Cancer, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Survivorship
Conditions
Brief summary
The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.
Detailed description
Primary Objectives: • To evaluate how successfully SHARE-S can be implemented into clinical care as characterized by rates of enrollment. Investigators hypothesize \>30% of patients e-referred to SHARE-S will enroll. Secondary Objectives: * To assess additional implementation outcomes that evaluate preliminary implementation success (i.e., further assessment of adoption, acceptability, appropriateness, further assessment of feasibility, and fidelity). * To describe service outcome variability to inform future studies. Investigators will assess service outcomes relevant to Commission on Cancer requirements by reporting annual estimates for: (1) the estimated number of patients impacted by SHARE-S; (2) the cancer sites impacted by SHARE-S; and the (3) resources/processes utilized to enhance each of the chosen services if barriers were encountered. We will also assess safety and perceived patient-centeredness of care. * To describe patient health outcome variability to inform future studies (i.e., social role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain, cancer-specific quality of life, health behaviors, patient autonomy, self-efficacy for managing cancer, engagement with the survivorship care plan document, and satisfaction with care). * To evaluate the Implementation Program we will assess key milestones and processes for this pilot study of the Implementation Stage measured at the clinic level. * To qualitatively assess implementation barriers and facilitators using semi-structured interviews that will be audio-recorded. * To examine how study results vary by cancer type.
Interventions
BEHAVIORALSHARE-S Implementation Program
The program consists of three components: An electronic referral among clinical teams for potential participants, patient engagement with survivorship care planning guidelines through self-management/health coaching. One coaching call before a clinic visit (60 minutes) and two coaching calls after the clinic visit (30 minutes each). Participants will also receive automated, tailored text messages (daily for three weeks before and after a clinic visit for a total of six weeks).
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years of age * Documented or planned cancer survivorship visit * Have a texting enabled telephone * Cognitively able to complete study procedures as judged by the study team * Able to understand, read and write English Children under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. Results from this research may inform future studies in children with cancer under 18 who should be researched separately.
Exclusion criteria
\- Declined participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Enrolled Out of Those Electronically Referred | 1 year, 8 months | Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure | Up to 30 days after the final intervention session. | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability. |
| Appropriateness of Intervention Measure | Up to 30 days after the final intervention session. | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness. |
| Number of Participants Enrolled Per Month | 1 year, 8 months | This will be defined as the average number of participants that enroll per month that the study is open to enrollment. |
| Feasibility of Intervention Measure | Up to 30 days after the final intervention session. | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility. |
| Retention Rates | Up to 30 days after the final intervention session. | Retention is defined as participants that complete the follow up assessment. |
| Number of Participants Adhering to Text Responses | 1 year, 8 months | Defined as participants that adhere to responding to text messages received during intervention. |
| Participant Adherence to Coaching Sessions | 1 year, 8 months | Defined as adherence to completing coaching sessions during the intervention. |
| Length of Coaching Sessions | Up to 30 days after the final intervention session. | Defined as how long each completed coaching sessions lasted during the intervention. |
| Number of Coaching Sessions Completed | 1 year, 8 months | Defined as an observational checklist completed for a subset of coaching sessions. |
| Total Number of Patients Enrolled | 1 year, 8 months | Number of patients enrolled will be defined as overall participants for the entirety of the study. |
| Frequency of Adverse Events | Up to 30 days after the final intervention session. | Adverse events related to the intervention will be assessed in adverse event log. |
| HEAL Patient-Provider Connection | Up to 30 days after the final intervention session. | Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication. |
| Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review] | 1 year, 8 months | Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S |
| 36-Item Short Form Survey (SF-36) | At baseline and up to 30 days after the final intervention session. | Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health. |
| Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | At baseline and up to 30 days after the final intervention session. | Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings. |
| Index of Autonomous Functioning - Self Congruence Subscale Only | At baseline and up to 30 days after the final intervention session. | The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = not at all true, 2 = a bit true, 3 = somewhat true, 4 = mostly true, and 5 = completely true. Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning. |
| Self-Efficacy to Manage Chronic Disease Questionnaire | At baseline and up to 30 days after the final intervention session. | A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy. |
| Engagement With the Survivorship Care Plan | 1 year, 8 months | Self-reported use of the care plan since enrolled on the study. |
| Satisfaction of Care | Up to 30 days after the final intervention session. | Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good. |
| Health Behaviors Questionnaire - Tobacco Use | At baseline and up to 30 days after the final intervention session. | Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users. |
| Health Behaviors Questionnaire - Alcohol Use Disorder | At baseline and up to 30 days after the final intervention session. | Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous. |
| Health Behaviors Questionnaire - Physical Activity | At baseline and up to 30 days after the final intervention session. | Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with \<90 minutes considered insufficient. |
| Health Behaviors Questionnaire - Fruit and Vegetable Intake | At baseline and up to 30 days after the final intervention session. | Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient. |
| Health Behaviors Questionnaire - Mindfulness Practice | At baseline and up to 30 days after the final intervention session. | Participants will be asked individual questions how many days/week they practice mindfulness. |
| Patient-Reported Health Outcomes PROMIS Profile 29 | At baseline and up to 30 days after the final intervention session. | Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Intervention | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 15.7 |
| BMI, Continuous | 32.2 Kg/m^2 STANDARD_DEVIATION 6.8 |
| Confident filling out medical forms, Categorical A little bit | 0 Participants |
| Confident filling out medical forms, Categorical Extremely | 27 Participants |
| Confident filling out medical forms, Categorical Not at all | 0 Participants |
| Confident filling out medical forms, Categorical Quite a bit | 11 Participants |
| Confident filling out medical forms, Categorical Somewhat | 2 Participants |
| Difficult to pay monthly bills, Categorical Not at all difficult | 14 Participants |
| Difficult to pay monthly bills, Categorical Not very difficult | 16 Participants |
| Difficult to pay monthly bills, Categorical Somewhat difficult | 8 Participants |
| Difficult to pay monthly bills, Categorical Very difficult | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Highest Grade, Categorical 8th to 11th grade | 1 Participants |
| Highest Grade, Categorical Associate's degree/some college | 8 Participants |
| Highest Grade, Categorical Bachelor's degree | 17 Participants |
| Highest Grade, Categorical Graduate or professional school | 8 Participants |
| Highest Grade, Categorical High school or equivalent | 5 Participants |
| Highest Grade, Categorical Vocation/technical school post HS | 1 Participants |
| History of Cancer-Related Surgical Procedure, Categorical No | 15 Participants |
| History of Cancer-Related Surgical Procedure, Categorical Yes | 25 Participants |
| History of Chemotherapy, Categorical No | 22 Participants |
| History of Chemotherapy, Categorical Yes | 18 Participants |
| History of Radiation Therapy, Categorical No | 12 Participants |
| History of Radiation Therapy, Categorical Yes | 28 Participants |
| Marital Status, Categorical Currently Married | 28 Participants |
| Marital Status, Categorical Divorced | 3 Participants |
| Marital Status, Categorical Prefer not to answer | 1 Participants |
| Marital Status, Categorical Separated | 1 Participants |
| Marital Status, Categorical Single, never married | 5 Participants |
| Marital Status, Categorical Widowed | 2 Participants |
| Number of times received income assistance, Categorical Four times | 0 Participants |
| Number of times received income assistance, Categorical More than four times | 1 Participants |
| Number of times received income assistance, Categorical Never | 30 Participants |
| Number of times received income assistance, Categorical Once | 4 Participants |
| Number of times received income assistance, Categorical Three times | 1 Participants |
| Number of times received income assistance, Categorical Twice | 4 Participants |
| Primary Tumor Site, Categorical Breast | 18 Participants |
| Primary Tumor Site, Categorical Colorectal | 1 Participants |
| Primary Tumor Site, Categorical Endometrial | 3 Participants |
| Primary Tumor Site, Categorical Non-Hodgkin Lymphoma | 1 Participants |
| Primary Tumor Site, Categorical Other | 7 Participants |
| Primary Tumor Site, Categorical Prostate | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Rural residence, Categorical No | 35 Participants |
| Rural residence, Categorical Yes | 5 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 11 Participants |
| Time since last treatment/surgery (months) | 5 months |
| Travel to clinic bills (minutes) | 31.5 minutes STANDARD_DEVIATION 28.6 |
| Use internet or email at least occasionally, Categorical No | 2 Participants |
| Use internet or email at least occasionally, Categorical Yes | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Number of Patients Enrolled Out of Those Electronically Referred
Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.
Time frame: 1 year, 8 months
Population: Total number reflects the total number of participants who were electronically referred in SHARE-S intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SHARE-S Intervention | Number of Patients Enrolled Out of Those Electronically Referred | 40 number of participants |
p-value: 0.54Independent samples proportions test
Secondary
36-Item Short Form Survey (SF-36)
Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: 40 enrolled at baseline; 35 answered follow-up questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | 36-Item Short Form Survey (SF-36) | 3.15 score on a scale | Standard Deviation 0.83 |
| SHARE-S Intervention - Follow-Up | 36-Item Short Form Survey (SF-36) | 3.15 score on a scale | Standard Deviation 0.89 |
Secondary
Acceptability of Intervention Measure
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability.
Time frame: Up to 30 days after the final intervention session.
Population: Initial cohort less 6 lost to follow-up at time of subsequent survey administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Acceptability of Intervention Measure | 4.4 score on a scale | Standard Deviation 0.6 |
Secondary
Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]
Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S
Time frame: 1 year, 8 months
Population: Total number given a care plan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-S Intervention | Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review] | 118 Participants |
Secondary
Appropriateness of Intervention Measure
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness.
Time frame: Up to 30 days after the final intervention session.
Population: Initial cohort less 6 lost to follow-up at time of subsequent survey administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Appropriateness of Intervention Measure | 4.3 score on a scale | Standard Deviation 0.6 |
Secondary
Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire
Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: 40 participants at baseline; 35 participants answered follow-up questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHARE-S Intervention | Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Cancer-Specific Quality of Life | 47 score on a scale | Standard Deviation 20.5 |
| SHARE-S Intervention | Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Benefits of Having Cancer | 13.9 score on a scale | Standard Deviation 5.8 |
| SHARE-S Intervention | Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Positive Feelings | 10.6 score on a scale | Standard Deviation 5.4 |
| SHARE-S Intervention - Follow-Up | Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Cancer-Specific Quality of Life | 40.9 score on a scale | Standard Deviation 19.1 |
| SHARE-S Intervention - Follow-Up | Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Benefits of Having Cancer | 12.2 score on a scale | Standard Deviation 5.7 |
| SHARE-S Intervention - Follow-Up | Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Positive Feelings | 9.5 score on a scale | Standard Deviation 4.3 |
Secondary
Engagement With the Survivorship Care Plan
Self-reported use of the care plan since enrolled on the study.
Time frame: 1 year, 8 months
Population: 34 participants available at follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-S Intervention | Engagement With the Survivorship Care Plan | 34 Participants |
Secondary
Feasibility of Intervention Measure
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility.
Time frame: Up to 30 days after the final intervention session.
Population: Initial cohort less 6 lost to follow-up at time of subsequent survey administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Feasibility of Intervention Measure | 4.3 score on a scale | Standard Deviation 0.5 |
Secondary
Frequency of Adverse Events
Adverse events related to the intervention will be assessed in adverse event log.
Time frame: Up to 30 days after the final intervention session.
Population: 40 participants enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SHARE-S Intervention | Frequency of Adverse Events | 0 events |
Secondary
HEAL Patient-Provider Connection
Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication.
Time frame: Up to 30 days after the final intervention session.
Population: Initial cohort with 6 lost to follow-up at time of subsequent survey administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | HEAL Patient-Provider Connection | 32.3 score on a scale | Standard Deviation 4.2 |
Secondary
Health Behaviors Questionnaire - Alcohol Use Disorder
Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: Entire cohort at baseline; 34 participants at follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Health Behaviors Questionnaire - Alcohol Use Disorder | 1.4 score on a scale | Standard Deviation 1.9 |
| SHARE-S Intervention - Follow-Up | Health Behaviors Questionnaire - Alcohol Use Disorder | 1.2 score on a scale | Standard Deviation 1.6 |
Secondary
Health Behaviors Questionnaire - Fruit and Vegetable Intake
Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: Entire cohort at baseline; 34 participants at follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Health Behaviors Questionnaire - Fruit and Vegetable Intake | 2.7 cups/day | Standard Deviation 1.2 |
| SHARE-S Intervention - Follow-Up | Health Behaviors Questionnaire - Fruit and Vegetable Intake | 3.2 cups/day | Standard Deviation 1.6 |
Secondary
Health Behaviors Questionnaire - Mindfulness Practice
Participants will be asked individual questions how many days/week they practice mindfulness.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: Entire cohort at baseline; 34 participants at follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Health Behaviors Questionnaire - Mindfulness Practice | 1.8 days/week | Standard Deviation 2.1 |
| SHARE-S Intervention - Follow-Up | Health Behaviors Questionnaire - Mindfulness Practice | 3.4 days/week | Standard Deviation 2.1 |
Secondary
Health Behaviors Questionnaire - Physical Activity
Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with \<90 minutes considered insufficient.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: Entire cohort at baseline; 34 participants at follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Health Behaviors Questionnaire - Physical Activity | 124.5 minutes/week | Standard Deviation 140 |
| SHARE-S Intervention - Follow-Up | Health Behaviors Questionnaire - Physical Activity | 162.4 minutes/week | Standard Deviation 157.2 |
Secondary
Health Behaviors Questionnaire - Tobacco Use
Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: 40 participants at baseline; 34 participants answered follow-up questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-S Intervention | Health Behaviors Questionnaire - Tobacco Use | 1 Participants |
| SHARE-S Intervention - Follow-Up | Health Behaviors Questionnaire - Tobacco Use | 1 Participants |
Secondary
Index of Autonomous Functioning - Self Congruence Subscale Only
The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = not at all true, 2 = a bit true, 3 = somewhat true, 4 = mostly true, and 5 = completely true. Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: 40 participants at baseline; 35 participants answered follow-up questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Index of Autonomous Functioning - Self Congruence Subscale Only | 4.3 score on a scale | Standard Deviation 0.5 |
| SHARE-S Intervention - Follow-Up | Index of Autonomous Functioning - Self Congruence Subscale Only | 4.3 score on a scale | Standard Deviation 0.6 |
Secondary
Length of Coaching Sessions
Defined as how long each completed coaching sessions lasted during the intervention.
Time frame: Up to 30 days after the final intervention session.
Population: 40 enrolled (mean minutes over coach calls at 3 timepoints).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SHARE-S Intervention | Length of Coaching Sessions | 39 minutes |
Secondary
Number of Coaching Sessions Completed
Defined as an observational checklist completed for a subset of coaching sessions.
Time frame: 1 year, 8 months
Population: 40 enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SHARE-S Intervention | Number of Coaching Sessions Completed | 111 sessions |
Secondary
Number of Participants Adhering to Text Responses
Defined as participants that adhere to responding to text messages received during intervention.
Time frame: 1 year, 8 months
Population: 40 enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-S Intervention | Number of Participants Adhering to Text Responses | 27 Participants |
Secondary
Number of Participants Enrolled Per Month
This will be defined as the average number of participants that enroll per month that the study is open to enrollment.
Time frame: 1 year, 8 months
Population: Number enrolled per month.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SHARE-S Intervention | Number of Participants Enrolled Per Month | 2 participants/month |
Secondary
Participant Adherence to Coaching Sessions
Defined as adherence to completing coaching sessions during the intervention.
Time frame: 1 year, 8 months
Population: 40 enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-S Intervention | Participant Adherence to Coaching Sessions | 36 Participants |
Secondary
Patient-Reported Health Outcomes PROMIS Profile 29
Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: 40 enrolled at baseline; 35 available at follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | physical function (0-100) | 48.4 score on a scale | Standard Deviation 8.2 |
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | anxiety (0-100) | 50.6 score on a scale | Standard Deviation 9.8 |
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | depression (0-100) | 48.1 score on a scale | Standard Deviation 9.3 |
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | fatigue (0-100) | 51.3 score on a scale | Standard Deviation 10.9 |
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | sleep disturbance (0-100) | 49.6 score on a scale | Standard Deviation 7.4 |
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | social roles (0-100) | 51.2 score on a scale | Standard Deviation 9.4 |
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | pain interference (0-100) | 51.5 score on a scale | Standard Deviation 10.2 |
| SHARE-S Intervention | Patient-Reported Health Outcomes PROMIS Profile 29 | pain intensity (0-10) | 2.7 score on a scale | Standard Deviation 2.4 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | pain intensity (0-10) | 2.5 score on a scale | Standard Deviation 2.4 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | physical function (0-100) | 49.2 score on a scale | Standard Deviation 8.5 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | sleep disturbance (0-100) | 48.9 score on a scale | Standard Deviation 6.3 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | anxiety (0-100) | 49.0 score on a scale | Standard Deviation 8.5 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | pain interference (0-100) | 50.3 score on a scale | Standard Deviation 9.3 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | depression (0-100) | 45.9 score on a scale | Standard Deviation 7.7 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | social roles (0-100) | 54.2 score on a scale | Standard Deviation 10.8 |
| SHARE-S Intervention - Follow-Up | Patient-Reported Health Outcomes PROMIS Profile 29 | fatigue (0-100) | 49.2 score on a scale | Standard Deviation 11.5 |
Secondary
Retention Rates
Retention is defined as participants that complete the follow up assessment.
Time frame: Up to 30 days after the final intervention session.
Population: SHARE-S Intervention enrolled participants less 5 lost in follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-S Intervention | Retention Rates | 35 Participants |
Secondary
Satisfaction of Care
Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good.
Time frame: Up to 30 days after the final intervention session.
Population: Follow-up only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Satisfaction of Care | 4.8 score on a scale | Standard Deviation 0.4 |
Secondary
Self-Efficacy to Manage Chronic Disease Questionnaire
A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy.
Time frame: At baseline and up to 30 days after the final intervention session.
Population: 40 participants at baseline; 35 participants answered follow-up questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHARE-S Intervention | Self-Efficacy to Manage Chronic Disease Questionnaire | 7.7 score on a scale | Standard Deviation 1.8 |
| SHARE-S Intervention - Follow-Up | Self-Efficacy to Manage Chronic Disease Questionnaire | 7.8 score on a scale | Standard Deviation 1.9 |
Secondary
Total Number of Patients Enrolled
Number of patients enrolled will be defined as overall participants for the entirety of the study.
Time frame: 1 year, 8 months
Population: 40 participants enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-S Intervention | Total Number of Patients Enrolled | 40 Participants |