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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-02045 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 99616 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| R03CA208560 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.
PRIMARY OBJECTIVES:
I. To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).
II. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).
III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.
IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I Supportive Care (Prepare to Care kit) | Experimental | Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. |
|
| Group II Control Group | Experimental | Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication Intervention | Other | Attend interventionist sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | 10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure. | Six weeks post radiation therapy |
| Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment | 38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month | Up to 1 year |
| Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | 21-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. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant. | Baseline and following radiotherapy, assessed up to 1 year |
| Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) | The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed. | Before and after radiotherapy, assessed up to 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Salivary Cortisol Collection | For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3 |
Inclusion Criteria:
CAREGIVERS:
CARE-RECIPIENTS:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandylen Nightingale | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35575280 | Derived | Nightingale C, Sterba KR, Levine B, Tooze JA, Greven K, Frizzell B, Hughes RT, Snavely A, Lesser GJ, Norona S, Pleasant K, Weaver KE. Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221098984. doi: 10.1177/15347354221098984. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I Supportive Care (Prepare to Care Kit) | Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 4, 2019 |
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| Watch video | Other | Watch video on a DVD |
|
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| Module completion of the Prepare to Care kit | Other | Complete modules of the Prepare to Care kit |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Survey Administration | Other | Ancillary studies |
|
| Salivary cortisol collection | Other | Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
|
| Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) | 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants. | Before and after radiotherapy, assessed up to 1 year |
| Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Data on intervention resources used and time spent using them based on caregivers in intervention group | Up to 1 year |
| Number of Participants in Agreement to Perform Interventions | Participation assessed by number of eligible participants who agreed to participate and complete study interventions. | Up to 1 year |
| Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate | Up to 1 year |
| Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) | A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants. | At baseline and up to the end of radiotherapy, assessed up to 1 year |
| Self-efficacy in Coping With Cancer Caregiver Inventory | 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); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants. | At baseline and up to the end of radiotherapy, assessed up to 1 year |
| Up to 1 year |
| FG001 | Group II Control Group | Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study. Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I Supportive Care (Prepare to Care Kit) | Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
| BG001 | Group II Control Group | Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study." Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | 10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure. | Posted | Count of Participants | Participants | Six weeks post radiation therapy |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment | 38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month | 38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month | Posted | Number | participants/months | Up to 1 year |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | 21-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. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant. | Not all participants submitted information after completion of radiotherapy. | Posted | Mean | Standard Deviation | score on a scale | Baseline and following radiotherapy, assessed up to 1 year |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) | The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed. | Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure | Posted | Mean | Standard Deviation | score on a scale | Before and after radiotherapy, assessed up to 1 year |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) | 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants. | Not all participants completed this intervention after radiotherapy as indicated for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Before and after radiotherapy, assessed up to 1 year |
| |||||||||||||||||||||||||||||||||||||
| Primary | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Data on intervention resources used and time spent using them based on caregivers in intervention group | Posted | Mean | Standard Deviation | Minutes | Up to 1 year |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants in Agreement to Perform Interventions | Participation assessed by number of eligible participants who agreed to participate and complete study interventions. | 90 eligible patient/caregiver dyads, 38 agreed to participate | Posted | Count of Participants | Participants | Up to 1 year |
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| |||||||||||||||||||||||||||||||||||||
| Primary | Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate | 38 agreed to participate (19 in caregiver intervention group, 19 in caregiver control group) | Posted | Count of Participants | Participants | Up to 1 year |
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| Primary | Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) | A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants. | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to the end of radiotherapy, assessed up to 1 year |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Self-efficacy in Coping With Cancer Caregiver Inventory | 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); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants. | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to the end of radiotherapy, assessed up to 1 year |
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| Other Pre-specified | Salivary Cortisol Collection | For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3 | Analysis of this outcome measure is currently incomplete and cannot be reported as this time as the information is not available. | Posted | Up to 1 year |
|
6 weeks
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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 | Group I Supportive Care (Prepare to Care Kit) | Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | Group II Control Group | Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study. Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Wake Forest Baptist Comprehensive Cancer Center | 336-713-1432 | cnightin@wakehealth.edu |
| Apr 19, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Caregiver Informed Consent | Mar 19, 2018 | Apr 19, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Informed Consent | Mar 19, 2018 | Apr 19, 2021 | ICF_002.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| C562489 | Lymphoid Interstitial Pneumonia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Weekly text reminders |
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| Weekly email reminders |
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| Study website |
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| Clinic iPads |
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| Cancer Education workbook |
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| Utilizing Resources workbook |
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| Managing Time workbook |
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| Seeking/Accepting Support workbook |
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| Communicating with Others workbook |
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| Healthy Behaviors workbook |
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| Positive Coping workbook |
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| Muscle Relaxation workbook |
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| Participants |
|
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| OG001 | Group II No Interventionist Sessions | Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
|
|
|
|
| OG001 |
| Group II No Interventionist Sessions |
Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
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Caregivers receive educational intervention as in Group I but do not attend interventionist sessions
Watch video: Watch video on a DVD
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
|
|
| OG001 | Group II Control Group | Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. |
|