Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors
Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors
4 other identifiers
interventional
24
1 country
1
Brief 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. Behavioral interventions, such as systems support mapping, may help colorectal cancer survivors facilitate self-awareness, create motivation for behavior change, and guide self-management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedStudy Start
First participant enrolled
May 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2020
CompletedResults Posted
Study results publicly available
April 19, 2021
CompletedApril 19, 2021
March 1, 2021
1.7 years
April 12, 2018
February 22, 2021
March 19, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
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
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
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
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
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
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
- +9 more secondary outcomes
Study Arms (1)
Supportive Care (MAP)
EXPERIMENTALParticipants complete MAP in-clinic over 60-90 minutes.
Interventions
Complete MAP
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Declined participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
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.
PMID: 34570677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study coordinator
- Organization
- Wake Forest University Health Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Sohl
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2018
First Posted
May 9, 2018
Study Start
May 29, 2018
Primary Completion
February 6, 2020
Study Completion
February 6, 2020
Last Updated
April 19, 2021
Results First Posted
April 19, 2021
Record last verified: 2021-03