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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03880526
Other study ID # IRB00056939
Secondary ID WFBCCC 04219P30C
Status Completed
Phase
First received
Last updated
Start date February 3, 2020
Est. completion date March 11, 2021

Study information

Verified date June 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this proposed study is to enhance the investigators understanding of the comprehensive psychosocial and medical needs of rural cancer patients and survivors along the cancer continuum, ultimately allowing us to address these gaps by identifying areas of support that can be bolstered by a population health navigator focused on rural populations.


Description:

Primary objectives To enhance understanding of the comprehensive psychosocial and medical needs of cancer survivors and caregivers in rural northwest North Carolina, focusing on their health needs, psychosocial concerns, perceived needs related to cancer and survivorship care, access/barriers to care, and knowledge/perceptions of clinical research using focus groups and semi-structured interviews. This aim is hypothesis-generating. To document rural cancer patient/survivors' reports of: a) health behaviors; b) psychosocial needs; c) current health-related information and supportive care needs; d) barriers to care; e) symptoms and health-related quality of life using a quantitative survey


Recruitment information / eligibility

Status Completed
Enrollment 503
Est. completion date March 11, 2021
Est. primary completion date March 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cancer diagnosis (other than non-melanoma skin cancer) and > 6 months post-definitive treatment (e.g., surgery, chemotherapy, and/or radiation); Survivors on ongoing systemic maintenance therapies (e.g., hormonal therapies and immunotherapies) are eligible - Currently residing in one of the 6 priority counties in northwest North Carolina (Alleghany, Ashe, Avery, Mitchell, Stokes, Surry, Watauga, or Wilkes) or in a rural area in North Carolina as defined by a rural-urban commuting area (RUCA) code of 4-10. - Ability and willingness to attend a one-time focus group or interview and/or complete a one-time study survey - Age greater than 18 years. Providers: - Healthcare provider (e.g. primary care, oncology or other specialty, allied health) with knowledge of the needs of adult cancer survivors who are currently working in one of the priority counties in Northwest North Carolina (Alleghany, Ashe, Avery, Mitchell, Stokes, Surry, Watauga, or Wilkes) - Ability and willingness to attend a one-time interview Exclusion Criteria: - Those who are unable to read and understand English, as the study interviews/focus groups and survey will be conducted in English - Unwilling to participate in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improving Cancer-Related Experiences Through Interviews or Focus Group Settings Through focus groups or interviews information will be collected on participants' experience receiving cancer-related care and to ask for specific suggestions and ways to improve care and cancer-related resources for adults living in a rural area. 90 minutes
Primary Measurement of Quality of Life The PROMIS Global 10 survey will be used to document rural cancer patient/survivors' reports of: a) health behaviors; b) psychosocial needs; c) current health-related information and supportive care needs; d) barriers to care; e) symptoms and health-related quality of life using a quantitative survey. Survey scoring consists of 5=Never, 4=Rarely, 3=Sometimes, 2=Often and 1=Always. 90 minutes
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