Clinical trial NCT02946697: A Culturally Sensitive Social Support Intervention
Official title: A Culturally Sensitive Social Support Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Keywords: Chinese
cancer survivors
Quality of Life
Social Support
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Herald Cancer Association
name: National Cancer Institute (NCI)
First posted: 2016-10-27
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized controlled trial (RCT) to assess the impact of a culturally based social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer survivors.

Detailed description: This study is a randomized controlled trial (RCT) to test the health benefits of an education and peer mentor support intervention. Chinese American breast cancer survivors who have completed primary treatment will be randomly assigned to either the intervention group or a control group to receive enhanced usual care while waiting for the JLA. Health outcomes are assessed at baseline, immediately post intervention, and 1 and 4 months follow-ups.

Eligibility criteria: Inclusion criteria:

* self-identified to be comfortable speaking Chinese (Mandarin or Cantonese)
* having a first breast cancer diagnosis of stages 0-III
* having completed primary treatment (surgery, chemotherapy, or radiotherapy) within the last 36 months

Exclusion criteria:

* unable to read or speak Chinese (Mandarin or Cantonese)
* breast cancer diagnosis of stage IV
* live outside of the LA area

Primary outcomes:
measure: Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)
timeFrame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Secondary outcomes:
measure: Change in depressive symptoms as assessed by CES-D
timeFrame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
measure: Change in positive affect as assessed by the PANAS
timeFrame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
measure: Change in fatigue as assessed by FACIT
timeFrame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
measure: Change in stress as assessed by the Perceived stress scale (PSS)
timeFrame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Other outcomes:
measure: Change in cortisol slope
timeFrame: Baseline before intervention and immediately
Locations:
city: Los Angeles
country: United States
facility: Herald Cancer Association
state: California
Study officials:
affiliation: University of Houston
name: Qian Lu, PhD; MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu Q, Warmoth K, Chen L, Wu CS, Chu Q, Li Y, Gallagher MW, Stanton AL, Kagawa Singer M, Young L, Loh A. A Culturally Sensitive Social Support Intervention for Chinese American Breast Cancer Survivors (Joy Luck Academy): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Sep 22;10(9):e30950. doi: 10.2196/30950.