NCT03082612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 5, 2023

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

March 14, 2017

Results QC Date

June 16, 2023

Last Update Submit

September 11, 2023

Conditions

Keywords

Behavioral researchSocial researchSpiritualityLate stage cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Supportive Family Relationships (Mutuality) Scale Score

    Baseline, Week 3 post-intervention

Study Arms (2)

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.

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.

Behavioral: Faith-Based African American Cancer Survivorship Storytelling Intervention

Interventions

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

Also known as: Hymns Intervention
African American cancer patientsFamily caregivers

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Immediate or extended family member of the patient
  • years of age or older
  • Able to provide informed consent
  • Willing to participate in study activities, including data collection
  • Find conversations around religion or spirituality emotionally upsetting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Cancer Center for Excellence

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr. Jill Hamilton
Organization
Emory University

Study Officials

  • Jill B Hamilton, PhD, RN

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 17, 2017

Study Start

June 28, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

October 5, 2023

Results First Posted

October 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations