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Cancer SurvivorNCT03520283

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

A study testing Interview, Questionnaire Administration and System Support Mapping in people with Cancer Survivor and Stage I Colorectal Cancer AJCC v8, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interview, Questionnaire Administration and System Support Mapping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
29 May 2018to 6 Feb 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Declined participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
Interview, Questionnaire Administration, System Support Mapping
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterviewOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • System Support MappingBehavioural

    Also called MAP Intervention; System Support Mapping Intervention; MAP

    Complete MAP

Study groups in NCT03520283
Study groupRoleWhat they receive
Supportive Care (MAP)ExperimentalParticipants complete MAP in-clinic over 60-90 minutes.
Receives: Other: Interview; Other: Questionnaire Administration; Behavioral: System Support Mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 1 year

  2. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  3. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

Secondary outcomes (14)
  1. Self-reported Ratings of Intervention Acceptability

    Descriptive statistics will be used to summarize participant ratings of acceptability of intervention.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  2. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  3. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  4. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  5. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  6. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  7. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  8. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  9. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  10. 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.

    Measured: Up to 1 year

  11. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  12. 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.

    Measured: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later

  13. 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.

    Measured: Up to 1 year

  14. 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.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2018
  2. Study start29 May 2018
  3. Primary completion6 Feb 2020
  4. Study completion6 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03520283
Sponsor's protocol ID
IRB00048866
Other IDs
NCI-2018-00587, CCCWFU 99118, P30CA012197
Status last verified
Mar 2021
First submitted
12 Apr 2018
Last updated
19 Apr 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34570677

Questions about this trial

What is this clinical trial studying?

A study testing Interview, Questionnaire Administration and System Support Mapping in people with Cancer Survivor and Stage I Colorectal Cancer AJCC v8, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Rate (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03520283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.

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