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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520283
Recruitment Status : Completed
First Posted : May 9, 2018
Results First Posted : April 19, 2021
Last Update Posted : April 19, 2021
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
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
Actual Primary Completion Date : February 6, 2020
Actual Study Completion Date : February 6, 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: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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 :
  1. Self-reported Ratings of Intervention Acceptability [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    Descriptive statistics will be used to summarize participant ratings of acceptability of intervention.

  2. Measures of Autonomy Assessed by Index of Autonomous Functioning [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  3. Self-efficacy for Managing Cancer - Chronic Disease Scale [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  4. Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  5. PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  6. Psychological Stress Assessed by Perceived Stress Scale [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  7. Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  8. Health Behaviors Assessed by Items on Tobacco Use [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  9. Qualitative Assessment of Feasibility With Semi-structured Interviews [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  10. Qualitative Analysis of Systems Support Maps [ Time Frame: Up to 1 year ]
    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.

  11. Health Behaviors Assessed by Items on Physical Activity [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  12. Health Behaviors Assessed by Items on Use of Complementary Health Approaches [ Time Frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later ]
    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.

  13. 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.

  14. 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.



Information from the National Library of Medicine

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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 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

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
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stephanie Sohl Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Informed Consent Form  [PDF] March 11, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03520283    
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
Results First Posted: April 19, 2021
Last Update Posted: April 19, 2021
Last Verified: March 2021

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases