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Overcoming Psychological Distress Through Hymns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03082612
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : March 17, 2017
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jill Hamilton, Emory University

Tracking Information
First Submitted Date  ICMJE March 14, 2017
First Posted Date  ICMJE March 17, 2017
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE June 28, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
Change in Hospital Anxiety and Depression Scale (HADS) score [ Time Frame: Baseline, Week 3 ]
Psychological distress for patients and family caregivers (FCGs) will be measured with the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item self-report screening scale for anxiety and depressive states, with 7 items assessing anxiety and 7 items assessing depression. Respondents indicate the degree of anxiety or depression they are feeling on a scale of 0 to 3. Score totals for each subscale range from 0 to 21, where a score of 0-7 = "normal", 8-10 = "borderline abnormal" and 11-21 = "abnormal".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • Change in Interpersonal Processes of Care Survey (IPC-18) score [ Time Frame: Baseline, Week 3 ]
    Patient-Physician communication for patients and FCGs is measured with the Interpersonal Processes of Care Survey: Short Form (IPC-18). The IPC-18 is an 18-item questionnaire that assesses seven different aspects of physician interactions: lack of clarity, elicited concerns/responded, explained results, worked together, compassionate/respectful, discriminated due to race/ethnicity, disrespectful office staff. Sub-scale scores have a range from 1-5, and they vary in terms of interpretation (high score equals worse processes for "lack of clarity", "discriminated due to race/ethnicity", and "disrespectful staff" while a high score indicates better process for the other four sub-scales).
  • Change in Supportive Family Relationships (Mutuality) Scale score [ Time Frame: Baseline, Week 3 ]
    Relationship well-being for patients and FCGs is measured with the Supportive Family Relationships (Mutuality) Scale. The Mutuality scale measures the degree to which the caregiver-care receiver relationship is characterized by love, shared values, shared pleasurable activities, and reciprocity. The adapted scale for patients has 12-items with a 5-point (0-4) response format (total score ranges from 0 to 48). The scale for caregivers has 15 items (total score ranges from 0 to 60). Higher scores are indicative of engagement in positive supportive relationships with family and friends
  • Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP-12) score [ Time Frame: Baseline, Week 3 ]
    Spiritual well-being is measured with the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being questionnaire (FACIT-SP-12) which assesses a sense of meaning, peace, and comfort and strength derived from faith. The FACIT-SP-12 has a 5-point Likert-type scale format. Total scores range from 0 to 48 with higher scores indicating higher levels of spiritual well-being.
  • Change in Short Form-12 Health Survey Questionnaire (SF-12) score [ Time Frame: Baseline, Week 3 ]
    The Short Form-12 Health Survey Questionnaire (SF-12) (version 2) is a measure of general physical and mental health. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. The total score for each subscale ranges from 0 to 100 and low values represent a poor health state while high values represent a good health state.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Overcoming Psychological Distress Through Hymns
Official Title  ICMJE Overcoming Psychological Distress Through Hymns Intervention Among Late Stage African American Cancer Patients and Their FCGs
Brief Summary The purpose of this study is to evaluate the feasibility and acceptability of an intervention designed to reduce psychological distress among African Americans during treatment for cancer. This knowledge will inform a larger test of an intervention tailored to decrease the psychological distress experienced among African Americans diagnosed with late-stage cancers. Study participants will take part in 4 data collection sessions and also asked to view and provide feedback on audio- or video recorded vignettes of African Americans use of hymns to reduce psychological distress during the diagnosis and treatment for cancer. Participants will also be asked to complete interviews at the 4 time periods which will include open-ended, semi-structured interviews, and structured interview questions. This study addresses the need to understand the ways in which narrated messages of hope through hymns and African American religious song in particular, reduce psychological distress.
Detailed Description

African Americans have a strong cultural history of relying on hymns to overcome oppression and mental suffering encountered in their lived experience. This study will evaluate the feasibility and acceptability of an intervention using hymns in reducing psychological distress among African Americans during treatment for cancer. Study participants will take part in 4 data collection sessions and also asked to view and provide feedback on audio- or video recorded vignettes of African Americans use of hymns to reduce psychological distress during the diagnosis and treatment for cancer. The findings from this preliminary study will contribute to the body of research about incorporating spirituality in cancer care to achieving optimal patient outcomes.

This feasibility study uses a randomized control design and qualitative methods to: 1) determine feasibility and acceptability, and 2) estimate effect sizes for outcomes of psychological distress, spiritual well-being, patient-physician communication, supportive family relationships, and quality of life. African American patients with late stage cancer and their FCGs will be randomized to receive the Overcoming Psychological Distress through Hymns Intervention or usual care for 3 weeks. At the end of the intervention period, the usual care study arm usual will receive the 3 week intervention. Participants will have 4 study visits where they will complete questionnaires and take part in open-ended, semi-structured interviews and structured interviews. Questions asked will focus on demographic characteristics of the sample such as age, education, whether residence is urban or rural, religious affiliation, marital status, proximity to family, type cancer, date of diagnosis, date of treatment. Structured interview questions will include measures of psychological distress, spiritual well-being, relationship well-being, patient-physician communication, and quality of life. Open ended interviews will focus on usefulness and satisfaction with the video and audio recordings. Open ended interviews will be audio-recorded. Participants will be in the study for 12 weeks to complete all follow up visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participant dyads (patient and family care giver) will be randomized to receive the intervention or usual care (control arm) for 3 weeks. After the Week 3 data collection, the control arm will receive intervention. Both groups will have follow up data collected at Week 6 and Week 12.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cancer
Intervention  ICMJE
  • Behavioral: Overcoming Psychological Distress through 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
  • Behavioral: Usual care
    Usual care includes education to increase cancer knowledge, treatment coaches, and psychological services.
Study Arms  ICMJE
  • Experimental: Intervention plus usual care
    Participants (patients and their family caregivers) in this study arm will receive the Overcoming Psychological Distress through Hymns Intervention.
    Interventions:
    • Behavioral: Overcoming Psychological Distress through Hymns Intervention
    • Behavioral: Usual care
  • Active Comparator: Usual care
    Immediately after randomization and completion of baseline measures, participants in this study arm will receive usual care. Patients and their family caregivers will receive the Overcoming Psychological Distress through Hymns Intervention after the 3 week period of usual care.
    Intervention: Behavioral: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: June 22, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2017)
40
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Patients:

  • Age 50-89 years
  • Newly diagnosed with a stage 3 or 4 cancer
  • Treatment plans to include weekly outpatient chemotherapy
  • Previously screened and with any 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03082612
Other Study ID Numbers  ICMJE IRB00093110
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jill Hamilton, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jill B Hamilton, PhD, RN Emory University
PRS Account Emory University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP