Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 1366 for:    rural

Rural Survivorship Navigation Program (RSVP)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880526
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease
Cancer

Detailed 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


Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rural Survivorship naVigation Program (RSVP): Building Community Capacity for Cancer Control
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Group/Cohort
Semi-Structured Interview
Participants will choose to participant in an individual in-depth interview to be conducted by investigators to gain information about the participant's background, cancer status and treatment.
Focus Groups
Participants may choose to participate in one of three focus groups of no more than 10 participants in each group to to gain information about the participant's background, cancer status and treatment.



Primary Outcome Measures :
  1. Improving Cancer-Related Experiences Through Interviews or Focus Group Settings [ Time Frame: 90 minutes ]
    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.

  2. Measurement of Quality of Life [ Time Frame: 90 minutes ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for this study is adult men and women of all races and ethnicities who have received a diagnosis of cancer and are residing in a rural area of Northwest North Carolina.
Criteria

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, Watauga, or Wilkes)
  • Ability and willingness to attend a one-time focus group or interview and/or complete a one-time study survey
  • Age > 18

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880526


Locations
Layout table for location information
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Study Coordinator       kmshore@wakehealth.edu   
Principal Investigator: Kathryn Weaver         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Kathryn Weaver, MPH, PhD Wake Forest University Health Sciences

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03880526     History of Changes
Other Study ID Numbers: IRB00056939
WFBCCC 04219 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Cancer prevention control
Cancer navigation