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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01632956
Other study ID # 12-105
Secondary ID
Status Withdrawn
Phase N/A
First received June 29, 2012
Last updated February 5, 2014
Start date June 2012
Est. completion date June 2014

Study information

Verified date February 2014
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria:

- Female

- Non-US born

- Resident in the US < 20 years

- Of Chinese descent

- Age 21 years through 80 years

- Language spoken: Mandarin

- 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

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
in-person support group
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 group
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).

Locations

Country Name City State
United States Queens Cancer Center of Queens Hospital Jamaica New York

Sponsors (4)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Cancer Support Community, CHARLES B WANG COMMUNITY HEALTH CENTER, Queens Health Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year No
Secondary 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. 1 year No
Secondary 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. 1 year No
Secondary 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). 1 year No