NCT03520283

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

Completed NA Results posted Last updated 19 April 2021

What this trial tests

NA trial testing Interview in Cancer Survivor in 24 participants. Completed in 6 February 2020.

Timeline

29 May 2018

Primary endpoint
6 February 2020

6 February 2020

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	24
Start date	29 May 2018
Primary completion	6 February 2020
Estimated completion	6 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Interview
• Questionnaire Administration
• System Support Mapping

Conditions studied

• Cancer Survivor — all drugs for Cancer Survivor →
• Stage I Colorectal Cancer AJCC v8 — all drugs for Stage I Colorectal Cancer AJCC v8 →
• Stage II Colorectal Cancer AJCC v8 — all drugs for Stage II Colorectal Cancer AJCC v8 →
• Stage IIA Colorectal Cancer AJCC v8 — all drugs for Stage IIA Colorectal Cancer AJCC v8 →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Cancer Survivor or Stage I Colorectal Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Enrollment Rate Primary · 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.

Group	Value	95% CI
Enrollment Rate - Eligible Participants	0.36	0.25 – 0.49

Participation Rate Primary · 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.

Group	Value	95% CI
Participation Rate - Eligible Participants	0.88	0.68 – 0.97

Retention Rate Primary · 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.

Group	Value	95% CI
Retention Rate - Eligible Participants	0.83	0.63 – 0.95

Self-reported Ratings of Intervention Acceptability Secondary · 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.

Liked the intervention quite a bit/very much

Group	Value	95% CI
Self-reported Ratings of Intervention Acceptability - Eligible Participants	16

Liked the intervention a little bit/somewhat

Group	Value	95% CI
Self-reported Ratings of Intervention Acceptability - Eligible Participants	4

Found intervention helpful very much/quite a bit

Group	Value	95% CI
Self-reported Ratings of Intervention Acceptability - Eligible Participants	15

Found intervention helpful a little bit/somewhat

Group	Value	95% CI
Self-reported Ratings of Intervention Acceptability - Eligible Participants	5

Would continue to use what they learned quite a bit/very much

Group	Value	95% CI
Self-reported Ratings of Intervention Acceptability - Eligible Participants	18

Would continue to use what they learned a little bit/somewhat

Group	Value	95% CI
Self-reported Ratings of Intervention Acceptability - Eligible Participants	2

Found interventionist competent and sensitive quite a bit/very much

Group	Value	95% CI
Self-reported Ratings of Intervention Acceptability - Eligible Participants	20

Measures of Autonomy Assessed by Index of Autonomous Functioning Secondary · 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.

Baseline

Group	Value	95% CI
Measures of Autonomy Assessed by Index of Autonomous Functioning	4.4	± 0.6

Two weeks

Group	Value	95% CI
Measures of Autonomy Assessed by Index of Autonomous Functioning	4.7	± 0.4

Difference in time points

Group	Value	95% CI
Measures of Autonomy Assessed by Index of Autonomous Functioning	0.4	± 0.6

Self-efficacy for Managing Cancer - Chronic Disease Scale Secondary · 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.

Baseline

Group	Value	95% CI
Self-efficacy for Managing Cancer - Chronic Disease Scale	7.7	± 2.1

Two weeeks

Group	Value	95% CI
Self-efficacy for Managing Cancer - Chronic Disease Scale	8.6	± 1.5

Difference between the two time points

Group	Value	95% CI
Self-efficacy for Managing Cancer - Chronic Disease Scale	0.6	± 1.2

Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form Secondary · 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.

Baseline

Group	Value	95% CI
Self-Efficacy for Managing Symptoms - (PROMIS) Short Form	49.8	± 8.4

Two weeeks

Group	Value	95% CI
Self-Efficacy for Managing Symptoms - (PROMIS) Short Form	55.2	± 8.6

Difference between the two time points

Group	Value	95% CI
Self-Efficacy for Managing Symptoms - (PROMIS) Short Form	4.3	± 7.4

PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection Secondary · 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.

Group	Value	95% CI
PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists Patient-Provider Connection	66.2	± 7.5

Psychological Stress Assessed by Perceived Stress Scale Secondary · 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.

Baseline

Group	Value	95% CI
Psychological Stress Assessed by Perceived Stress Scale - Eligible Participants	8.1	± 1.9

Two weeks

Group	Value	95% CI
Psychological Stress Assessed by Perceived Stress Scale - Eligible Participants	6.7	± 2.9

Difference in both time points

Group	Value	95% CI
Psychological Stress Assessed by Perceived Stress Scale - Eligible Participants	-1.0	± 2.2

Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Secondary · 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 refer

Physical Function - Baseline

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	46.0	± 8.5

Physical Function at Follow-Up

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	47.3	± 10.4

Physical Function - Difference between the two time points

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	0.2	± 6.5

Anxiety - Baseline

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	50.3	± 8.8

Anxiety at Follow-Up

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	46.4	± 8.5

Anxiety - Difference between the two time points

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	-2.3	± 6.7

Depression - Baseline

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	47.1	± 7.7

Depression at Follow-Up

Group	Value	95% CI
Symptoms Assessed by PROMIS Profile 29 - Eligible Participants	45.3	± 6.1

Health Behaviors Assessed by Items on Tobacco Use Secondary · 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.

Ever-smokers

Group	Value	95% CI
Health Behaviors - Tobacco Use	6

Never smokers

Group	Value	95% CI
Health Behaviors - Tobacco Use	18

Last cigarette more than 1 year ago prior to baseline survey

Group	Value	95% CI
Health Behaviors - Tobacco Use	6

Qualitative Assessment of Feasibility With Semi-structured Interviews Secondary · 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.

Group	Value	95% CI
Enrolled Participants	19

Adverse events — posted to ClinicalTrials.gov

Time frame: Two weeks following the intervention. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Supportive Care (MAP)

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (1 terms — click to expand)

Reaction	System	Supportive Care (MAP)
Tearfulness	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT03520283 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of Systems Support Mapping to guide patient-driven health self-management in colorectal cancer survivors.
   Sohl SJ, Befus D, Tooze JA, Levine B, et al · · 2023 · cited 8× · PMID 34570677 · DOI 10.1080/08870446.2021.1979549