Head and Neck Cancer
Conditions
Keywords
Head and Neck Cancer Caregivers
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCONNECT
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.
BEHAVIORALCONTROL
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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligible caregivers include those who are: * Caregivers must be providing some capacity of informal (unpaid) care for a patient meeting patient eligibility criteria. If a patient unexpectedly becomes deceased during the study period, caregivers will be allowed to continue participation in the assigned study arm and complete study assessments if they wish to. * Greater than or equal to 18 years of age. * Ability to access study materials by internet or complete study activities in person as institutional and government policies allow. Eligible patients include those who: * Have new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV head and neck cancer. * Are receiving cancer treatment or awaiting planned treatment initiation, excluding those receiving neoadjuvant surgery or surgery only. * Patients must be ambulatory and up more than 50% of waking hours, as measured by an ECOG Performance Status rating of level 0, 1, or 2. * Greater than or equal to 18 years of age. * Ability to access study materials by internet or complete study activities in person as institutional and government policies allow. * Patients must be receiving some capacity of informal care from a caregiver meeting the above criteria. If the caregiver unexpectedly becomes deceased during the study period, the patient will be un-enrolled from this study as we are evaluating a caregiver-only delivered intervention.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Caregivers Who Agree to Participate | 19 months | Number of caregivers who agreed to participate divided by the number of months of recruitment |
| Number of Eligible Participants | 9 months | Number of eligible participants who agreed to participate |
| Number of Retention of Participants | 9 months | Number of participants who completed the T2 assessment divided by the number who agreed to participate |
| Acceptability - (Intervention Arm Only) | 9 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Emotional Distress- Depression-Short Form 8a for Patients | 1 year | 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. |
| Patient - Quality of Life Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) | 1 year | 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. |
| Supportive Care Utilization | 1 year | 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. |
| FAMCARE Questionnaire (Caregiver) | 1 year | 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 |
| Caregiver Reaction Assessment | 1 year | 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) |
| PROMIS Emotional Distress-Anxiety-Short Form 8a | 1 year | 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. |
| SF-12 Patient Measures - Physical/Emotional Well-being | 1 year | 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. |
| Caregiver Quality of Life Index-Cancer (CqoL-Canc) | 1 year | 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. |
| Caregiver Risk Scale | 1 year | 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. |
| Caregiver Adherence to Referral Survey | 1 year | 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. |
| Caregiving Self-Efficacy Scale | 1 year | 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. |
| Barriers to Supportive Care Use Survey | 1 year | 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. |
| PROMIS Emotional Distress- Depression-Short Form 8a | 1 year | 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. |
| Unplanned Healthcare Utilization Survey | 1 year | 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. |
| FAMCARE Questionnaire (Patient) | 1 year | 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 |
| PROMIS Emotional Distress-Anxiety-Short Form 8a for Patients | 1 year | An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 22 |
| Total | 40 |
Baseline characteristics
| Characteristic | CONNECT Intervention Group - Group A | CONNECT Comparison Group - Group B | Total |
|---|---|---|---|
| Adult Children to Patient | 5 Participants | 2 Participants | 7 Participants |
| Age, Customized Age 18-35 | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized Age 36-54 | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized Age 55-72 | 5 Participants | 3 Participants | 8 Participants |
| Age, Customized Age unknown | 11 Participants | 18 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 19 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Married/ Partnered to Patient | 12 Participants | 16 Participants | 28 Participants |
| Partnered. Married | 13 Participants | 19 Participants | 32 Participants |
| Region of Enrollment United States | 18 Participants | 22 Participants | 40 Participants |
| Sex: Female, Male Female | 14 Participants | 20 Participants | 34 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
| Some College Education | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 0 / 18 | 0 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
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).
Time frame: 9 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Accrual | Acceptability - (Intervention Arm Only) | Strongly Agree | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Agree | 7 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Undecided | 5 Participants |
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).
Time frame: 9 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Accrual | Acceptability - (Intervention Arm Only) | Online survey to identify the types of resources/services that might be helpful as a caregiver | Not at all helpful | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | List of supportive care resources | Somewhat helpful | 5 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | List of supportive care resources | Quite a bit helpful | 3 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Educational video on the CONNECT website (step 1 in guide) | Quite a bit helpful | 3 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Educational video on the CONNECT website (step 1 in guide) | Not at all helpful | 1 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Educational video on the CONNECT website (step 1 in guide) | A little helpful | 3 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | List of supportive care resources | A little helpful | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Educational video on the CONNECT website (step 1 in guide) | Somewhat helpful | 5 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Online survey to identify the types of resources/services that might be helpful as a caregiver | A little helpful | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Online survey to identify the types of resources/services that might be helpful as a caregiver | Somewhat helpful | 4 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Online survey to identify the types of resources/services that might be helpful as a caregiver | Quite a bit helpful | 4 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | List of supportive care resources | Not at all helpful | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Referral option immediately upon completing the survey to identify resource interest | Not at all helpful | 1 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Referral option immediately upon completing the survey to identify resource interest | A little helpful | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Referral option immediately upon completing the survey to identify resource interest | Somewhat helpful | 7 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | Referral option immediately upon completing the survey to identify resource interest | Quite a bit helpful | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | 2 week follow up phone call to discuss available resources | Not at all helpful | 1 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | 2 week follow up phone call to discuss available resources | A little helpful | 2 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | 2 week follow up phone call to discuss available resources | Somewhat helpful | 6 Participants |
| Accrual | Acceptability - (Intervention Arm Only) | 2 week follow up phone call to discuss available resources | Quite a bit helpful | 1 Participants |
Primary
Number of Eligible Participants
Number of eligible participants who agreed to participate
Time frame: 9 months
Population: Out of 108 participants found to be eligible to participate in the study intervention only 40 agreed and consented to begin the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Accrual | Number of Eligible Participants | 40 Participants |
Primary
Number of Retention of Participants
Number of participants who completed the T2 assessment divided by the number who agreed to participate
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Accrual | Number of Retention of Participants | 32 Participants |
Primary
Proportion of Caregivers Who Agree to Participate
Number of caregivers who agreed to participate divided by the number of months of recruitment
Time frame: 19 months
Population: The 40 participants that agreed to participate in the intervention were accrued over a total of 19 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Accrual | Proportion of Caregivers Who Agree to Participate | 2.1 participants per month |
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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)
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year