Breast CancerJLANCT02946697
A Culturally Sensitive Social Support Intervention
A study testing Social support intervention in people with Breast Cancer and Breast Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Social support intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 14 Oct 2024
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to read or speak Chinese (Mandarin or Cantonese)
- breast cancer diagnosis of stage IV
- live outside of the LA area
Trial locations and contacts
1 site in 1 country.
United States1 site
Herald Cancer Association
Los Angeles, California, 91776
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Social support intervention
- Keywords
- Chinese, cancer survivors, Quality of Life, Social Support
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social support interventionBehavioural
Also called JLA
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced care and wait-list control group | No intervention | 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. |
| Social support intervention group | Experimental | 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. Receives: Behavioral: Social support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)
Measured: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Secondary outcomes (4)
Change in depressive symptoms as assessed by CES-D
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).
Measured: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Change in positive affect as assessed by the PANAS
Measured: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Change in fatigue as assessed by FACIT
A short-version (i.e. 6-item) of Functional Assessment of Chronic Illness Therapy-Fatigue scale was used.
Measured: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Change in stress as assessed by the Perceived stress scale (PSS)
Measured: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJan 2015
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Herald Cancer Association, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Qian Lu, PhD; MD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946697
- Sponsor's protocol ID
- PA18-0280
- Other IDs
- R01CA180896, 16402-02
- Acronym
- JLA
- Status last verified
- Feb 2024
- First submitted
- 25 Oct 2016
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34550088
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Sensitive Social Support Intervention
- ClinicalTrials.gov ID
- NCT02946697
- Acronym / sponsor ID
- JLA / PA18-0280
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Chinese, cancer survivors, Quality of Life, Social Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Herald Cancer Association, National Cancer Institute (NCI)
- Study start
- Jan 2015 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 27 Oct 2016 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced care and wait-list control group | No intervention | –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. |
| Social support intervention group | Experimental | Behavioral: Social support interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- unable to read or speak Chinese (Mandarin or Cantonese)
- breast cancer diagnosis of stage IV
- live outside of the LA area
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 |
|---|---|---|
| Social support interventionAlso: JLAThe 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. | Behavioural | Social support intervention group |
Primary outcome
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
4 secondary outcomes
Change in depressive symptoms as assessed by CES-D
Time frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 34550088Lu 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.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Qian Lu, PhD; MD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social support intervention in people with Breast Cancer and Breast Neoplasms, run by M.D. Anderson 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 3 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: finished, as of the sponsor's last update on 16 Oct 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946697, which also lists 1 linked publication.
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 16 Oct 2024.