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656353


Contacts
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Contact: Terry Cheng, PhD 416-946-2197 terry.cheng@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Terry Cheng, PhD    416-946-2197    terry.cheng@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Markham Stouffville Hospital
Investigators
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Principal Investigator: Terry Cheng Princess Margaret Cancer Centre, University Health Network
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04656353    
Other Study ID Numbers: 20-5215.0
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Breast cancer
Chinese women
psychosocial
online program
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases