CancerRSVPNCT03880526
Rural Survivorship Navigation Program
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 503 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 11 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Rural Survivorship naVigation Program (RSVP): Building Community Capacity for Cancer Control
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.
Read the 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
- Conditions
- Cancer
- Keywords
- Cancer prevention control, Cancer navigation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
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.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start3 Feb 2020
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Weaver, MPH, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880526
- Sponsor's protocol ID
- IRB00056939
- Other IDs
- WFBCCC 04219, P30CA012197, NCI-2019-01751
- Acronym
- RSVP
- Status last verified
- Jun 2021
- First submitted
- 13 Mar 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Survivorship naVigation Program (RSVP): Building Community Capacity for Cancer Control
- ClinicalTrials.gov ID
- NCT03880526
- Acronym / sponsor ID
- RSVP / IRB00056939
- Conditions
- Cancer
- Keywords
- Cancer prevention control, Cancer navigation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Weaver, MPH, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving Cancer-Related Experiences Through Interviews or Focus Group Settings (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021; AzTrials last refreshed its copy on 29 Oct 2026.