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Protocols

Protocols -    

Title of Study:  
Principal Investigator(s) of the Research Study:

Edward Partridge, MD

Specific aims


There is ample literature suggesting that cancer patients rely on religiosity/spirituality (RS) to cope with their disease.1-9 This is particularly the case for African Americans.10-14 However, yet to be determined is how, or which aspects of RS mediate cancer coping and quality of life. Because both religiosity and spirituality are multifactorial,15-18 it is possible that some factors are important in cancer coping and others are less important. Some studies have begun to explore the ways in which people use RS to cope with life events19, Alzheimer’s caregiving,20 and the role of RS in cancer.21-26 However, a more thorough and systematic approach is needed, looking specifically at how African Americans use RS in cancer coping, in other words the mediators of the RS-coping relationship. This approach needs to be followed up with validated instrumentation, and a quantitative examination of which mediators are associated with adaptive as well as maladaptive coping. Just as there are multiple channels proposed by which RS impacts one's health (e.g., stress reduction, sense of meaning), there are likely multiple mediators of RS and cancer coping and survivorship. If these mediators could be identified and operationalized, they could be capitalized upon in cancer support groups and coping interventions. This is particularly important to examine among African Americans because on average they tend to be high in RS27-33 and suffer disproportionately from cancer disparities.34 The proposed study will explore mediators of RS and cancer coping among African Americans, through a UAB/MSM partnership where data will be collected from both sites in equal proportions. This study is unique in that while other studies are beginning to explore the role of RS in cancer,21-26 these studies do not focus on African Americans and the work does not extend beyond the qualitative phase.

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Specifically, this study will:

Spirituality             

1. Explore the role of spirituality/religiosity in cancer coping, in other words mediators of the association between RS and cancer coping (RSCC mediators), and quality of life. This will be done through 30 semi-structured interviews with African American cancer patients. The interview data will be analyzed using open coding methods and themes/patterns will be developed and validated through the development of a codebook, inter-rater reliability, and member checking. This will result in a set of RSCC mediators among African Americans.

 

 

POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS:


Although we consider the aforementioned risks to be generally mild and unlikely, we will take steps to reduce their occurrence. We believe there are benefits associated with talking about one’s experience with cancer and how one was able to cope.

IMPORTANCE OF THE KNOWLEDGE TO BE GAINED

By understanding the role of RS in cancer coping in African Americans, we will be able to develop more effective support groups and interventions with this population. This may ultimately reduce the cancer burden in African Americans and promote more effective coping in other domains. The minimal risks described above are warranted in light of these benefits.

Inclusion of women in clinical research

Half of the 310 study participants will be women. Participants will be enrolled in the study in the first, second, and third years of the study and their participation will be complete after the initial study session. The exception is the 50 participants involved in the psychometric testing of the instruments in Phase 2, who will be interviewed once and again two weeks later.

 

Inclusion of minorities in clinical research

Given the resources required to determine how the RSCC mediators relate to cancer coping among specific to racial groups, it is beyond the scope of this project to include multiple racial groups in the study sample. A multi-culture approach and study sample would effectively double (or more) project sample size and costs. Therefore, the study will only enroll African Americans. The burden of cancer for African Americans is substantially greater than that of Whites. Participants will be enrolled in the study in the first, second, and third years and their participation will be complete after the initial study session. The exception is the 50 participants involved in the psychometric testing of the instruments in Phase 2, who will be interviewed once and again two weeks later.

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Clinical Research Center at Morehouse School of Medicine
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