Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants complete MAP in-clinic over 60-90 minutes.

Interview

Questionnaire Administration

System Support Mapping

Stephanie Sohl

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.

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.

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

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Participants complete MAP in-clinic over 60-90 minutes.

Interview: Ancillary studies

Questionnaire Administration: Ancillary studies

System Support Mapping: Complete MAP

Supportive Care (MAP)

Baseline characteristics of study participants that actually participated in study interventions.

Enrolled Participants

Baseline characteristics of potential participants that declined participation

Declined Participants

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Married or Living with Partner

Separated/Divorced

Widowed/Single

Data only reported for participants who answered questions

Information was not collected for DECLINED PARTICIPANTS

Marital Status

Less than high school/High school graduate

Technical school/Some college

College graduate/Post graduate degree

Education Level

Very/somewhat difficult

Not very difficult

Not at all diffcult

Difficulty Paying Monthly Bills

Extremely/Quite a Bit

Somewhat/A Little Bit/Not at all

Confident in Filling Out Medical Forms (Health Literacy)

Never

Four times or less

More than four times

Times Received Income from AFDC, TANF, Work First, WIC or food stamps

Rural Residence as defined by FORHP

Not living in a rural residence

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)

Information was no collected for DECLINED PARTICIPANTS.

Use of Internet or Email

Colon cancer

Rectal cancer

Cancer Type

Stage I

Stage II

Stage III

Part of the eligibility criteria were participants had to have a diagnosis of Stage I-III colorectal cancer based on the American Joint Committee on Cancer (AJCC) Tumor, lymph Nodes and Metastasis (TNM) system. The lower the stage number, the less the cancer has spread.

Summary Disease Stage at Diagnosis

Recurrent Disease

Underwent Surgery

Received Radiation

Received Chemotherapy

Number of Comorbidities (Range 0-14)

Months Since Last Cancer Treatment

Minutes Traveled to Clinic

Study coordinator

Enrollment Rate - Eligible Participants

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

Enrollment Rate

Participation Rate - Eligible Participants

Participation Rate

To be calculated as the number 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.

Retention Rate - Eligible Participants

Retention Rate

Liked the intervention quite a bit/very much

Liked the intervention a little bit/somewhat

Found intervention helpful very much/quite a bit

Found intervention helpful a little bit/somewhat

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

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

Found interventionist competent and sensitive quite a bit/very much

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

Self-reported Ratings of Intervention Acceptability - Eligible Participants

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

Self-reported Ratings of Intervention Acceptability

Baseline

Two weeks

Difference in time points

Autonomy will be assessed at baseline and at 2 weeks with a difference of the two time points.

Measures of Autonomy Assessed by Index of Autonomous Functioning

Two weeeks

Difference between the two time points

Self-efficacy for managing cancer will be assessed as a mean value at baseline and at two weeks with a difference of values between the two time points.

Self-efficacy for Managing Cancer - Chronic Disease Scale

Self-Efficacy for Managing Symptoms - (PROMIS) Short Form

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

Relatedness to interventionists was measured at 2 weeks after intervention.

PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists Patient-Provider Connection

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

Difference in both time points

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.

Psychological Stress Assessed by Perceived Stress Scale - Eligible Participants

Psychological Stress Assessed by Perceived Stress Scale

Physical Function - Baseline

Physical Function at Follow-Up

Physical Function - Difference between the two time points

Anxiety - Baseline

Anxiety at Follow-Up

Anxiety - Difference between the two time points

Depression - Baseline

Depression at Follow-Up

Depression - Difference between the two time points

Fatigue - Baseline

Fatigue at Follow-Up

Fatigue - Difference between the two time points

Sleep Disturbance - Baseline

Sleep Disturbance at Follow-Up

Sleep Disturbance - Difference between the two time points

Social Roles - Baseline

Social Roles at Follow-Up

Social Roles - Difference between the two time points

Pain Interference - Baseline

Pain Interference at Follow-Up

Pain Interference - Difference between the two time points

Pain Intensity - Baseline

Pain Intensity at Follow-Up

Pain Intensity - Difference between the two time points

Symptoms Assessed by PROMIS Profile 29 - Eligible Participants

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

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

Ever-smokers

Never smokers

Last cigarette more than 1 year ago prior to baseline survey

Participants' status of tobacco use will be assessed during at baseline survey.

Health Behaviors - Tobacco Use

Health Behaviors Assessed by Items on Tobacco Use

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

Qualitative Assessment of Feasibility With Semi-structured Interviews

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.

Qualitative Analysis of Systems Support Maps

Rarely or never do any physical activity - Baseline

Rarely or never do any physical activity - At two weeks

Do some light/moderate physical activity but not every week - Baseline

Do some light/moderate physical activity but not every week - At two weeks

Light physical activity every week - Baseline

Light physical activity every week - At two weeks

Moderate physical activity every week but less than 30 minutes a day or 5 days a week - Baseline

Moderate physical activity every week but less than 30 minutes a day or 5 days a week - At two weeks

Vigorous activity every week but less than 20 minutes a day or three days a week - Baseline

Vigorous activity every week but less than 20 minutes a day or three days a week - At two weeks

30 minutes or more of moderate activity five or more days a week - Baseline

30 minutes or more of moderate activity five or more days a week - At two weeks

20 min or more of vigorous activity 3 or more days a week - Baseline

20 min or more of vigorous activity 3 or more days a week - At two weeks

Not all participants may have completed the intervention

Health Behaviors Assessed by Items on Physical Activity

Special Diets in the past year

Special Diets in the past two weeks

Natural Products in the past year

Natural products in the past two weeks

Mind/body therapies in the past year

Mind/body therapies in the past two weeks

Personal prayer in past year

Personal prayer in the past two weeks

Other stress support in the past year

Other stress support in the past two weeks

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

Health Behaviors Assessed by Items on Use of Complementary Health Approaches

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.

Spots Global Cancer Trial Database for Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial