Breast CancerNCT03413332
Web-Based Communication Education for Breast Cancer Survivorship Care
A study testing E-Talkcare in people with Breast Cancer, run by Georgetown University at 1 site in United States.
Trial summary
This two-phase research plan will develop and test a culturally relevant, web-based patient education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese cancer patients to effectively communicate with different providers in different healthcare settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- E-Talkcare
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 31 Mar 2022
- 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
- Eligible Chinese women
- ≥ age 18
- foreign-born speaking Mandarin and/or Cantonese,
- diagnosed with breast cancer at stage 0, I, II or III,
- 1-3 years post-diagnosis and completed primary treatment (surgery, radiation, and chemotherapy); and
- no recurrence, and 6) internet access.
Who cannot join
- Women with other cancer types are ineligible due to different treatment complications.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
Judy Wang, PhD, 202-687-6306, jw235@georgetown.edu
Judy (Huei_Yu) Wang, Ph.D.
About this study
This two-phase research plan will develop and test a culturally relevant, web-based patient education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese cancer patients to effectively communicate with different providers in different healthcare settings.
Read the detailed description
This two-phase study develops and tests the usability and efficacy of a culturally relevant, web-based patient education program, hereafter known as E-Talkcare, in improving Chinese immigrant breast cancer survivors' competence, perceived control, and self-efficacy in cancer care communication (intermediate outcomes), and patient-reported symptoms, adherence to breast cancer survivorship care guidelines, and quality of life (distal outcomes) versus the usual care control arm. In Phase I, community-based participatory research (CBPR) principles will be used to develop the intervention to educate participants about culture and communication by demonstrating how to ask for and verify information with doctors and use personalized symptom reports, and by providing question prompt lists for doctor visits. In Phase II, the intervention will be tested in a pilot randomized control trial (RCT). Using cases from Los Angeles Cancer Surveillance Program, California Cancer Registry, Maryland Cancer Registry, and clinics from California, 118 Chinese immigrant women (diagnosed with stage 0-III breast cancer and 1-3 years post-diagnosis) will be enrolled and randomized to either the E-Talkcare intervention or a usual care control arm. Participants will be interviewed via telephone at baseline (i.e., pre-randomization), 3-, and 6-months post-randomization.
- Conditions
- Breast Cancer
- Being tested
- E-Talkcare, Usual Care
- Keywords
- Chinese American Women, Provider-patient Communication, Survivorship Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-TalkcareOther
Women in the intervention group will receive the E-Talkcare web address, a user name, and a temporary password. The participant will be able to read or listen (through audio narration) to instructions on how to complete the intervention in order, though she can freely navigate between web modules. Each module will have an ever-present indicator (showing users' progress) and a link to for users to continue navigating through modules.We will ask participants to complete the full intervention within 3 months after intervention delivery and then complete a 3-month post-randomization interview (T1). The website will remain open for six months after intervention delivery to allow participants to use QPL if they wish. A 6-month post-randomization interview (T2) will then be administered.
Usual CareOther
Survivors randomized to the usual care group will receive care from their doctors as usual, allowing us to compare the intervention against real-world practice to inform next steps. Since we do not know if the intervention will be efficacious, we decided not to provide a delayed intervention to control participants.
| Study group | Role | What they receive |
|---|---|---|
| E-Talkcare Group | Experimental | use the web-based patient education tool Receives: Other: E-Talkcare |
| Usual Care Group | Placebo comparator | receive usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Communication Competence Scale
16 items to assess information provision, seeking, and verifying; α=.80-.89.
Measured: 6 months
Assessment of Patient Experiences of Cancer Care
10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese
Measured: 6 months
Decision-making Participation Self-efficacy Scale
5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese
Measured: 6 months
Perceived Personal Control Scale
4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese
Measured: 6 months
Secondary outcomes (9)
PROMIS Fatigue
6 items (e.g., felt tired, exhausted, limited at work); α=.97
Measured: 6 months
PROMIS Sleep Disturbance
6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98
Measured: 6 months
PROMIS Pain Interference
6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95
Measured: 6 months
PROMIS Cognitive Function
6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95
Measured: 6 months
PROMIS Physical Function
8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90
Measured: 6 months
PROMIS Anxiety
7 items (e.g., felt anxious, nervous, fearful, tense); α=.90
Measured: 6 months
PROMIS Depression
8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90
Measured: 6 months
Side/late Effect Assessments
31-item measure of patient-reported side/late effects from breast cancer treatment
Measured: 6 months
Adherence to Breast Care Guidelines
26 yes-no items: receiving breast cancer follow-up care recommendations from doctors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Apr 2017
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy Wang, Georgetown University
- Investigators
- Judy Wang, Ph.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413332
- Sponsor's protocol ID
- 2016-1407
- Status last verified
- Feb 2021
- First submitted
- 5 Jan 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Communication Education for Breast Cancer Survivorship Care
- ClinicalTrials.gov ID
- NCT03413332
- Acronym / sponsor ID
- 2016-1407
- Conditions
- Breast Cancer
- Keywords
- Chinese American Women, Provider-patient Communication, Survivorship Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 29 Jan 2018 (actual)
- 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 two-phase research plan will develop and test a culturally relevant, web-based patient education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese cancer patients to effectively communicate with different providers in different healthcare settings.
Detailed description
This two-phase study develops and tests the usability and efficacy of a culturally relevant, web-based patient education program, hereafter known as E-Talkcare, in improving Chinese immigrant breast cancer survivors' competence, perceived control, and self-efficacy in cancer care communication (intermediate outcomes), and patient-reported symptoms, adherence to breast cancer survivorship care guidelines, and quality of life (distal outcomes) versus the usual care control arm. In Phase I, community-based participatory research (CBPR) principles will be used to develop the intervention to educate participants about culture and communication by demonstrating how to ask for and verify information with doctors and use personalized symptom reports, and by providing question prompt lists for doctor visits. In Phase II, the intervention will be tested in a pilot randomized control trial (RCT). Using cases from Los Angeles Cancer Surveillance Program, California Cancer Registry, Maryland Cancer Registry, and clinics from California, 118 Chinese immigrant women (diagnosed with stage 0-III breast cancer and 1-3 years post-diagnosis) will be enrolled and randomized to either the E-Talkcare intervention or a usual care control arm. Participants will be interviewed via telephone at baseline (i.e., pre-randomization), 3-, and 6-months post-randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Talkcare Group | Experimental | Other: E-Talkcareuse the web-based patient education tool |
| Usual Care Group | Placebo comparator | Other: Usual Carereceive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible Chinese women
- ≥ age 18
- foreign-born speaking Mandarin and/or Cantonese,
- diagnosed with breast cancer at stage 0, I, II or III,
- 1-3 years post-diagnosis and completed primary treatment (surgery, radiation, and chemotherapy); and
Key exclusion criteria (1 listed)
- Women with other cancer types are ineligible due to different treatment complications.
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 |
|---|---|---|
| E-TalkcareWomen in the intervention group will receive the E-Talkcare web address, a user name, and a temporary password. The participant will be able to read or listen (through audio narration) to instructions on how to complete the intervention in order, though she can freely navigate between web modules. Each module will have an ever-present indicator (showing users' progress) and a link to for users to continue navigating through modules.We will ask participants to complete the full intervention within 3 months after intervention delivery and then complete a 3-month post-randomization interview (T1). The website will remain open for six months after intervention delivery to allow participants to use QPL if they wish. A 6-month post-randomization interview (T2) will then be administered. | Other | E-Talkcare Group |
| Usual CareSurvivors randomized to the usual care group will receive care from their doctors as usual, allowing us to compare the intervention against real-world practice to inform next steps. Since we do not know if the intervention will be efficacious, we decided not to provide a delayed intervention to control participants. | Other | Usual Care Group |
Primary outcome
Medical Communication Competence Scale
Time frame: 6 months
16 items to assess information provision, seeking, and verifying; α=.80-.89.
Assessment of Patient Experiences of Cancer Care
Time frame: 6 months
10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese
Decision-making Participation Self-efficacy Scale
Time frame: 6 months
5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese
Perceived Personal Control Scale
Time frame: 6 months
4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese
9 secondary outcomes
PROMIS Fatigue
Time frame: 6 months
PROMIS Sleep Disturbance
Time frame: 6 months
PROMIS Pain Interference
Time frame: 6 months
PROMIS Cognitive Function
Time frame: 6 months
PROMIS Physical Function
Time frame: 6 months
PROMIS Anxiety
Time frame: 6 months
PROMIS Depression
Time frame: 6 months
Side/late Effect Assessments
Time frame: 6 months
Adherence to Breast Care Guidelines
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Judy Wang, Ph.D. principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Talkcare in people with Breast Cancer, run by Georgetown University 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judy Wang, Ph.D. (202-687-6306, jw235@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Communication Competence Scale (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021.