Cancer SurvivorNCT03520283
Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors
A study testing Interview, Questionnaire Administration and System Support Mapping in people with Cancer Survivor and Stage I Colorectal Cancer AJCC v8, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot trial studies how well systems support mapping works in guiding self-management in stage I-III colorectal cancer survivors. Systems support mapping helps participants to see complex self-management activities on paper, which makes them more actionable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8
- What is being tested?
- Interview, Questionnaire Administration and System Support Mapping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 6 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Diagnosed with stage I-III colorectal cancer
- Within 2 years of completing active treatment for colorectal cancer
- Cognitively able to complete interviews as judged by the study team
- Able to understand, read and write English
Who cannot join
- Declined participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors
This pilot trial studies how well systems support mapping works in guiding self-management in stage I-III colorectal cancer survivors. Systems support mapping helps participants to see complex self-management activities on paper, which makes them more actionable. Behavioral interventions, such as systems support mapping, may help colorectal cancer survivors facilitate self-awareness, create motivation for behavior change, and guide self-management.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of the systems support mapping (MAP) intervention in colorectal cancer survivors, as characterized by enrollment, intervention adherence, and retention rates.
SECONDARY OBJECTIVES:
- To evaluate intervention acceptability as characterized by participant ratings.
II. To describe outcome variability to inform future studies. III. To identify multi-level contextual factors influencing self-management (SM).
IV. To qualitatively assess feasibility, acceptability using semi-structured interviews.
- To examine how study results vary by rural-urban context.
OUTLINE:
Participants complete MAP in-clinic over 60-90 minutes.
After completion of study, participants are followed-up for up to 2 weeks.
- Conditions
- Cancer Survivor, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8
- Being tested
- Interview, Questionnaire Administration, System Support Mapping
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
System Support MappingBehavioural
Also called MAP Intervention; System Support Mapping Intervention; MAP
Complete MAP
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (MAP) | Experimental | Participants complete MAP in-clinic over 60-90 minutes. Receives: Other: Interview; Other: Questionnaire Administration; Behavioral: System Support Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
To be calculated as the percent of eligible participants approached who agree to participate. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
Measured: Up to 1 year
Participation Rate
To be calculated as the percent of participants who complete the study intervention among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Retention Rate
To be calculated as the proportion of participants who complete the study measures among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary outcomes (14)
Self-reported Ratings of Intervention Acceptability
Descriptive statistics will be used to summarize participant ratings of acceptability of intervention.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Measures of Autonomy Assessed by Index of Autonomous Functioning
Each item in the scale ranges from 0-5, where 0=not at all true and 5=completely true. Scale is a mean of these items and thus ranges from the same minimum of 0 to the same maximum of 5. A higher score represent higher degree of autonomy.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Self-efficacy for Managing Cancer - Chronic Disease Scale
Scale is a mean of physical and emotional functional management of chronic disease. Each of which runs from 1 (not at all confident) to 10 (totally confident). A higher score represents a higher degree of confidence in self-efficacy.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form
Overall score is based emotional and physical management of symptoms and is converted to a norm-based score that ranges from 0-100. Higher score means more of construct or response of managing symptoms.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection
The overall score is based on participant's relatedness to interventionists and is converted to a norm-based score that ranges from 26.6-72.5. Higher score on the HEAL measure means a higher degree of patient-provider connection as assessed by the patient.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Psychological Stress Assessed by Perceived Stress Scale
Descriptive statistics (means, standard deviations) will be used to summarize proximal outcomes and change in health outcomes by assessment measure. The primary interest will be in estimating the variance for use in planning future studies. A 4-item questionnaires to assess participants' stress during the intervention at baseline and at two weeks with a difference of both time points. Scoring scale is from 0-4 ( 0 - never and 4 - very often). Scoring range is 0-16 with the higher score indicating higher stress.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29
PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Norm-based scores have been calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population. On symptom oriented domains of PROMIS-29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function oriented domains (physical functioning and social role) higher scores represent better functioning.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Health Behaviors Assessed by Items on Tobacco Use
Descriptive statistics will be used to summarize proximal outcomes. Participants were asked questions about their health behavior related to their past or present smoking behaviors (i.e. packs per day, last time they smoked) in order to help improve upon the information received to offer support for future studies.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Qualitative Assessment of Feasibility With Semi-structured Interviews
Will conduct a qualitative content analysis. Qualitative data will be sent to an external vendor to be transcribed. Two internal study team members will double-code at least 10% of coding of transcripts from the semi-structured interviews and resolve any disagreements to ensure that robust and unbiased results are achieved. Will evaluate qualitative and quantitative analyses in a mixed-methods framework for consistency and discrepancies across all analyses to refine the protocol.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Qualitative Analysis of Systems Support Maps
The internal study team will work with collaborators through an iterative process to facilitate a qualitative content analysis of the large quantity of textual MAP data. Will examine all qualitative analyses by urban-rural status as classified using Rural Urban Commuting Area Codes. Qualitative results will be summarized by urban-rural status. Will also compare MAP results by rural-urban status.
Measured: Up to 1 year
Health Behaviors Assessed by Items on Physical Activity
Participant's ability to participate in physical activities (types of activities, intensity, etc.) will be assessed. Descriptive statistics will be used to summarize proximal outcomes. The primary interest will be in estimating the variance for use in planning future studies.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Health Behaviors Assessed by Items on Use of Complementary Health Approaches
Participants will assess the use of complementary or alternative therapies use since first diagnosed with cancer. Descriptive statistics will be used to summarize proximal outcomes. The primary interest will be in estimating the variance for use in planning future studies.
Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Qualitative Assessment of Acceptability With Semi-structured Interviews
Will conduct a qualitative content analysis. Qualitative data will be sent to an external vendor to be transcribed. Two internal study team members will double-code at least 10% of coding of transcripts from the semi-structured interviews and resolve any disagreements to ensure that robust and unbiased results are achieved. Will evaluate qualitative and quantitative analyses in a mixed-methods framework for consistency and discrepancies across all analyses to refine the protocol.
Measured: Up to 1 year
Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews
Will conduct a qualitative content analysis. Qualitative data will be sent to an external vendor to be transcribed. Two internal study team members will double-code at least 10% of coding of transcripts from the semi-structured interviews and resolve any disagreements to ensure that robust and unbiased results are achieved. Will evaluate qualitative and quantitative analyses in a mixed-methods framework for consistency and discrepancies across all analyses to refine the protocol.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start29 May 2018
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- Stephanie Sohl, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520283
- Sponsor's protocol ID
- IRB00048866
- Other IDs
- NCI-2018-00587, CCCWFU 99118, P30CA012197
- Status last verified
- Mar 2021
- First submitted
- 12 Apr 2018
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sohl SJ, Befus D, Tooze JA, Levine B, Golden SL, Puccinelli-Ortega N, Pasche BC, Weaver KE, Lich KH. Feasibility of Systems Support Mapping to guide patient-driven health self-management in colorectal cancer survivors. Psychol Health. 2023 May;38(5):602-622. doi: 10.1080/08870446.2021.1979549. Epub 2021 Sep 27.
PubMed 34570677
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors
- ClinicalTrials.gov ID
- NCT03520283
- Acronym / sponsor ID
- IRB00048866
- Conditions
- Cancer Survivor, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial studies how well systems support mapping works in guiding self-management in stage I-III colorectal cancer survivors. Systems support mapping helps participants to see complex self-management activities on paper, which makes them more actionable. Behavioral interventions, such as systems support mapping, may help colorectal cancer survivors facilitate self-awareness, create motivation for behavior change, and guide self-management.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of the systems support mapping (MAP) intervention in colorectal cancer survivors, as characterized by enrollment, intervention adherence, and retention rates.
SECONDARY OBJECTIVES:
- To evaluate intervention acceptability as characterized by participant ratings.
II. To describe outcome variability to inform future studies. III. To identify multi-level contextual factors influencing self-management (SM).
IV. To qualitatively assess feasibility, acceptability using semi-structured interviews.
- To examine how study results vary by rural-urban context.
OUTLINE:
Participants complete MAP in-clinic over 60-90 minutes.
After completion of study, participants are followed-up for up to 2 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (MAP) | Experimental | Other: Interview, Other: Questionnaire Administration, Behavioral: System Support MappingParticipants complete MAP in-clinic over 60-90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with stage I-III colorectal cancer
- Within 2 years of completing active treatment for colorectal cancer
- Cognitively able to complete interviews as judged by the study team
- Able to understand, read and write English
Key exclusion criteria (1 listed)
- Declined participation 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAncillary studies | Other | Supportive Care (MAP) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (MAP) |
| System Support MappingAlso: MAP Intervention; System Support Mapping Intervention; MAPComplete MAP | Behavioural | Supportive Care (MAP) |
Primary outcome
Enrollment Rate
Time frame: Up to 1 year
To be calculated as the percent of eligible participants approached who agree to participate. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
Participation Rate
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
To be calculated as the percent of participants who complete the study intervention among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
Retention Rate
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
To be calculated as the proportion of participants who complete the study measures among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
14 secondary outcomes
Self-reported Ratings of Intervention Acceptability
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Measures of Autonomy Assessed by Index of Autonomous Functioning
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Self-efficacy for Managing Cancer - Chronic Disease Scale
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Psychological Stress Assessed by Perceived Stress Scale
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Health Behaviors Assessed by Items on Tobacco Use
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Qualitative Assessment of Feasibility With Semi-structured Interviews
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Qualitative Analysis of Systems Support Maps
Time frame: Up to 1 year
Health Behaviors Assessed by Items on Physical Activity
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Health Behaviors Assessed by Items on Use of Complementary Health Approaches
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Qualitative Assessment of Acceptability With Semi-structured Interviews
Time frame: Up to 1 year
Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34570677Sohl SJ, Befus D, Tooze JA, Levine B, Golden SL, Puccinelli-Ortega N, Pasche BC, Weaver KE, Lich KH. Feasibility of Systems Support Mapping to guide patient-driven health self-management in colorectal cancer survivors. Psychol Health. 2023 May;38(5):602-622. doi: 10.1080/08870446.2021.1979549. Epub 2021 Sep 27.
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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.
Stephanie Sohl 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?
A study testing Interview, Questionnaire Administration and System Support Mapping in people with Cancer Survivor and Stage I Colorectal Cancer AJCC v8, 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 4 inclusion and 1 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 19 Apr 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?
Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enrollment Rate (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520283, which also lists 1 linked publication.
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 19 Apr 2021.