An Impact Assessment of a Culturally Tailored Online Psychosocial Self-Help Program for Chinese Immigrant Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changed awareness of self-care activities and resources
研究概览
简要总结
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.
详细描述
This study will be conducted over a three-year period at the Princess Margaret Cancer Centre (PM), University Health Network. The mixed-methods study design will include a longitudinal survey and a focus group component. Quantitative assessments will be conducted at three time periods: pre-intervention (T0), within 2 weeks post-intervention (T1), and three months post-intervention (T2). Two small focus groups will be conducted to deepen the understanding of the participants', who received the online psychosocial program, experience of the intervention.
The online psychosocial self-help program (www.asianbrcarecovery.ca) website is hosted with University Health Network Digital, build on the SharePoint 2013 Platform. The website is an anonymous website with open access to the general public, including Control Group participants. They may come across the online psychosocial program if they search the internet for information. A question was included in the Control Group 3-month follow-up questionnaire to track if the participants found and used the website.
Recruitment. Recruitment will be conducted by a research assistant (RA) who is fluent in English and Chinese either in-person or by telephone. The oncologist will approach each patient coming to the hospital for treatment or from virtual visits using hospital approved Ontario Telemedicine Network and introduce the study. If the participant is interested to hear more about the study, the oncologist will ask for the participant's consent to release her contact information to the RA. The RA will contact the participant and explain the nature and demands of the study, go through the informed consent form with her, and answer any questions. If the participant agrees to participate, written informed consent, Participant Demographics questionnaire, and baseline distress survey (T0) will be mailed to the participant with a return self-addressed stamped envelope prior to randomization. The two community partners (South Riverdale Community Health Center and Senior Persons Living Connected) will also help with identifying participants. The group leaders at the monthly Chinese cancer psychoeducational groups will introduce the study and if the participant is interested, they will ask for the participant's consent to have her contact information provided to the RA. The recruitment process will remain the same. The participant will be asked to complete these documents in two weeks.
Participants will be randomly assigned in a 1:1 ratio to the online psychosocial intervention (INT) or the standard care control group (CTL) by using a list of randomly generated numbers (www. Random.org): when a participant is enrolled, she will be assigned the next consecutive number in the list. Participants receiving an odd number will be assigned to the CTL condition, and those receiving an even number will be assigned to the INT condition.
Intervention Arm. Following the receipt of completed baseline (T0) questionnaires, the participants randomized to the INT group will be provided with the website link to the online psychosocial program and a questionnaire and a distress survey. They will be asked to use the website within two weeks and then complete the questionnaire and distress survey after using it (T1) and mail them back in a self-addressed stamped envelope. The RA will call participants with a reminder if completed questionnaires have not been received by the third week. The questionnaire and survey will be administered at the 3-month follow-up period (T2) either at a participant's clinic visit or by mail, and the participant will be given two weeks to complete and return it in a self-addressed stamped envelope. A reminder call will be made after the two-week period. The questionnaires will take about 10 minutes to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •recurrence or metastatic disease
结局指标
主要结局
Changed awareness of self-care activities and resources
时间窗: 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.
Changed confidence about returning to a normal life post-treatment
时间窗: 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.
Changed feelings of their distress as normal
时间窗: 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.
Changed feelings of support
时间窗: 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.
次要结局
- Changed emotional distress(Baseline, 2 weeks and 3month periods)