Cancer Clinical Trial
Official title:
Faith-Based African American Cancer Survivorship Storytelling: A Culturally Relevant Intervention to Alleviate Psychological Stress
Verified date | September 2023 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to evaluate the feasibility and acceptability of an intervention (viewing of video recordings) designed to reduce psychological distress among African Americans during treatment for cancer. This knowledge will inform a larger test of an intervention.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria for Patients: - Age 30-89 years - Newly diagnosed with any stage cancer - Treatment plans to include weekly outpatient chemotherapy - Previously screened and with greater than 0 level of psychological distress - Willingness to participate in all study activities including data collection - Willing to identify a family caregiver (FCG) (immediate or extended family member) to also participate Exclusion Criteria for Patients: - Have completed surgery with no plans for chemotherapy - Find conversations around religion or spirituality emotionally upsetting - Have completed more than half of prescribed chemotherapy treatments - In hospice care - Not able to provide informed consent Inclusion Criteria for Family Caregiver: - Immediate or extended family member of the patient - 18 years of age or older - Able to provide informed consent - Willing to participate in study activities, including data collection Exclusion Criteria for Family Caregiver: - Find conversations around religion or spirituality emotionally upsetting |
Country | Name | City | State |
---|---|---|---|
United States | Grady Cancer Center for Excellence | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital Anxiety and Depression Scale (HADS) Score | Psychological distress for patients and family caregivers (FCGs) will be measured with the Hospital Anxiety and Depression Scale (HADS). Scoring for the Anxiety and Depression scale of the HADS is (0-21); Normal (0-7); Borderline Abnormal Case (8-10); and Abnormal Case (11-21). Higher score correlates with worse outcome. |
Baseline, Week 3 post-intervention | |
Secondary | Supportive Family Relationships (Mutuality) Scale Score | Mutuality is measured with the scale "You, Your Family and Friends" that measures the degree of positive relationships among participants and their family and friends. This scale measures the degree to which the caregiver-care receiver relationship was characterized by love, shared values, shared pleasurable activities, and reciprocity. The adapted scale has 12-items with a 5-point response format. A mean of responses with a range of 0 to 5 will be reported. Higher scores are indicative of better outcomes, indicating engagement in positive supportive relationships with family and friends. | Baseline, Week 3 post-intervention |
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