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Completed

NCT Number: NCT03520283

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

System Support Mapping

Behavioral

Complete MAP

Other names: MAP Intervention; System Support Mapping Intervention; MAP

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 9, 2018
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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