Quality of Life Clinical Trial
Official title:
An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life Among Hispanic Women Completing Active Treatment for Breast Cancer
Verified date | November 2022 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the effects of a developed psychosocial eHealth intervention on the proposed primary outcomes, health-related quality of life and symptom burden, among Hispanic breast cancer patients. The intervention components include breast cancer knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over a 12-week period. Participants are randomized into either an intervention application (described below) or standard treatment. Aside from using the Smartphone application for the recommended 12 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 12-week follow-up.
Status | Completed |
Enrollment | 51 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Female - Diagnosis of breast cancer, non-metastatic, stage 0-IIIA; for women diagnosed with stage 0, either radiation or chemotherapy is required as an additional treatment to surgery - Currently undergoing cancer treatment [e.g., surgery, chemotherapy, radiation, or combination of the two or three] - at least 21 years of age - Able to speak and read English or Spanish - Able to provide informed consent - Elevated score on breast cancer symptom burden and HRQoL, measured by the Functional Assessment of Cancer Therapy-Breast questionnaire using an established cut-off score for clinically meaningful, compromised HRQoL - Self-identified Hispanic/Latina ethnicity. Exclusion Criteria: - Visual, hearing, voice, or motor impairment that would prevent completion of study procedures - diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia) - Illicit substance or alcohol dependence - Suicidal ideation, plan, intent - Alzheimer's, dementia or history of stroke - Scheduled reconstruction surgery within 1 month of any study procedures or involvement. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B) | The FACT-B has been used extensively to measure HRQoL, and has been translated to and validated in Spanish. The FACT-B assesses participant's wellbeing in physical, emotional, social, functional, and breast cancer related concerns in the last seven days using a five-point response scale. | HRQoL will be first assessed at baseline (T1), initial HRQoL changes will be assessed at 6 weeks post-baseline (T2), and finally any additional HRQoL changes will be captured 12 weeks post-baseline (T3) | |
Primary | Symptom Burden will be evaluated with The Breast Cancer Prevention Trial symptom questionnaire (BCPT) | The BCPT measures participants' symptom burden. The BCPT asks participants to report their level of discomfort with 25 breast cancer related symptoms during the past four weeks using a five-point response scale. | Symptom Burden will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3) | |
Secondary | Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES) | The IES is made up of two subscales measuring the frequency of intrusion and avoidance experiences after a stressful event. The IES has been widely used among patients diagnosed with cancer and has been translated and validated with Spanish-speaking participants. | Cancer-specific distress will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3) | |
Secondary | Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire | This questionnaire has been tested with Spanish-speaking Hispanic breast cancer survivors, it is made up of 16 true and false questions regarding general breast cancer knowledge. | Breast Cancer Knowledge will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3) | |
Secondary | Breast Cancer Related Communication and Attitudinal Self-Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer) | The CASE-cancer questionnaire is made up various subscales measuring breast cancer related communication and attitudinal self-efficacy. Each question asks participants to use a four-point response scale to agree or disagree with statements regarding their level of confidence with different skills. | Breast Cancer Related Communication and Attitudinal Self-Efficacy will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3) | |
Secondary | Stress Management Skills will be evaluated with the Brief COPE Inventory | The Brief COPE is made up of various subscales measuring different ways of coping. Each question as participants to rate how often they have used each coping mechanism in response to their breast cancer experience. | Stress Management Skills will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3) |
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