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

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ClinicalTrials.gov Identifier: NCT03520283
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
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 Other: Interview Other: Questionnaire Administration Behavioral: System Support Mapping Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (MAP)
Participants complete MAP in-clinic over 60-90 minutes.
Other: Interview
Ancillary studies

Other: Questionnaire Administration
Ancillary studies

Behavioral: System Support Mapping
Complete MAP
Other Name: MAP Intervention; System Support Mapping Intervention; MAP




Primary Outcome Measures :
  1. 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.

  2. Participation rate [ Time Frame: Up to 1 year ]
    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.

  3. Retention rate [ Time Frame: Up to 1 year ]
    To be calculated as the number 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 :
  1. Self-reported ratings of intervention acceptability [ Time Frame: Up to 1 year ]
    Descriptive statistics will be used to summarize participant ratings of acceptability.

  2. Measures of autonomy assessed by Index of Autonomous Functioning [ Time Frame: Up to 1 year ]
    Descriptive statistics (means, standard deviations, 95% confidence intervals) 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.

  3. Self-efficacy for managing cancer assessed by Self-efficacy to Manage Chronic Disease Scale and Patient Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing symptoms short form [ Time Frame: Up to 1 year ]
    Descriptive statistics (means, standard deviations, 95% confidence intervals) 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.

  4. Relatedness assessed by HEAL Patient-Provider Connection [ Time Frame: Up to 1 year ]
    Descriptive statistics (means, standard deviations, 95% confidence intervals) 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.

  5. Psychological stress assessed by Perceived Stress Scale [ Time Frame: Up to 1 year ]
    The internal study team will work with external collaborators through an iterative process to facilitate a qualitative content analysis of the large quantity of textual systems support mapping (MAP) data.

  6. Symptoms assessed by PROMIS Profile 29 [ Time Frame: Up to 1 year ]
    The internal study team will work with external collaborators through an iterative process to facilitate a qualitative content analysis of the large quantity of textual MAP data.

  7. Health behaviors assessed by items on tobacco use [ Time Frame: Up to 1 year ]
    The internal study team will work with external collaborators through an iterative process to facilitate a qualitative content analysis of the large quantity of textual MAP data.

  8. Qualitative assessment of feasibility with semi-structured interviews [ Time Frame: Up to 1 year ]
    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.

  9. Qualitative analysis of systems support maps [ Time Frame: Up to 1 year ]
    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.

  10. Health behaviors assessed by items on physical activity [ Time Frame: Up to 1 year ]
    The internal study team will work with external collaborators through an iterative process to facilitate a qualitative content analysis of the large quantity of textual MAP data.

  11. Health behaviors assessed by items on use of complementary health approaches [ Time Frame: Up to 1 year ]
    The internal study team will work with external collaborators through an iterative process to facilitate a qualitative content analysis of the large quantity of textual MAP data.

  12. Qualitative assessment of acceptability with semi-structured interviews [ Time Frame: Up to 1 year ]
    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.

  13. Qualitative assessment of changes in outcomes with semi-structured interviews [ Time Frame: Up to 1 year ]
    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.

  14. Quantitative analysis of systems support maps [ Time Frame: Up to 1 year ]
    Will examine all quantitative analyses by urban-rural status as classified using Rural Urban Commuting Area Codes. For quantitative measures, will compute descriptive statistics by urban-rural status and will use Fisher's exact tests and Wilcoxon rank sum tests to compare urban and rural participants.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with stage I-III colorectal cancer
  • Within 12 months 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520283


Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stephanie J. Sohl    336-713-5093    ssohl@wakehealth.edu   
Principal Investigator: Stephanie J. Sohl         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephanie Sohl Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03520283     History of Changes
Other Study ID Numbers: IRB00048866
NCI-2018-00587 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 99118 ( Other Identifier: Wake Forest University Health Sciences )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases