Official Title
An Impact Assessment of a Culturally Tailored Online Psychosocial Self-Help Program for Chinese Immigrant Women With Breast Cancer
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.
Trial Description
Primary Outcome:
- Changed feelings of support
- Changed feelings of their distress as normal
- Changed awareness of self-care activities and resources
- Changed confidence about returning to a normal life post-treatment
Secondary Outcome:
- Changed emotional distress
This study will be conducted over a two-year period at the
Princess Margaret Cancer Centre (PM), University Health Network and Markham
Stouffville Hospital (MSH) with PM as lead/coordinating site. 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.
INT 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. For 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; the small group size will afford more
focused solicitation of the primary outcomes. Focus groups will be audio-taped
and conducted in either English or Chinese.
Control Group. Participants randomized to the CTL group will
receive standard care. At the two weeks following randomization (T1) and the
3-month follow-up periods (T2), the RA will mail the questionnaire and distress
survey for completion. Participants will be given two weeks to complete the
questionnaire and distress survey. A self-addressed stamped envelope will be
provided to mail them back. A reminder call will be made after the two-week
period. The questionnaire and distress survey will be administered at the
3-month follow-up period (T2) either at the participant's clinic visit or by
mail. The questionnaires will take about 10 minutes to complete. Once the
3-month follow-up package is received, each participant will be provided with
the website link to view the self-help program.
Data Collection. Quantitative data will be collected with a
pre/post measure of emotional distress (anxiety and depression),
questionnaires, and website analytics (e.g., number of visits to the website
per individual). All measures used in the study will be available in both
English and Chinese (traditional and simplified versions), and participants
will be asked about their language preference. Qualitative data will be
collected from two small focus groups.
Measures. Socio-demographic and medical information will be
collected with a self-report information form (Patient Demographics
questionnaire) created by the research team. Any study materials that are in
English (i.e., consent forms, socio-demographic information form, and
questionnaires) will be professionally translated to Chinese (simplified and
traditional), to accommodate the diversity in the Chinese population. The
translated documents will be reviewed by the Chinese members of the team and
recommendations made until acceptable Chinese-translated versions are agreed
upon.
Statistical Analysis. Data will be analyzed using SPSS
version 25. Participant characteristics and baseline outcome measures will be
summarized using descriptive statistics. The equivalence of groups at baseline
on basic demographic and medical variables will be assessed using independent
t-tests and chi-square tests, and variables demonstrating any significant group
differences (p<.05) will be included as covariates in the primary analyses.
A data dictionary will be created containing detailed descriptions of each variable
and coding information. Data checks will be verified by the study investigator.
To evaluate the effect of the online self-help program, the
main and interaction effects of treatment group (INT and CTL) and time (T0, T1,
and T2) on each of the primary outcomes will be examined using separate mixed
ANCOVA models, controlling for any empirically identified covariates. Hedges' g
and associated confidence intervals will be calculated to estimate effect sizes
both over time (within groups) and between groups. Alpha will be set at 0.05,
and probability values will be two-tailed. Missing data will be evaluated on a
case-by-case basis such that drop-outs will be excluded.
Qualitative Data Analysis. Focus group interviews will be
transcribed verbatim. Content analysis will be used to analyze focus group
transcripts and identify categories and themes. Constant comparison will be
undertaken by staying close to the data, identifying negative cases, and
comparing themes and patterns. NVivo 10 will be used for data management.
A small honorarium will be provided to each participant at
every single time period they complete the measures to compensate for the time
taken to participate. Similarly, a small honorarium will be provided to the
participants attending the focus groups to compensate them for their time and
transportation expenses.
View this trial on ClinicalTrials.gov
