Cancer Survivor, Stage I Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Conditions
Brief 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. Behavioral interventions, such as systems support mapping, may help colorectal cancer survivors facilitate self-awareness, create motivation for behavior change, and guide self-management.
Detailed description
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.
Interventions
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
BEHAVIORALSystem Support Mapping
Complete MAP
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | 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. |
| Participation Rate | 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. |
| Retention Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form | 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. |
| PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection | 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. |
| Psychological Stress Assessed by Perceived Stress Scale | 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. |
| Qualitative Assessment of Acceptability With Semi-structured Interviews | 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. |
| Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29 | 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. |
| Self-reported Ratings of Intervention Acceptability | 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. |
| Qualitative Assessment of Feasibility With Semi-structured Interviews | 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. |
| Qualitative Analysis of Systems Support Maps | 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. |
| Health Behaviors Assessed by Items on Physical Activity | 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. |
| Health Behaviors Assessed by Items on Use of Complementary Health Approaches | 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. |
| Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews | 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. |
| Health Behaviors Assessed by Items on Tobacco Use | 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. |
| Measures of Autonomy Assessed by Index of Autonomous Functioning | 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. |
| Self-efficacy for Managing Cancer - Chronic Disease Scale | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 66 people were approached to participate in this study. Only 24 were enrolled, 42 declined participation.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Participants Baseline characteristics of study participants that actually participated in study interventions. | 24 |
| Declined Participants Baseline characteristics of potential participants that declined participation | 42 |
| Total | 66 |
Baseline characteristics
| Characteristic | Total | Enrolled Participants | Declined Participants |
|---|---|---|---|
| Age, Continuous | 63.90 Years STANDARD_DEVIATION 13.49 | 60.91 Years STANDARD_DEVIATION 15.7 | 66.9 Years STANDARD_DEVIATION 11.29 |
| Cancer Type Colon cancer | 17 Participants | 17 Participants | — |
| Cancer Type Rectal cancer | 7 Participants | 7 Participants | — |
| Confident in Filling Out Medical Forms (Health Literacy) Extremely/Quite a Bit | 20 Participants | 20 Participants | — |
| Confident in Filling Out Medical Forms (Health Literacy) Somewhat/A Little Bit/Not at all | 3 Participants | 3 Participants | — |
| Difficulty Paying Monthly Bills Not at all diffcult | 5 Participants | 5 Participants | — |
| Difficulty Paying Monthly Bills Not very difficult | 11 Participants | 11 Participants | — |
| Difficulty Paying Monthly Bills Very/somewhat difficult | 6 Participants | 6 Participants | — |
| Education Level College graduate/Post graduate degree | 11 Participants | 11 Participants | — |
| Education Level Less than high school/High school graduate | 3 Participants | 3 Participants | — |
| Education Level Technical school/Some college | 9 Participants | 9 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 22 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Marital Status Married or Living with Partner | 13 Participants | 13 Participants | — |
| Marital Status Separated/Divorced | 2 Participants | 2 Participants | — |
| Marital Status Widowed/Single | 8 Participants | 8 Participants | — |
| Minutes Traveled to Clinic | 34 minutes | 34 minutes | — |
| Months Since Last Cancer Treatment | 9 months | 9 months | — |
| Number of Comorbidities (Range 0-14) | 1 median of comorbidities of participants | 1 median of comorbidities of participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 20 Participants | 37 Participants |
| Received Chemotherapy No | 7 Participants | 7 Participants | — |
| Received Chemotherapy Yes | 17 Participants | 17 Participants | — |
| Received Radiation No | 15 Participants | 15 Participants | — |
| Received Radiation Yes | 9 Participants | 9 Participants | — |
| Recurrent Disease No | 24 Participants | 24 Participants | — |
| Recurrent Disease Yes | 0 Participants | 0 Participants | — |
| Region of Enrollment United States | 66 participants | 24 participants | 42 participants |
| Rural Residence as Defined by Federal Office of Rural Health Policy (FORHP) Not living in a rural residence | 19 Participants | 19 Participants | — |
| Rural Residence as Defined by Federal Office of Rural Health Policy (FORHP) Rural Residence as defined by FORHP | 5 Participants | 5 Participants | — |
| Sex: Female, Male Female | 37 Participants | 15 Participants | 22 Participants |
| Sex: Female, Male Male | 29 Participants | 9 Participants | 20 Participants |
| Summary Disease Stage at Diagnosis Stage I | 5 Participants | 5 Participants | — |
| Summary Disease Stage at Diagnosis Stage II | 7 Participants | 7 Participants | — |
| Summary Disease Stage at Diagnosis Stage III | 12 Participants | 12 Participants | — |
| Times Received Income from AFDC, TANF, Work First, WIC or food stamps Four times or less | 3 Participants | 3 Participants | — |
| Times Received Income from AFDC, TANF, Work First, WIC or food stamps More than four times | 1 Participants | 1 Participants | — |
| Times Received Income from AFDC, TANF, Work First, WIC or food stamps Never | 19 Participants | 19 Participants | — |
| Underwent Surgery No | 1 Participants | 1 Participants | — |
| Underwent Surgery Yes | 23 Participants | 23 Participants | — |
| Use of Internet or Email No | 2 Participants | 2 Participants | — |
| Use of Internet or Email Yes | 22 Participants | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 2 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
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.
Time frame: Up to 1 year
Population: Out of 66 participants asked to participate, only 24 were eligible/enrolled into the intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrollment Rate - Eligible Participants | Enrollment Rate | 0.36 Percent probability of participants |
Primary
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrollment Rate - Eligible Participants | Participation Rate | 0.88 percentage of completed intervention |
Primary
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enrollment Rate - Eligible Participants | Retention Rate | 0.83 proportion of completed study measures |
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Physical Activity | Rarely or never do any physical activity - At two weeks | 3 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Physical Activity | Light physical activity every week - Baseline | 16 Participants |
| Enrollment Rate - Eligible 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 |
| Enrollment Rate - Eligible 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 |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Physical Activity | Rarely or never do any physical activity - Baseline | 3 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Physical Activity | Do some light/moderate physical activity but not every week - Baseline | 7 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Physical Activity | Do some light/moderate physical activity but not every week - At two weeks | 4 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Physical Activity | Light physical activity every week - At two weeks | 15 Participants |
| Enrollment Rate - Eligible 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 |
| Enrollment Rate - Eligible 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 |
| Enrollment Rate - Eligible 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 |
| Enrollment Rate - Eligible 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 |
| Enrollment Rate - Eligible 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 |
| Enrollment Rate - Eligible 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
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Tobacco Use | Ever-smokers | 6 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Tobacco Use | Never smokers | 18 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Tobacco Use | Last cigarette more than 1 year ago prior to baseline survey | 6 Participants |
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Special Diets in the past year | 3 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Special Diets in the past two weeks | 3 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Natural Products in the past year | 4 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Natural products in the past two weeks | 4 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Mind/body therapies in the past year | 8 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Mind/body therapies in the past two weeks | 5 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Personal prayer in past year | 14 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Personal prayer in the past two weeks | 12 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Other stress support in the past year | 1 Participants |
| Enrollment Rate - Eligible Participants | Health Behaviors Assessed by Items on Use of Complementary Health Approaches | Other stress support in the past two weeks | 2 Participants |
Secondary
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Rate - Eligible Participants | Measures of Autonomy Assessed by Index of Autonomous Functioning | Baseline | 4.4 score on a scale | Standard Deviation 0.6 |
| Enrollment Rate - Eligible Participants | Measures of Autonomy Assessed by Index of Autonomous Functioning | Two weeks | 4.7 score on a scale | Standard Deviation 0.4 |
| Enrollment Rate - Eligible Participants | Measures of Autonomy Assessed by Index of Autonomous Functioning | Difference in time points | 0.4 score on a scale | Standard Deviation 0.6 |
Secondary
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enrollment Rate - Eligible Participants | PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection | 66.2 score on a scale | Standard Deviation 7.5 |
Secondary
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Rate - Eligible Participants | Psychological Stress Assessed by Perceived Stress Scale | Baseline | 8.1 score on a scale | Standard Deviation 1.9 |
| Enrollment Rate - Eligible Participants | Psychological Stress Assessed by Perceived Stress Scale | Two weeks | 6.7 score on a scale | Standard Deviation 2.9 |
| Enrollment Rate - Eligible Participants | Psychological Stress Assessed by Perceived Stress Scale | Difference in both time points | -1.0 score on a scale | Standard Deviation 2.2 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrollment Rate - Eligible Participants | Qualitative Analysis of Systems Support Maps | 21 Participants |
Secondary
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.
Time frame: Up to 1 year
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrollment Rate - Eligible Participants | Qualitative Assessment of Acceptability With Semi-structured Interviews | 19 Participants |
Secondary
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.
Time frame: Up to 1 year
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrollment Rate - Eligible Participants | Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews | 19 Participants |
Secondary
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrollment Rate - Eligible Participants | Qualitative Assessment of Feasibility With Semi-structured Interviews | 19 Participants |
Secondary
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Rate - Eligible Participants | Self-efficacy for Managing Cancer - Chronic Disease Scale | Baseline | 7.7 score on a scale | Standard Deviation 2.1 |
| Enrollment Rate - Eligible Participants | Self-efficacy for Managing Cancer - Chronic Disease Scale | Two weeeks | 8.6 score on a scale | Standard Deviation 1.5 |
| Enrollment Rate - Eligible Participants | 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
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.
Time frame: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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
Self-reported Ratings of Intervention Acceptability
Descriptive statistics will be used to summarize participant ratings of acceptability of intervention.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrollment Rate - Eligible Participants | Self-reported Ratings of Intervention Acceptability | Liked the intervention quite a bit/very much | 16 Participants |
| Enrollment Rate - Eligible Participants | Self-reported Ratings of Intervention Acceptability | Liked the intervention a little bit/somewhat | 4 Participants |
| Enrollment Rate - Eligible Participants | Self-reported Ratings of Intervention Acceptability | Found intervention helpful very much/quite a bit | 15 Participants |
| Enrollment Rate - Eligible Participants | Self-reported Ratings of Intervention Acceptability | Found intervention helpful a little bit/somewhat | 5 Participants |
| Enrollment Rate - Eligible Participants | Self-reported Ratings of Intervention Acceptability | Would continue to use what they learned quite a bit/very much | 18 Participants |
| Enrollment Rate - Eligible Participants | Self-reported Ratings of Intervention Acceptability | Would continue to use what they learned a little bit/somewhat | 2 Participants |
| Enrollment Rate - Eligible Participants | Self-reported Ratings of Intervention Acceptability | Found interventionist competent and sensitive quite a bit/very much | 20 Participants |
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |
| Enrollment Rate - Eligible Participants | 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 |