Faith-Based African American Cancer Survivorship Storytelling

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
This study addresses a need to integrate spirituality with cancer care as requested among African Americans. In the PI's research with African Americans, a dominant mental health promoting strategy used in response to a cancer diagnosis is the use of religious stories and songs. African Americans have a strong cultural history of relying on religious stories and songs to overcome oppression and mental suffering encountered in their lived experience. If successful, the findings from this preliminary study will contribute to the evidence that spirituality is important to cancer care and to achieving optimal patient outcomes among this medically underserved population. More importantly, the infusion of spirituality in cancer care has to potential to reduce the high levels of psychological distress experienced among African Americans and FCG's; to enable them to become more engaged in their cancer care and in supportive family relationships; and, ultimately to improve the overall quality of life for African American cancer patients and FCGs. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period. The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn.

Official Title
-----------------
Faith-Based African American Cancer Survivorship Storytelling: A Culturally Relevant Intervention to Alleviate Psychological Stress

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Faith-Based African American Cancer Survivorship Storytelling Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: African American cancer patients<br>Patients will be required to participate in intervention activities and 5 data collection interviews. Interviews to complete both open-ended interviews and quantitative measures will take approximately 45 minutes. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period. | Behavioral: Faith-Based African American Cancer Survivorship Storytelling Intervention<br>* The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research<br>* Other names: Hymns Intervention;|
| Experimental: Family caregivers<br>Family caregivers will be required to participate in intervention activities and 5 data collection interviews. Interviews to complete both open-ended interviews and quantitative measures will take approximately 45 minutes. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period. | Behavioral: Faith-Based African American Cancer Survivorship Storytelling Intervention<br>* The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research<br>* Other names: Hymns Intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavioral research, Social research, Spirituality, Late stage cancer