Clinical trial NCT03520283: Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors
Official title: Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Stage III Colorectal Cancer AJCC v8
Stage IIIA Colorectal Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Stage IIIC Colorectal Cancer AJCC v8
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

I. 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.

V. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Declined participation in the study

Primary outcomes:
measure: Enrollment Rate
timeFrame: Up to 1 year
measure: Participation Rate
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Retention Rate
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary outcomes:
measure: Self-reported Ratings of Intervention Acceptability
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Measures of Autonomy Assessed by Index of Autonomous Functioning
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Self-efficacy for Managing Cancer - Chronic Disease Scale
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Psychological Stress Assessed by Perceived Stress Scale
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Health Behaviors Assessed by Items on Tobacco Use
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Qualitative Assessment of Feasibility With Semi-structured Interviews
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Qualitative Analysis of Systems Support Maps
timeFrame: Up to 1 year
measure: Health Behaviors Assessed by Items on Physical Activity
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Health Behaviors Assessed by Items on Use of Complementary Health Approaches
timeFrame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
measure: Qualitative Assessment of Acceptability With Semi-structured Interviews
timeFrame: Up to 1 year
measure: Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephanie Sohl
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.