Chinese Immigrants With Breast CancerNCT01632956
Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer
An observational study of Chinese Immigrants With Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
There are few breast cancer support groups that focus on the specific needs of Chinese women. The purpose of this study is to learn about two different ways of providing support groups to help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and its treatment. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Chinese Immigrants With Breast Cancer
- What is being tested?
- in-person support group and virtual support group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment will be conducted by the MSKCC Research Study Assistant (RSA) with the assistance of the treatment team and community partners. Patients of MSKCC and QCC will be approached in clinic waiting rooms by the RSA. ACS Asian Initiatives and the Charles B Wang Community Health Center are referral sites for this study.
Who may be able to join
- Female
- Non-US born
- Resident in the US < 20 years
- Of Chinese descent
- Age 21 years through 80 years
- Language spoken: Mandarin
Show all 11Show fewer
- Diagnosis of breast cancer within 3 months prior to recruitment
- Not required that breast cancer is the patients' first and/or only cancer diagnosis
- Currently receiving cancer treatment;
- Will be living continuously in the US for the next year
- Has a telephone that he/she is willing to use for the study
Who cannot join
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
- Another household member is already enrolled.
- Prior participation in a cancer support group
Trial locations and contacts
1 site in 1 country.
United States1 site
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
About this study
Official title: Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer: A Pilot Study
There are few breast cancer support groups that focus on the specific needs of Chinese women. The purpose of this study is to learn about two different ways of providing support groups to help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and its treatment. The investigators want to learn about how best to support Chinese women with breast cancer by providing two different types of groups: an in-person support group and a virtual (online/phone) support group.
- Conditions
- Chinese Immigrants With Breast Cancer
- Being tested
- in-person support group, virtual support group
- Keywords
- Support Groups, Breast cancer, Mandarin speaking, 12-105
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-person support groupBehavioural
Each support group will consist of 12 sessions. Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups).
virtual support groupBehavioural
Each support group will consist of 12 sessions. Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups).
| Study group | Role | What they receive |
|---|---|---|
| in-person support group | This is a 1 year pilot study of the feasibility of participation in both in-person and virtual information-based, culturally tailored support groups for Chinese breast cancer patients. Receives: Behavioral: in-person support group | |
| virtual support group | This is a 1 year pilot study of the feasibility of participation in both in-person and virtual information-based, culturally tailored support groups for Chinese breast cancer patients. Receives: Behavioral: virtual support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility
To pilot and evaluate the feasibility of information-based, culturally-tailored in-person and virtual support groups for Chinese patients with breast cancer. The feasibility of participation in the in-person and virtual support groups will be measured by documenting patient accrual to the pilot study and attendance at the support groups.
Measured: 1 year
Secondary outcomes (3)
To compare the impact of participation
in the in-person versus virtual support groups on quality of life (QOL), pain, psychosocial outcomes (distress, depression, anxiety, self-efficacy in coping with cancer), and perceived social support. These outcomes will be measured through a baseline and exit Outcomes Survey.
Measured: 1 year
To assess satisfaction with the support groups
All participants will complete the Brief Support Group Survey at the end of each support meeting to assess satisfaction with and to provide feedback on the usefulness of the meeting and the information presented, ease of understanding and cultural appropriateness of the information, effectiveness of the facilitator, and suggestions for change or improvement.
Measured: 1 year
To assess Internet use
among support group participants. All patients approached for study participation will complete the Screening Tool, which includes questions related to Internet use. The Screening Tool will be used for all eligible patients (patients refusing to participate will still be asked to complete the screening tool).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chinese Immigrants With Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Support Community, CHARLES B WANG COMMUNITY HEALTH CENTER, Queens Health Network
- Responsible party
- Sponsor
- Investigators
- Jennifer Leng, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632956
- Sponsor's protocol ID
- 12-105
- Status last verified
- Feb 2014
- First submitted
- 29 Jun 2012
- Last updated
- 6 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT01632956
- Acronym / sponsor ID
- 12-105
- Conditions
- Chinese Immigrants With Breast Cancer
- Keywords
- Support Groups, Breast cancer, Mandarin speaking, 12-105
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Support Community, CHARLES B WANG COMMUNITY HEALTH CENTER, Queens Health Network
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are few breast cancer support groups that focus on the specific needs of Chinese women. The purpose of this study is to learn about two different ways of providing support groups to help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and its treatment. The investigators want to learn about how best to support Chinese women with breast cancer by providing two different types of groups: an in-person support group and a virtual (online/phone) support group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in-person support group | – | Behavioral: in-person support groupThis is a 1 year pilot study of the feasibility of participation in both in-person and virtual information-based, culturally tailored support groups for Chinese breast cancer patients. |
| virtual support group | – | Behavioral: virtual support groupThis is a 1 year pilot study of the feasibility of participation in both in-person and virtual information-based, culturally tailored support groups for Chinese breast cancer patients. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be conducted by the MSKCC Research Study Assistant (RSA) with the assistance of the treatment team and community partners. Patients of MSKCC and QCC will be approached in clinic waiting rooms by the RSA. ACS Asian Initiatives and the Charles B Wang Community Health Center are referral sites for this study.
Key inclusion criteria (11 listed)
- Female
- Non-US born
- Resident in the US < 20 years
- Of Chinese descent
- Age 21 years through 80 years
Key exclusion criteria (3 listed)
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
- Another household member is already enrolled.
- Prior participation in a cancer support group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-person support groupEach support group will consist of 12 sessions. Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups). | Behavioural | in-person support group |
| virtual support groupEach support group will consist of 12 sessions. Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups). | Behavioural | virtual support group |
Primary outcome
feasibility
Time frame: 1 year
To pilot and evaluate the feasibility of information-based, culturally-tailored in-person and virtual support groups for Chinese patients with breast cancer. The feasibility of participation in the in-person and virtual support groups will be measured by documenting patient accrual to the pilot study and attendance at the support groups.
3 secondary outcomes
To compare the impact of participation
Time frame: 1 year
To assess satisfaction with the support groups
Time frame: 1 year
To assess Internet use
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Leng, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chinese Immigrants With Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.