Cancer
Conditions
Keywords
Behavioral research, Social research, Spirituality, Late stage cancer
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.
Interventions
BEHAVIORALFaith-Based African American Cancer Survivorship Storytelling Intervention
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
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) Score | Baseline, Week 3 post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Supportive Family Relationships (Mutuality) Scale Score | Baseline, Week 3 post-intervention | 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. |
Countries
United States
Participant flow
Pre-assignment details
Total enrollment number represents the number of individual participants including African American Cancer patients and Family caregivers.
Participants by arm
| Arm | Count |
|---|---|
| African American Cancer Patients 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.
Faith-Based African American Cancer Survivorship Storytelling Intervention: 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 | 17 |
| Family Caregivers 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.
Faith-Based African American Cancer Survivorship Storytelling Intervention: 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 | 5 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | African American Cancer Patients | Total | Family Caregivers |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 15.8 | 54.27 years STANDARD_DEVIATION 15.78 | 46.4 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 22 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 22 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 17 participants | 22 participants | 5 participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 5 |
| other Total, other adverse events | 0 / 17 | 0 / 5 |
| serious Total, serious adverse events | 0 / 17 | 0 / 5 |
Outcome results
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.
Time frame: Baseline, Week 3 post-intervention
Population: Number of participants analyzed include participants that completed the Hospital Anxiety and Depression Scale (HADS) in the study sessions for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| African American Cancer Patients and Family Caregivers | Hospital Anxiety and Depression Scale (HADS) Score | Baseline | 3.86 score on a scale | Standard Deviation 2.53 |
| African American Cancer Patients and Family Caregivers | Hospital Anxiety and Depression Scale (HADS) Score | Week 3 post-intervention | 3.40 score on a scale | Standard Deviation 3.22 |
| Family Caregivers | Hospital Anxiety and Depression Scale (HADS) Score | Baseline | 0.60 score on a scale | Standard Deviation 0.54 |
| Family Caregivers | Hospital Anxiety and Depression Scale (HADS) Score | Week 3 post-intervention | 1.20 score on a scale | Standard Deviation 1.3 |
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.
Time frame: Baseline, Week 3 post-intervention
Population: Number of participants analyzed include participants that completed the Supportive Family Relationships (Mutuality) Scale in the study sessions for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| African American Cancer Patients and Family Caregivers | Supportive Family Relationships (Mutuality) Scale Score | Baseline | 3.53 score on a scale | Standard Deviation 0.46 |
| African American Cancer Patients and Family Caregivers | Supportive Family Relationships (Mutuality) Scale Score | Week 3 post-intervention | 3.48 score on a scale | Standard Deviation 0.41 |
| Family Caregivers | Supportive Family Relationships (Mutuality) Scale Score | Baseline | 3.34 score on a scale | Standard Deviation 0.82 |
| Family Caregivers | Supportive Family Relationships (Mutuality) Scale Score | Week 3 post-intervention | 3.50 score on a scale | Standard Deviation 0.53 |