Trial Outcomes & Findings for Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors (NCT NCT03520283)

NCT ID: NCT03520283

Last Updated: 2021-04-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2021-04-19

Participant Flow

A total of 66 people were approached to participate in this study. Only 24 were enrolled, 42 declined participation.

Participant milestones

Participant milestones
Measure	Enrolled Participants Baseline characteristics of study participants that actually participated in study interventions.	Declined Participants Baseline characteristics of potential participants that declined participation
Overall Study STARTED	24	42
Overall Study COMPLETED	24	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Information was not collected for DECLINED PARTICIPANTS

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 1 year

Population: Out of 66 participants asked to participate, only 24 were eligible/enrolled into the intervention.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=66 Participants 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.
Enrollment Rate	0.36 Percent probability of participants Interval 0.25 to 0.49

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Participation Rate	0.88 percentage of completed intervention Interval 0.68 to 0.97

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Retention Rate	0.83 proportion of completed study measures Interval 0.63 to 0.95

SECONDARY outcome

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

Population: 20 out of 24 participants were assessed at follow-up.

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

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=20 Participants 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.
Self-reported Ratings of Intervention Acceptability Liked the intervention quite a bit/very much	16 Participants
Self-reported Ratings of Intervention Acceptability Liked the intervention a little bit/somewhat	4 Participants
Self-reported Ratings of Intervention Acceptability Found intervention helpful very much/quite a bit	15 Participants
Self-reported Ratings of Intervention Acceptability Found intervention helpful a little bit/somewhat	5 Participants
Self-reported Ratings of Intervention Acceptability Would continue to use what they learned quite a bit/very much	18 Participants
Self-reported Ratings of Intervention Acceptability Would continue to use what they learned a little bit/somewhat	2 Participants
Self-reported Ratings of Intervention Acceptability Found interventionist competent and sensitive quite a bit/very much	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Measures of Autonomy Assessed by Index of Autonomous Functioning Baseline	4.4 score on a scale Standard Deviation 0.6
Measures of Autonomy Assessed by Index of Autonomous Functioning Two weeks	4.7 score on a scale Standard Deviation 0.4
Measures of Autonomy Assessed by Index of Autonomous Functioning Difference in time points	0.4 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Self-efficacy for Managing Cancer - Chronic Disease Scale Baseline	7.7 score on a scale Standard Deviation 2.1
Self-efficacy for Managing Cancer - Chronic Disease Scale Two weeeks	8.6 score on a scale Standard Deviation 1.5
Self-efficacy for Managing Cancer - Chronic Disease Scale Difference between the two time points	0.6 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form Baseline	49.8 score on a scale Standard Deviation 8.4
Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form Two weeeks	55.2 score on a scale Standard Deviation 8.6
Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form Difference between the two time points	4.3 score on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection	66.2 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Psychological Stress Assessed by Perceived Stress Scale Baseline	8.1 score on a scale Standard Deviation 1.9
Psychological Stress Assessed by Perceived Stress Scale Two weeks	6.7 score on a scale Standard Deviation 2.9
Psychological Stress Assessed by Perceived Stress Scale Difference in both time points	-1.0 score on a scale Standard Deviation 2.2

SECONDARY outcome

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

Population: Not all eligible participants may have completed the intervention. The difference scores are computed only on the n=20 (or 18) who have \*both\* scores, which is why the difference scores are different from simply taking the difference of the 2 reported means

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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Physical Function - Baseline	46.0 T-score on a scale Standard Deviation 8.5
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Physical Function at Follow-Up	47.3 T-score on a scale Standard Deviation 10.4
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Physical Function - Difference between the two time points	0.2 T-score on a scale Standard Deviation 6.5
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Anxiety - Baseline	50.3 T-score on a scale Standard Deviation 8.8
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Anxiety at Follow-Up	46.4 T-score on a scale Standard Deviation 8.5
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Anxiety - Difference between the two time points	-2.3 T-score on a scale Standard Deviation 6.7
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Depression - Baseline	47.1 T-score on a scale Standard Deviation 7.7
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Depression at Follow-Up	45.3 T-score on a scale Standard Deviation 6.1
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Depression - Difference between the two time points	-0.1 T-score on a scale Standard Deviation 5.7
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Fatigue - Baseline	51.9 T-score on a scale Standard Deviation 10.15
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Fatigue at Follow-Up	46.2 T-score on a scale Standard Deviation 9.4
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Fatigue - Difference between the two time points	-4.7 T-score on a scale Standard Deviation 6.9
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Sleep Disturbance - Baseline	52.1 T-score on a scale Standard Deviation 7.8
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Sleep Disturbance at Follow-Up	49.3 T-score on a scale Standard Deviation 9.3
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Sleep Disturbance - Difference between the two time points	-1.8 T-score on a scale Standard Deviation 6.3
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Social Roles - Baseline	50.1 T-score on a scale Standard Deviation 8.3
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Social Roles at Follow-Up	52.0 T-score on a scale Standard Deviation 10.6
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Social Roles - Difference between the two time points	1.6 T-score on a scale Standard Deviation 8.9
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Pain Interference - Baseline	52.4 T-score on a scale Standard Deviation 9.5
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Pain Interference at Follow-Up	51.4 T-score on a scale Standard Deviation 10.0
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Pain Interference - Difference between the two time points	-0.9 T-score on a scale Standard Deviation 7.2
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Pain Intensity - Baseline	3.0 T-score on a scale Standard Deviation 2.8
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Pain Intensity at Follow-Up	2.5 T-score on a scale Standard Deviation 2.6
Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 Pain Intensity - Difference between the two time points	-0.6 T-score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Health Behaviors Assessed by Items on Tobacco Use Ever-smokers	6 Participants
Health Behaviors Assessed by Items on Tobacco Use Never smokers	18 Participants
Health Behaviors Assessed by Items on Tobacco Use Last cigarette more than 1 year ago prior to baseline survey	6 Participants

SECONDARY outcome

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

Population: Qualitative interview data was collected from 19 participants. Information gained related to study processes enhanced understanding of quantitative results and will inform the next phase of study

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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Qualitative Assessment of Feasibility With Semi-structured Interviews	19 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: Textual data from the intervention mapping was collected from 21 participants. Content analysis identified multi-level contextual factors influencing self-management and results were examined by rural-urban status.

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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Qualitative Analysis of Systems Support Maps	21 Participants

SECONDARY outcome

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

Population: Not all participants may have completed the intervention

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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Health Behaviors Assessed by Items on Physical Activity Rarely or never do any physical activity - Baseline	3 Participants
Health Behaviors Assessed by Items on Physical Activity Rarely or never do any physical activity - At two weeks	3 Participants
Health Behaviors Assessed by Items on Physical Activity Do some light/moderate physical activity but not every week - Baseline	7 Participants
Health Behaviors Assessed by Items on Physical Activity Do some light/moderate physical activity but not every week - At two weeks	4 Participants
Health Behaviors Assessed by Items on Physical Activity Light physical activity every week - Baseline	16 Participants
Health Behaviors Assessed by Items on Physical Activity Light physical activity every week - At two weeks	15 Participants
Health Behaviors Assessed by Items on Physical Activity Moderate physical activity every week but less than 30 minutes a day or 5 days a week - Baseline	11 Participants
Health Behaviors Assessed by Items on Physical Activity Moderate physical activity every week but less than 30 minutes a day or 5 days a week - At two weeks	10 Participants
Health Behaviors Assessed by Items on Physical Activity Vigorous activity every week but less than 20 minutes a day or three days a week - Baseline	4 Participants
Health Behaviors Assessed by Items on Physical Activity Vigorous activity every week but less than 20 minutes a day or three days a week - At two weeks	2 Participants
Health Behaviors Assessed by Items on Physical Activity 30 minutes or more of moderate activity five or more days a week - Baseline	6 Participants
Health Behaviors Assessed by Items on Physical Activity 30 minutes or more of moderate activity five or more days a week - At two weeks	8 Participants
Health Behaviors Assessed by Items on Physical Activity 20 min or more of vigorous activity 3 or more days a week - Baseline	4 Participants
Health Behaviors Assessed by Items on Physical Activity 20 min or more of vigorous activity 3 or more days a week - At two weeks	2 Participants

SECONDARY outcome

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

Population: Not all participants completed interventions in the two week (follow up) time frame

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.

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Personal prayer in past year	14 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Special Diets in the past year	3 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Special Diets in the past two weeks	3 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Natural Products in the past year	4 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Natural products in the past two weeks	4 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Mind/body therapies in the past year	8 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Mind/body therapies in the past two weeks	5 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Personal prayer in the past two weeks	12 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Other stress support in the past year	1 Participants
Health Behaviors Assessed by Items on Use of Complementary Health Approaches Other stress support in the past two weeks	2 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Qualitative Assessment of Acceptability With Semi-structured Interviews	19 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Enrollment Rate - Eligible Participants n=24 Participants 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.
Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews	19 Participants

Adverse Events

Supportive Care (MAP)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Supportive Care (MAP) n=24 participants at risk Participants complete MAP in-clinic over 60-90 minutes. Interview: Ancillary studies Questionnaire Administration: Ancillary studies System Support Mapping: Complete MAP
Psychiatric disorders Tearfulness	8.3% 2/24 • Number of events 2 • Two weeks following the intervention

Additional Information

Study coordinator

Wake Forest University Health Sciences

Phone: 336-716-9055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Enrolled Participants n=24 Participants Baseline characteristics of study participants that actually participated in study interventions.	Declined Participants n=42 Participants Baseline characteristics of potential participants that declined participation	Total n=66 Participants Total of all reporting groups
Age, Continuous	60.91 Years STANDARD_DEVIATION 15.70 • n=24 Participants	66.9 Years STANDARD_DEVIATION 11.29 • n=42 Participants	63.90 Years STANDARD_DEVIATION 13.49 • n=66 Participants
Sex: Female, Male Female	15 Participants n=24 Participants	22 Participants n=42 Participants	37 Participants n=66 Participants
Sex: Female, Male Male	9 Participants n=24 Participants	20 Participants n=42 Participants	29 Participants n=66 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=66 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=24 Participants	42 Participants n=42 Participants	64 Participants n=66 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=66 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Black or African American	2 Participants n=24 Participants	5 Participants n=42 Participants	7 Participants n=66 Participants
Race (NIH/OMB) White	20 Participants n=24 Participants	37 Participants n=42 Participants	57 Participants n=66 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=66 Participants
Region of Enrollment United States	24 participants n=24 Participants	42 participants n=42 Participants	66 participants n=66 Participants
Marital Status Married or Living with Partner	13 Participants n=23 Participants • Information was not collected for DECLINED PARTICIPANTS	—	13 Participants n=23 Participants • Information was not collected for DECLINED PARTICIPANTS
Marital Status Separated/Divorced	2 Participants n=23 Participants • Information was not collected for DECLINED PARTICIPANTS	—	2 Participants n=23 Participants • Information was not collected for DECLINED PARTICIPANTS
Marital Status Widowed/Single	8 Participants n=23 Participants • Information was not collected for DECLINED PARTICIPANTS	—	8 Participants n=23 Participants • Information was not collected for DECLINED PARTICIPANTS
Education Level Less than high school/High school graduate	3 Participants n=23 Participants • Data only reported for participants who answered questions	—	3 Participants n=23 Participants • Data only reported for participants who answered questions
Education Level Technical school/Some college	9 Participants n=23 Participants • Data only reported for participants who answered questions	—	9 Participants n=23 Participants • Data only reported for participants who answered questions
Education Level College graduate/Post graduate degree	11 Participants n=23 Participants • Data only reported for participants who answered questions	—	11 Participants n=23 Participants • Data only reported for participants who answered questions
Difficulty Paying Monthly Bills Very/somewhat difficult	6 Participants n=22 Participants • Data only reported for participants who answered questions	—	6 Participants n=22 Participants • Data only reported for participants who answered questions
Difficulty Paying Monthly Bills Not very difficult	11 Participants n=22 Participants • Data only reported for participants who answered questions	—	11 Participants n=22 Participants • Data only reported for participants who answered questions
Difficulty Paying Monthly Bills Not at all diffcult	5 Participants n=22 Participants • Data only reported for participants who answered questions	—	5 Participants n=22 Participants • Data only reported for participants who answered questions
Confident in Filling Out Medical Forms (Health Literacy) Extremely/Quite a Bit	20 Participants n=23 Participants • Data only reported for participants who answered questions	—	20 Participants n=23 Participants • Data only reported for participants who answered questions
Confident in Filling Out Medical Forms (Health Literacy) Somewhat/A Little Bit/Not at all	3 Participants n=23 Participants • Data only reported for participants who answered questions	—	3 Participants n=23 Participants • Data only reported for participants who answered questions
Times Received Income from AFDC, TANF, Work First, WIC or food stamps Never	19 Participants n=23 Participants • Data only reported for participants who answered questions	—	19 Participants n=23 Participants • Data only reported for participants who answered questions
Times Received Income from AFDC, TANF, Work First, WIC or food stamps Four times or less	3 Participants n=23 Participants • Data only reported for participants who answered questions	—	3 Participants n=23 Participants • Data only reported for participants who answered questions
Times Received Income from AFDC, TANF, Work First, WIC or food stamps More than four times	1 Participants n=23 Participants • Data only reported for participants who answered questions	—	1 Participants n=23 Participants • Data only reported for participants who answered questions
Rural Residence as Defined by Federal Office of Rural Health Policy (FORHP) Rural Residence as defined by FORHP	5 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS. The FORHP accepts all non-Metro counties as rural and uses an additional method of determining rurality called the Rural-Urban Commuting Area (RUCA) codes. Like the MSAs, these are based on Census data that is used to assign a code to each Census Tract. Tracts inside Metropolitan counties with the codes 4-10 are considered rural.	—	5 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS. The FORHP accepts all non-Metro counties as rural and uses an additional method of determining rurality called the Rural-Urban Commuting Area (RUCA) codes. Like the MSAs, these are based on Census data that is used to assign a code to each Census Tract. Tracts inside Metropolitan counties with the codes 4-10 are considered rural.
Rural Residence as Defined by Federal Office of Rural Health Policy (FORHP) Not living in a rural residence	19 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS. The FORHP accepts all non-Metro counties as rural and uses an additional method of determining rurality called the Rural-Urban Commuting Area (RUCA) codes. Like the MSAs, these are based on Census data that is used to assign a code to each Census Tract. Tracts inside Metropolitan counties with the codes 4-10 are considered rural.	—	19 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS. The FORHP accepts all non-Metro counties as rural and uses an additional method of determining rurality called the Rural-Urban Commuting Area (RUCA) codes. Like the MSAs, these are based on Census data that is used to assign a code to each Census Tract. Tracts inside Metropolitan counties with the codes 4-10 are considered rural.
Use of Internet or Email Yes	22 Participants n=24 Participants • Information was no collected for DECLINED PARTICIPANTS.	—	22 Participants n=24 Participants • Information was no collected for DECLINED PARTICIPANTS.
Use of Internet or Email No	2 Participants n=24 Participants • Information was no collected for DECLINED PARTICIPANTS.	—	2 Participants n=24 Participants • Information was no collected for DECLINED PARTICIPANTS.
Cancer Type Colon cancer	17 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	17 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Cancer Type Rectal cancer	7 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	7 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Summary Disease Stage at Diagnosis Stage I	5 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	5 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Summary Disease Stage at Diagnosis Stage II	7 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	7 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Summary Disease Stage at Diagnosis Stage III	12 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	12 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Recurrent Disease Yes	0 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	0 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Recurrent Disease No	24 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	24 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Underwent Surgery Yes	23 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	23 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Underwent Surgery No	1 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	1 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Received Radiation Yes	9 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	9 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Received Radiation No	15 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	15 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Received Chemotherapy Yes	17 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	17 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Received Chemotherapy No	7 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	7 Participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Number of Comorbidities (Range 0-14)	1 median of comorbidities of participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	1 median of comorbidities of participants n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Months Since Last Cancer Treatment	9 months n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	9 months n=24 Participants • Information was not collected for DECLINED PARTICIPANTS
Minutes Traveled to Clinic	34 minutes n=24 Participants • Information was not collected for DECLINED PARTICIPANTS	—	34 minutes n=24 Participants • Information was not collected for DECLINED PARTICIPANTS