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NCT Number: NCT02946697

A Culturally Sensitive Social Support Intervention

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Herald Cancer Association

Los Angeles, California, 91776, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social support intervention

Behavioral

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 names: JLA

Primary outcomes

  1. Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)

    Time frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention

Secondary outcomes

  1. 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).

  2. Change in positive affect as assessed by the PANAS

    Time frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention

  3. 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.

  4. 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

Other outcomes

  1. Change in cortisol slope

    Time frame: Baseline before intervention and immediately

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Herald Cancer Association
  • National Cancer Institute (NCI)
  • University of California, Los Angeles

Registry information

Acronym: JLA

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2016
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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