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Trial record 10 of 458 for:    Alcohol* OR Cocaine OR Shizophrenia OR social | Studies received from 08/01/2016 to 01/16/2017

A Culturally Sensitive Social Support Intervention (JLA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of Houston
Sponsor:
Collaborators:
University of California, Los Angeles
Herald Cancer Association
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Qian Lu, University of Houston
ClinicalTrials.gov Identifier:
NCT02946697
First received: October 25, 2016
Last updated: November 3, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Breast Cancer
Breast Neoplasms
Behavioral: Social support intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Culturally Sensitive Social Support Intervention

Resource links provided by NLM:


Further study details as provided by University of Houston:

Primary Outcome Measures:
  • Change in Quality of life as assessed by FACT [ Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention ]

Secondary Outcome Measures:
  • Change in depressive symptoms as assessed by CES-D [ Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention ]
    Depressive symptoms will be measured with the Chinese short-form version (Boey, 1999) of the Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) as well as two additional items ("I don't want to have contact with people, socialize, or go out at all" and "I have thought about hurting myself") from the Chinese American Depression Scale (CADS-9).

  • Change in positive affect as assessed by the PANAS [ Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention ]
  • Change in fatigue as assessed by FACIT [ Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention ]
    A short-version (i.e. 6-item) of Functional Assessment of Chronic Illness Therapy-Fatigue scale was used.

  • Change in stress as assessed by the Perceived stress scale (PSS) [ Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention ]
  • Change in cortisol slope [ Time Frame: Baseline before intervention and immediately ]

Estimated Enrollment: 190
Study Start Date: January 2015
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Ehanced care and wait-list control group
Participants in the control group will receive enhanced usual care while waiting for the JLA program. Participants will be given information booklets in Chinese developed by the American Cancer Society and cover common issues related to breast cancer, various treatments, and life after treatment. Participants will be asked to read through the booklet individually.
Experimental: Social support intervention group
The intervention is a 7-week program includes educational and peer mentoring support components. The education curriculum provides information on recognizing side effects of treatment and differentiating them from symptoms of cancer recurrence, physical therapy and alternative treatment, stress management, recognizing depression and managing emotional problems, communication with family members, and body image. The peer-support component assigns each participant with a mentor who is a breast cancer survivor. They share their own experience with participants and also make weekly phone calls to mentees during the intervention to provide support and address remaining concerns.
Behavioral: Social support intervention
The social support intervention is a 7-week program includes educational and peer mentoring support components. The education curriculum provides information on recognizing side effects of treatment and differentiating them from symptoms of cancer recurrence, physical therapy and alternative treatment, stress management, recognizing depression and managing emotional problems, communication with family members, and body image. The peer-support component assigns each participant with a mentor who is a breast cancer survivor. They share their own experience with participants and also make weekly phone calls to mentees during the intervention to provide support and address remaining concerns.
Other Name: JLA

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02946697

Contacts
Contact: Qian Lu, PhD; MD 713-743-8515 qlu3@uh.edu

Locations
United States, California
Herald Cancer Association Recruiting
Los Angeles, California, United States, 91776
Contact: Alice Loh    626-286-2600      
Contact: Lucy Young    626-286-2600 ext x13    lucy@cchc.org   
Sponsors and Collaborators
University of Houston
University of California, Los Angeles
Herald Cancer Association
National Cancer Institute (NCI)
Investigators
Principal Investigator: Qian Lu, PhD; MD University of Houston
  More Information

Responsible Party: Qian Lu, Associate Professor, University of Houston
ClinicalTrials.gov Identifier: NCT02946697     History of Changes
Other Study ID Numbers: 1R01CA180896 ( US NIH Grant/Contract Award Number )
R01CA180896 ( US NIH Grant/Contract Award Number )
Study First Received: October 25, 2016
Last Updated: November 3, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Houston:
Chinese
cancer survivors
Quality of Life
Social Support

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 24, 2017