Advanced Cancer
Conditions
Keywords
cancer, caregiver, videoconferencing
Brief summary
This study seeks to test the effectiveness of two arms of an intervention that use videoconference technology for distance caregivers of patients with advanced cancer. The study is significant because the intervention will promote involvement of caregivers of patients with cancer and makes a compelling case for significance based on changing demographics and lifestyles.
Detailed description
The primary goal of this randomized clinical trial is to compare outcomes (anxiety, distress, depression, health status) for distant care givers (DCGs) of patients with advanced cancer who are randomly assigned to either the full intervention arm (Closer), the video-only intervention arm (Video-C Only) or the control group (Web-Only). the goal is to determine which is most efficacious in improving outcomes over time for these caregivers. In addition, this study will examine the indirect effects of each arm of the intervention on DCG outcomes over time as well as explore the nature of relationships between patient and DCG distress, anxiety and depression over time. The specific research questions include: 1. Is there a difference in DCG outcomes (anxiety, distress, depression, health status) over time between caregivers in the Closer, Video-C Only, and Web-Only groups, controlling for DCG demographic variables? 2. Are there significant indirect effects of Closer, Video-C Only, and Web-Only on DCG outcomes (anxiety, distress, depression, health status) over time, controlling for DCG demographic variables? 3. Are there significant relationships between DCG distress, anxiety, depression and health status and patient distress, anxiety and depression over time?
Interventions
BEHAVIORALVideo-C
use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
BEHAVIORALNurse Coaching
structured conversations with registered nurses aimed at providing emotional support
BEHAVIORALWeb-Only
Access to a website with caregiving resources, resources for distant care givers, and cancer information
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
Study personnel administering questionnaire and follow-up questions with participants will be blinded to the arm assignment of the participant
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient Inclusion Criteria: * a new diagnosis (within 3 months) of advanced cancer and/or patients receiving ongoing care from a medical oncologist (solid tumors) or a new recurrence of the primary cancer in an advanced stage * receives ongoing care from a medical oncologist at the Seidman Cancer Center * Has English as the primary language * Has a life expectancy of \>6 months * Provides consent for his/her own treatment and procedures * Identifies a distant care giver (DCG) involved in his/her care, support or planning Patient
Exclusion criteria
* The patient sample is limited to patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist because the full intervention is tailored to meet the needs of DCGs of patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist Caregiver Inclusion Criteria * Is an adult family member (at least 18 years old) of a patient with an advanced-stage cancer * Identifies himself/herself as a DCG for the patient * Lives \>1 hour travel time away from the patient * Has English as his/her primary language * Is capable of providing informed consent * Will be able to access the internet (phone, computer, etc.) Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety T-scores | At enrollment to end of intervention period (4 months) | Compare the direct effects of Closer, Video-C Only, and Web-Only on anxiety over time, controlling for DCG demographic variables. Anxiety will be measured using the 4-item tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety. The PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 37.1 to 83.1 with higher t-scores representing more anxiety. The mean and standard deviation are as follows: M=50 (SD=10). T-scores from 55-60 represent mild anxiety, 61-70 moderate anxiety and \> 70 represent severe anxiety. |
| Change in Distress Scores | At enrollment to end of intervention period (4 months) | Compare the direct effects of Closer, Video-C Only, and Web-Only on distress over time, controlling for DCG demographic variables. Distress is conceptually defined as a negative state in which coping and adaptation processes fail to return the individual to physiological and/or psychological homeostasis. It will be measured using the National Comprehensive Cancer Network (NCCN) distress thermometer - a clinical tool currently utilized with the cancer population. The National Comprehensive Cancer Network Distress Thermometer is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment. Scores range from 0 to 10 with higher scores representing higher levels of distress. Scores \>4 indicate distress requiring further evaluation. |
| Change in Depression T-scores | At enrollment to end of intervention period (4 months) | Compare the direct effects of Closer, Video-C Only, and Web-Only on depression over time, controlling for DCG demographic variables. Depression will be measured using the 4 item PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a. The PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 38.2 to 81.3 with higher t-scores representing worse depression. T-scores from 55-60 represent mild depression, 61-70 moderate depression and \> 70 represent severe depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Closer The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in real time during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support | 103 |
| Video-C Only This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be delivered systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in real time during a minimum of four office visits over the 4-month study period (total dose \
5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers | 106 |
| Web-Only This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association, etc.), b)Resources for DCGs (links to the Caregiving from a Distance, etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.
Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information | 93 |
| Total | 302 |
Baseline characteristics
| Characteristic | Total | Web-Only | Video-C Only | Closer |
|---|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 12.9 | 46.8 years STANDARD_DEVIATION 12.4 | 45.9 years STANDARD_DEVIATION 12.7 | 47.7 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 1 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 240 Participants | 73 Participants | 86 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 55 Participants | 19 Participants | 19 Participants | 17 Participants |
| NCCN distress thermometer | 4.25 units on a scale STANDARD_DEVIATION 2.57 | 4.55 units on a scale STANDARD_DEVIATION 2.39 | 4.00 units on a scale STANDARD_DEVIATION 2.68 | 4.23 units on a scale STANDARD_DEVIATION 2.61 |
| PROMISR SFv1.0-ED-anxiety-SF8a | 55.09 T-scores STANDARD_DEVIATION 7.7 | 56.03 T-scores STANDARD_DEVIATION 8.21 | 54.68 T-scores STANDARD_DEVIATION 7.14 | 54.66 T-scores STANDARD_DEVIATION 7.77 |
| PROMISR SFv1.0-ED-depression-SF8a | 50.64 T-scores STANDARD_DEVIATION 7.76 | 52.28 T-scores STANDARD_DEVIATION 7.42 | 50.16 T-scores STANDARD_DEVIATION 7.92 | 49.64 T-scores STANDARD_DEVIATION 7.73 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 80 Participants | 29 Participants | 18 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 210 Participants | 60 Participants | 85 Participants | 65 Participants |
| Region of Enrollment United States | 302 participants | 93 participants | 106 participants | 103 participants |
| Sex: Female, Male Female | 223 Participants | 73 Participants | 75 Participants | 75 Participants |
| Sex: Female, Male Male | 79 Participants | 20 Participants | 31 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 106 | 0 / 93 |
| other Total, other adverse events | 0 / 103 | 0 / 106 | 0 / 93 |
| serious Total, serious adverse events | 0 / 103 | 0 / 106 | 0 / 93 |
Outcome results
Primary
Change in Anxiety T-scores
Compare the direct effects of Closer, Video-C Only, and Web-Only on anxiety over time, controlling for DCG demographic variables. Anxiety will be measured using the 4-item tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety. The PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 37.1 to 83.1 with higher t-scores representing more anxiety. The mean and standard deviation are as follows: M=50 (SD=10). T-scores from 55-60 represent mild anxiety, 61-70 moderate anxiety and \> 70 represent severe anxiety.
Time frame: At enrollment to end of intervention period (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closer | Change in Anxiety T-scores | 53.14 T-score | Standard Deviation 8.14 |
| Video-C Only | Change in Anxiety T-scores | 55.47 T-score | Standard Deviation 7.67 |
| Web-Only | Change in Anxiety T-scores | 56.85 T-score | Standard Deviation 8.73 |
p-value: 0.16295% CI: [-5.051, 0.55]ANCOVA
p-value: 0.00795% CI: [-6.538, -0.789]ANCOVA
p-value: 0.71495% CI: [-4.29, 1.464]ANCOVA
Primary
Change in Depression T-scores
Compare the direct effects of Closer, Video-C Only, and Web-Only on depression over time, controlling for DCG demographic variables. Depression will be measured using the 4 item PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a. The PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 38.2 to 81.3 with higher t-scores representing worse depression. T-scores from 55-60 represent mild depression, 61-70 moderate depression and \> 70 represent severe depression.
Time frame: At enrollment to end of intervention period (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closer | Change in Depression T-scores | 49.29 T-score | Standard Deviation 8 |
| Video-C Only | Change in Depression T-scores | 50.72 T-score | Standard Deviation 7.89 |
| Web-Only | Change in Depression T-scores | 52.62 T-score | Standard Deviation 8.75 |
p-value: 0.32395% CI: [-2.939, 0.971]ANCOVA
p-value: 0.08695% CI: [-3.785, 0.249]ANCOVA
p-value: 0.44395% CI: [-2.794, 1.226]ANCOVA
Primary
Change in Distress Scores
Compare the direct effects of Closer, Video-C Only, and Web-Only on distress over time, controlling for DCG demographic variables. Distress is conceptually defined as a negative state in which coping and adaptation processes fail to return the individual to physiological and/or psychological homeostasis. It will be measured using the National Comprehensive Cancer Network (NCCN) distress thermometer - a clinical tool currently utilized with the cancer population. The National Comprehensive Cancer Network Distress Thermometer is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment. Scores range from 0 to 10 with higher scores representing higher levels of distress. Scores \>4 indicate distress requiring further evaluation.
Time frame: At enrollment to end of intervention period (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closer | Change in Distress Scores | 3.37 score on a scale | Standard Deviation 2.8 |
| Video-C Only | Change in Distress Scores | 3.89 score on a scale | Standard Deviation 2.64 |
| Web-Only | Change in Distress Scores | 4.86 score on a scale | Standard Deviation 2.66 |
p-value: 0.17395% CI: [-1.297, 0.234]ANCOVA
p-value: 0.00195% CI: [-2.241, -0.671]ANCOVA
p-value: 0.02195% CI: [-1.711, -0.139]ANCOVA