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

Primary Purpose

Cancer Survivor, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interview
Questionnaire Administration
System Support Mapping
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (MAP)

Arm Description

Participants complete MAP in-clinic over 60-90 minutes.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Self-reported Ratings of Intervention Acceptability
Descriptive statistics will be used to summarize participant ratings of acceptability of intervention.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 12, 2018
Last Updated
March 19, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03520283
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
February 6, 2020 (Actual)
Study Completion Date
February 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (MAP)
Arm Type
Experimental
Arm Description
Participants complete MAP in-clinic over 60-90 minutes.
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
System Support Mapping
Other Intervention Name(s)
MAP Intervention; System Support Mapping Intervention; MAP
Intervention Description
Complete MAP
Primary Outcome Measure Information:
Title
Enrollment Rate
Description
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.
Time Frame
Up to 1 year
Title
Participation Rate
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Retention Rate
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Secondary Outcome Measure Information:
Title
Self-reported Ratings of Intervention Acceptability
Description
Descriptive statistics will be used to summarize participant ratings of acceptability of intervention.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Measures of Autonomy Assessed by Index of Autonomous Functioning
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Self-efficacy for Managing Cancer - Chronic Disease Scale
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Psychological Stress Assessed by Perceived Stress Scale
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Health Behaviors Assessed by Items on Tobacco Use
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Qualitative Assessment of Feasibility With Semi-structured Interviews
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Qualitative Analysis of Systems Support Maps
Description
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.
Time Frame
Up to 1 year
Title
Health Behaviors Assessed by Items on Physical Activity
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Health Behaviors Assessed by Items on Use of Complementary Health Approaches
Description
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.
Time Frame
Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
Title
Qualitative Assessment of Acceptability With Semi-structured Interviews
Description
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.
Time Frame
Up to 1 year
Title
Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Sohl
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34570677
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.
Results Reference
derived

Learn more about this trial

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

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