Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors

Cancer Survivor Clinical Trial

Official title:

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520283
• Other study ID #: IRB00048866
• Secondary ID: NCI-2018-00587CC
• Status: Completed
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: February 6, 2020

Study information

• Verified date: March 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Behavioral interventions, such as systems support mapping, may help colorectal cancer survivors facilitate self-awareness, create motivation for behavior change, and guide self-management.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Colorectal Neoplasms
• 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

Intervention

Other:
• Interview
Ancillary studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• System Support Mapping
Complete MAP

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Self-reported Ratings of Intervention Acceptability	Descriptive statistics will be used to summarize participant ratings of acceptability of intervention.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Up to 1 year
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary	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.	Up to 1 year
Secondary	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.	Up to 1 year