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| ID | Type | Description | Link |
|---|---|---|---|
| 5KL2TR001421-04 | U.S. NIH Grant/Contract | View source | |
| WFBCCC 99519 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this research is to determine feasibility and acceptability of randomized pilot trial to evaluate a technology-based intervention (CONNECT) to empower and educate caregivers about the benefits of supportive care resources, identify their unmet needs, and connect them with resources.
The registration is for Objective two and three that refers to the clinical trial. The investigators will determine their ability to recruit caregivers of patients with head and neck cancer being treated at Wake Forest Baptist Comprehensive Cancer Center to a study that uses a technology-based intervention, CONNECT, which may increase head and neck cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. In this study the investigators also want to look at their ability to recruit a control group of caregivers, that is, caregivers of patients with head and neck cancer being treated at Wake Forest Baptist Comprehensive Cancer Center that will receive a list of supportive care resources. Control groups are used in research to see if the intervention being studied really does have an effect. In addition, the investigators will determine whether or not the intervention has led to improvements in caregivers' use of supportive care resources, quality of care, and overall quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONNECT Intervention Group - Group A | Other | A web-based intervention (CONNECT) to empower and connect caregivers of newly diagnosed cancer patients to supportive care resources A randomized pilot study will be conducted to assess feasibility and acceptability and obtain data on caregiver and patient outcomes. CONNECT e-tool, re-education and optional referral (2 weeks post CONNECT e-tool). Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. |
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| CONNECT Comparison Group - Group B | Other | Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONNECT | Behavioral | A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Caregivers Who Agree to Participate | Number of caregivers who agreed to participate divided by the number of months of recruitment | 19 months |
| Number of Eligible Participants | Number of eligible participants who agreed to participate | 9 months |
| Number of Retention of Participants | Number of participants who completed the T2 assessment divided by the number who agreed to participate | 9 months |
| Acceptability - (Intervention Arm Only) | Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a ~30min (approximately) qualitative interview to further explore acceptability (measures were not at all helpful, a little helpful, somewhat helpful or quite a bit helpful). | 9 months |
| Acceptability - (Intervention Arm Only) | Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a ~30min (approximately) qualitative interview to further explore acceptability (measures were strongly agree, agree and undecided). | 9 months |
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| Measure | Description | Time Frame |
|---|---|---|
| SF-12 Patient Measures - Physical/Emotional Well-being | A 12-item instrument measuring physical and mental well-being, though our analyses will focus on physical well-being; widely used in oncology populations. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
Inclusion Criteria:
Eligible caregivers include those who are:
Eligible patients include those who:
Exclusion Criteria:
Caregivers will be excluded if:
• Cannot read/communicate in English
Patients will be excluded if they:
• Cannot read/communicate in English
Eligibility to participate in the study is conditional on participation of both the caregiver and patient.
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| Name | Affiliation | Role |
|---|---|---|
| Chandylen Nightingale, PhD, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CONNECT Intervention Group - Group A | A web-based intervention (CONNECT) to empower and connect caregivers of newly diagnosed cancer patients to supportive care resources A randomized pilot study will be conducted to assess feasibility and acceptability and obtain data on caregiver and patient outcomes. CONNECT e-tool, re-education and optional referral (2 weeks post CONNECT e-tool). Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONNECT: A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources. |
| FG001 | CONNECT Comparison Group - Group B | Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONTROL: This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CONNECT Intervention Group - Group A | A web-based intervention (CONNECT) to empower and connect caregivers of newly diagnosed cancer patients to supportive care resources A randomized pilot study will be conducted to assess feasibility and acceptability and obtain data on caregiver and patient outcomes. CONNECT e-tool, re-education and optional referral (2 weeks post CONNECT e-tool). Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONNECT: A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Caregivers Who Agree to Participate | Number of caregivers who agreed to participate divided by the number of months of recruitment | The 40 participants that agreed to participate in the intervention were accrued over a total of 19 months. | Posted | Number | participants per month | 19 months |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CONNECT Intervention Group - Group A | A web-based intervention (CONNECT) to empower and connect caregivers of newly diagnosed cancer patients to supportive care resources A randomized pilot study will be conducted to assess feasibility and acceptability and obtain data on caregiver and patient outcomes. CONNECT e-tool, re-education and optional referral (2 weeks post CONNECT e-tool). Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONNECT: A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Wake Forest Baptist Comprehensive Cancer Center | 336-713-0677 | radellin@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2021 | Feb 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2021 | Feb 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| CONTROL | Behavioral | This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address. |
|
| 1 year |
| Unplanned Healthcare Utilization Survey | Unplanned healthcare utilization survey will be calculated using a one item continuous score. The survey will capture patient self-reported unplanned healthcare utilization (number of unplanned visits to the emergency room, urgent care, or healthcare provider) from time points of baseline to end of treatment. | 1 year |
| FAMCARE Questionnaire (Patient) | A 20-item instrument with 4 subscales to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Participants will answer questions to indicate how satisfied they are with care family member has received. (Subscales = (S) satisfied, (U) undecided, (D) dissatisfied or (VD) very dissatisfied | 1 year |
| PROMIS Emotional Distress-Anxiety-Short Form 8a for Patients | An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations | 1 year |
| PROMIS Emotional Distress- Depression-Short Form 8a for Patients | An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose.Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety. | 1 year |
| Patient - Quality of Life Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) | A 39-item instrument that measures physical, social, emotional, and functional well-being, as well as additional head and neck-related concerns. Scoring scale is 0 = not at all to 4 = very much). Maximum score of 156. Higher scores indicate a better quality of life. | 1 year |
| Supportive Care Utilization | Adapted version of the 28-item Consumer-Based Cancer Care Value Index- Services and Resources instrument assessing use of services to meet multidimensional supportive needs. Intervention caregivers will also self-report service use by completing an auto-generated REDCap survey to query about utilization of the specific resources that each caregiver expressed interest in accessing. | 1 year |
| FAMCARE Questionnaire (Caregiver) | A 20-item instrument with 4 subscales to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Participants will answer questions to indicate how satisfied they are with care family member has received. (Subscales = (S) satisfied, (U) undecided, (D) dissatisfied or (VD) very dissatisfied | 1 year |
| Caregiver Reaction Assessment | Caregiver Reaction Assessment - 24-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Each item is rated on a 1 to 4 scale. 1 (not at all) 2 (somewhat) 3 (quite a bit) 4 (completely) | 1 year |
| PROMIS Emotional Distress-Anxiety-Short Form 8a | An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety. | 1 year |
| PROMIS Emotional Distress- Depression-Short Form 8a | An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. | 1 year |
| Caregiver Quality of Life Index-Cancer (CqoL-Canc) | 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). Scoring scale is 0 = not at all to 4 = very much). Maximum score of 140. Higher scores indicate better quality of life. | 1 year |
| Caregiver Risk Scale | A 7-item measure to assess caregiver behaviors for managing self-care. Questions are answered Yes or No and is a summation of the number of risks. Score range of 0-7, the higher the number, the greater the risk. | 1 year |
| Caregiver Adherence to Referral Survey | Survey responses will be coded as "adhered" or "did not adhere" for agency- and caregiver- reported service utilization. The score reporting is a dichotomous outcome of an adhered or not adhered. | 1 year |
| Caregiving Self-Efficacy Scale | 21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions). Uses a likert scale from 1 (not at all confident) to 9 (totally confident). Higher scores indicate higher self-efficacy for coping with cancer. | 1 year |
| Barriers to Supportive Care Use Survey | A 16-item survey with an additional "other" category for a caregiver to report additional barriers not noted on the survey. Response options range from never (0) to always (4). Higher scores indicate a greater number of barriers. | 1 year |
| BG001 | CONNECT Comparison Group - Group B | Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONTROL: This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Some College Education | Count of Participants | Participants |
|
| Married/ Partnered to Patient | Count of Participants | Participants |
|
| Adult Children to Patient | Count of Participants | Participants |
|
| Partnered. Married | Count of Participants | Participants |
|
|
| Primary | Number of Eligible Participants | Number of eligible participants who agreed to participate | Out of 108 participants found to be eligible to participate in the study intervention only 40 agreed and consented to begin the study intervention. | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Primary | Number of Retention of Participants | Number of participants who completed the T2 assessment divided by the number who agreed to participate | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Primary | Acceptability - (Intervention Arm Only) | Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a ~30min (approximately) qualitative interview to further explore acceptability (measures were not at all helpful, a little helpful, somewhat helpful or quite a bit helpful). | The acceptability measures were obtained from only 1 arm (intervention arm, since the questions pertain to the acceptability of the intervention), and were asked at the final time point, which means the n is those left in the intervention arm at the last time point. | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Primary | Acceptability - (Intervention Arm Only) | Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a ~30min (approximately) qualitative interview to further explore acceptability (measures were strongly agree, agree and undecided). | The acceptability measures were obtained from only 1 arm (intervention arm, since the questions pertain to the acceptability of the intervention), and were asked at the final time point, which means the n is those left in the intervention arm at the last time point. | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Other Pre-specified | SF-12 Patient Measures - Physical/Emotional Well-being | A 12-item instrument measuring physical and mental well-being, though our analyses will focus on physical well-being; widely used in oncology populations. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Not Posted | 1 year | Participants |
| Other Pre-specified | Unplanned Healthcare Utilization Survey | Unplanned healthcare utilization survey will be calculated using a one item continuous score. The survey will capture patient self-reported unplanned healthcare utilization (number of unplanned visits to the emergency room, urgent care, or healthcare provider) from time points of baseline to end of treatment. | Not Posted | 1 year | Participants |
| Other Pre-specified | FAMCARE Questionnaire (Patient) | A 20-item instrument with 4 subscales to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Participants will answer questions to indicate how satisfied they are with care family member has received. (Subscales = (S) satisfied, (U) undecided, (D) dissatisfied or (VD) very dissatisfied | Not Posted | 1 year | Participants |
| Other Pre-specified | PROMIS Emotional Distress-Anxiety-Short Form 8a for Patients | An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations | Not Posted | 1 year | Participants |
| Other Pre-specified | PROMIS Emotional Distress- Depression-Short Form 8a for Patients | An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose.Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety. | Not Posted | 1 year | Participants |
| Other Pre-specified | Patient - Quality of Life Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) | A 39-item instrument that measures physical, social, emotional, and functional well-being, as well as additional head and neck-related concerns. Scoring scale is 0 = not at all to 4 = very much). Maximum score of 156. Higher scores indicate a better quality of life. | Not Posted | 1 year | Participants |
| Other Pre-specified | Supportive Care Utilization | Adapted version of the 28-item Consumer-Based Cancer Care Value Index- Services and Resources instrument assessing use of services to meet multidimensional supportive needs. Intervention caregivers will also self-report service use by completing an auto-generated REDCap survey to query about utilization of the specific resources that each caregiver expressed interest in accessing. | Not Posted | 1 year | Participants |
| Other Pre-specified | FAMCARE Questionnaire (Caregiver) | A 20-item instrument with 4 subscales to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Participants will answer questions to indicate how satisfied they are with care family member has received. (Subscales = (S) satisfied, (U) undecided, (D) dissatisfied or (VD) very dissatisfied | Not Posted | 1 year | Participants |
| Other Pre-specified | Caregiver Reaction Assessment | Caregiver Reaction Assessment - 24-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Each item is rated on a 1 to 4 scale. 1 (not at all) 2 (somewhat) 3 (quite a bit) 4 (completely) | Not Posted | 1 year | Participants |
| Other Pre-specified | PROMIS Emotional Distress-Anxiety-Short Form 8a | An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety. | Not Posted | 1 year | Participants |
| Other Pre-specified | PROMIS Emotional Distress- Depression-Short Form 8a | An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. | Not Posted | 1 year | Participants |
| Other Pre-specified | Caregiver Quality of Life Index-Cancer (CqoL-Canc) | 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). Scoring scale is 0 = not at all to 4 = very much). Maximum score of 140. Higher scores indicate better quality of life. | Not Posted | 1 year | Participants |
| Other Pre-specified | Caregiver Risk Scale | A 7-item measure to assess caregiver behaviors for managing self-care. Questions are answered Yes or No and is a summation of the number of risks. Score range of 0-7, the higher the number, the greater the risk. | Not Posted | 1 year | Participants |
| Other Pre-specified | Caregiver Adherence to Referral Survey | Survey responses will be coded as "adhered" or "did not adhere" for agency- and caregiver- reported service utilization. The score reporting is a dichotomous outcome of an adhered or not adhered. | Not Posted | 1 year | Participants |
| Other Pre-specified | Caregiving Self-Efficacy Scale | 21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions). Uses a likert scale from 1 (not at all confident) to 9 (totally confident). Higher scores indicate higher self-efficacy for coping with cancer. | Not Posted | 1 year | Participants |
| Other Pre-specified | Barriers to Supportive Care Use Survey | A 16-item survey with an additional "other" category for a caregiver to report additional barriers not noted on the survey. Response options range from never (0) to always (4). Higher scores indicate a greater number of barriers. | Not Posted | 1 year | Participants |
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | CONNECT Comparison Group - Group B | Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONTROL: This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address. | 0 | 22 | 0 | 22 | 0 | 22 |
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| Somewhat helpful |
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| Quite a bit helpful |
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| Online survey to identify the types of resources/services that might be helpful as a caregiver |
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| List of supportive care resources |
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| Referral option immediately upon completing the survey to identify resource interest |
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| 2 week follow up phone call to discuss available resources |
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