CancerNCT03082612
Faith-Based African American Cancer Survivorship Storytelling
A study testing Faith-Based African American Cancer Survivorship Storytelling Intervention in people with Cancer, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cancer
- What is being tested?
- Faith-Based African American Cancer Survivorship Storytelling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
- Find conversations around religion or spirituality emotionally upsetting
Trial locations and contacts
1 site in 1 country.
United States1 site
Grady Cancer Center for Excellence
Atlanta, Georgia, 30303
About this study
Official title: Faith-Based African American Cancer Survivorship Storytelling: A Culturally Relevant Intervention to Alleviate Psychological Stress
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Faith-Based African American Cancer Survivorship Storytelling Intervention
- Keywords
- Behavioral research, Social research, Spirituality, Late stage cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faith-Based African American Cancer Survivorship Storytelling InterventionBehavioural
Also called Hymns 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
| Study group | Role | What they receive |
|---|---|---|
| African American cancer patients | Experimental | 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. Receives: Behavioral: Faith-Based African American Cancer Survivorship Storytelling Intervention |
| Family caregivers | Experimental | 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. Receives: Behavioral: Faith-Based African American Cancer Survivorship Storytelling Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 3 post-intervention
Secondary outcomes (1)
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.
Measured: Baseline, Week 3 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start28 Jun 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jill Hamilton, Emory University
- Investigators
- Jill B Hamilton, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082612
- Sponsor's protocol ID
- IRB00093110
- Other IDs
- 5R03MD013509-02
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2017
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faith-Based African American Cancer Survivorship Storytelling: A Culturally Relevant Intervention to Alleviate Psychological Stress
- ClinicalTrials.gov ID
- NCT03082612
- Acronym / sponsor ID
- IRB00093110
- Conditions
- Cancer
- Keywords
- Behavioral research, Social research, Spirituality, Late stage cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African American cancer patients | Experimental | Behavioral: Faith-Based African American Cancer Survivorship Storytelling InterventionPatients 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. |
| Family caregivers | Experimental | Behavioral: Faith-Based African American Cancer Survivorship Storytelling InterventionFamily 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Faith-Based African American Cancer Survivorship Storytelling InterventionAlso: Hymns InterventionThe 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 | Behavioural | African American cancer patients, Family caregivers |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) Score
Time frame: 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.
1 secondary outcome
Supportive Family Relationships (Mutuality) Scale Score
Time frame: Baseline, Week 3 post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Jill B Hamilton, PhD, RN principal investigator
Emory 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 Faith-Based African American Cancer Survivorship Storytelling Intervention in people with Cancer, run by Emory 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 5 Oct 2023. 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. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) Score (time frame: Baseline, Week 3 post-intervention). 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 5 Oct 2023.