Caregiver, Malignant Head and Neck Neoplasm, Paranasal Sinus Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal SCC, Recurrent Paranasal Sinus Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage I Hypopharyngeal Squamous Cell Carcinoma, Stage II Hypopharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma, Stage III Laryngeal Squamous Cell Carcinoma, Stage III Lip and Oral Cavity Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma, Stage II Laryngeal Squamous Cell Carcinoma, Stage II Lip and Oral Cavity Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage I Laryngeal Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Squamous Cell Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage IVA Hypopharyngeal Squamous Cell Carcinoma, Stage IVA Laryngeal Squamous Cell Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Hypopharyngeal Squamous Cell Carcinoma, Stage IVB Laryngeal Squamous Cell Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Hypopharyngeal Squamous Cell Carcinoma, Stage IVC Laryngeal Squamous Cell Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Stage IV Hypopharyngeal Squamous Cell Carcinoma, Stage IV Laryngeal Squamous Cell Carcinoma, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma, Stage IV Oropharyngeal Squamous Cell Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Attend interventionist sessions
Watch video on a DVD
Complete modules of the Prepare to Care kit
Ancillary studies
Ancillary studies
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.
Sponsors
Study design
Eligibility
Inclusion criteria
CAREGIVERS: * Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study CARE-RECIPIENTS: * Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers) * Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks * Has an informal (unpaid) caregiver during radiation therapy who is participating in study
Exclusion criteria
* CAREGIVERS: Has a current cancer diagnosis * CAREGIVERS: Cannot read/communicate in English * CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study * CARE-RECIPIENTS: Cannot read/communicate in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy in Coping With Cancer Caregiver Inventory | At baseline and up to the end of radiotherapy, assessed up to 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); 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. |
| Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Six weeks post radiation therapy | 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. |
| Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment | Up to 1 year | 38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month |
| Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Baseline and following radiotherapy, assessed up to 1 year | 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. |
| Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) | Before and after radiotherapy, assessed up to 1 year | 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. |
| Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) | Before and after radiotherapy, assessed up to 1 year | 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. |
| Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Up to 1 year | Data on intervention resources used and time spent using them based on caregivers in intervention group |
| Number of Participants in Agreement to Perform Interventions | Up to 1 year | Participation assessed by number of eligible participants who agreed to participate and complete study interventions. |
| 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) | At baseline and up to the end of radiotherapy, assessed up to 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Collection | Up to 1 year | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | Group I Supportive Care (Prepare to Care Kit) | Total | Group II Control Group |
|---|---|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 15.5 | 56.4 years STANDARD_DEVIATION 13.6 | 57.4 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 34 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 29 Participants | 13 Participants |
| Region of Enrollment United States | 17 participants | 35 participants | 18 participants |
| Sex: Female, Male Female | 17 Participants | 21 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 14 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
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
Time frame: Up to 1 year
Population: 38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment | 1.7 participants/months |
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.
Time frame: Baseline and following radiotherapy, assessed up to 1 year
Population: Not all participants submitted information after completion of radiotherapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Esteem at baseline | 25.98 score on a scale | Standard Deviation 3.6 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Lack of family support at baseline | 11.29 score on a scale | Standard Deviation 2.69 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on finances at baseline | 8.29 score on a scale | Standard Deviation 2.28 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Esteem after radiotherapy | 25.75 score on a scale | Standard Deviation 3.31 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on schedule at baseline | 17.35 score on a scale | Standard Deviation 3.31 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on health at baseline | 13.94 score on a scale | Standard Deviation 1.48 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Lack of family support after radiotherapy | 12.58 score on a scale | Standard Deviation 2.23 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on finances after radiotherapy | 8.42 score on a scale | Standard Deviation 1.16 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on schedule after radiotherapy | 18.33 score on a scale | Standard Deviation 2.74 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on health after radiotherapy | 14.33 score on a scale | Standard Deviation 1.61 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on health after radiotherapy | 14.38 score on a scale | Standard Deviation 1.59 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Esteem at baseline | 25.88 score on a scale | Standard Deviation 3.8 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on schedule at baseline | 16.78 score on a scale | Standard Deviation 4.1 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on health at baseline | 13.67 score on a scale | Standard Deviation 1.65 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Esteem after radiotherapy | 25.30 score on a scale | Standard Deviation 4.19 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Lack of family support at baseline | 11.25 score on a scale | Standard Deviation 2.67 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Lack of family support after radiotherapy | 11.19 score on a scale | Standard Deviation 3.23 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on finances at baseline | 8.89 score on a scale | Standard Deviation 1.78 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on schedule after radiotherapy | 16.56 score on a scale | Standard Deviation 4.43 |
| Group II No Interventionist Sessions | Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) | Impact on finances after radiotherapy | 8.25 score on a scale | Standard Deviation 1.24 |
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.
Time frame: Before and after radiotherapy, assessed up to 1 year
Population: Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) | Score at baseline | 19.71 score on a scale | Standard Deviation 13.05 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) | Score after radiotherapy | 19.00 score on a scale | Standard Deviation 15.66 |
| Group II No Interventionist Sessions | Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) | Score at baseline | 19.28 score on a scale | Standard Deviation 12.97 |
| Group II No Interventionist Sessions | Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) | Score after radiotherapy | 13.58 score on a scale | Standard Deviation 8.65 |
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.
Time frame: Before and after radiotherapy, assessed up to 1 year
Population: Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) | At baseline | 87.63 score on a scale | Standard Deviation 25.95 |
| Group I Supportive Care (Prepare to Care Kit) | Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) | After radiotherapy | 92.55 score on a scale | Standard Deviation 22.09 |
| Group II No Interventionist Sessions | Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) | At baseline | 87.26 score on a scale | Standard Deviation 20.32 |
| Group II No Interventionist Sessions | Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) | After radiotherapy | 89.86 score on a scale | Standard Deviation 18.78 |
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
Time frame: Up to 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Cancer Education | 22.3 Minutes | Standard Deviation 10.2 |
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Utilizing Resources | 38.7 Minutes | Standard Deviation 20.1 |
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Seeking/ Accepting Support | 55.2 Minutes | Standard Deviation 27.8 |
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Communicating with others | 40.3 Minutes | Standard Deviation 12.7 |
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Managing Time | 40.8 Minutes | Standard Deviation 26.9 |
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Coping | 66.7 Minutes | Standard Deviation 51.1 |
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Practicing Healthy Behaviors | 48 Minutes | Standard Deviation 15.6 |
| Group I Supportive Care (Prepare to Care Kit) | Frequency of Intervention Modules Utilized Assessed by Caregiver Logs | Relaxation CD | 58 Minutes | Standard Deviation 18.1 |
Number of Participants in Agreement to Perform Interventions
Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
Time frame: Up to 1 year
Population: 90 eligible patient/caregiver dyads, 38 agreed to participate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants in Agreement to Perform Interventions | 38 Participants |
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.
Time frame: Six weeks post radiation therapy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Weekly email reminders | 4 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Study website | 0 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Utilizing Resources workbook | 7 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Managing Time workbook | 7 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Muscle Relaxation workbook | 7 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Introductory DVD | 4 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Meetings with study interventionist | 6 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Relaxation CD | 7 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Weekly text reminders | 6 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Clinic iPads | 0 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Cancer Education workbook | 9 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Seeking/Accepting Support workbook | 7 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Communicating with Others workbook | 7 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Healthy Behaviors workbook | 7 Participants |
| Group I Supportive Care (Prepare to Care Kit) | Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions | Positive Coping workbook | 7 Participants |
Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
Time frame: Up to 1 year
Population: 38 agreed to participate (19 in caregiver intervention group, 19 in caregiver control group)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate | 12 Participants |
| Group II No Interventionist Sessions | Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate | 16 Participants |
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.
Time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) | At baseline | 11.88 score on a scale | Standard Deviation 6.53 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) | After radiotherapy | 16.08 score on a scale | Standard Deviation 2.68 |
| Group II No Interventionist Sessions | Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) | At baseline | 13.33 score on a scale | Standard Deviation 5.36 |
| Group II No Interventionist Sessions | Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) | After radiotherapy | 12.19 score on a scale | Standard Deviation 5.59 |
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.
Time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing medical information at baseline | 22.35 score on a scale | Standard Deviation 3.26 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for care recipient at baseline | 52.94 score on a scale | Standard Deviation 9.65 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for oneself at baseline | 25.71 score on a scale | Standard Deviation 10.44 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing difficult interactions/emotions at baseline | 34.52 score on a scale | Standard Deviation 10.96 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing medical information after radiotherapy | 23.08 score on a scale | Standard Deviation 2.54 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for care recipient after radiotherapy | 54.42 score on a scale | Standard Deviation 5.62 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for oneself after radiotherapy | 25.75 score on a scale | Standard Deviation 9.4 |
| Group I Supportive Care (Prepare to Care Kit) | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing difficult interactions/emotions after radiotherapy | 37.92 score on a scale | Standard Deviation 10.03 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing difficult interactions/emotions after radiotherapy | 39.68 score on a scale | Standard Deviation 7.86 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing medical information at baseline | 22.00 score on a scale | Standard Deviation 3.29 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing medical information after radiotherapy | 22.43 score on a scale | Standard Deviation 4.8 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for care recipient at baseline | 55.11 score on a scale | Standard Deviation 6.11 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for oneself after radiotherapy | 31.30 score on a scale | Standard Deviation 8.26 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for oneself at baseline | 28.06 score on a scale | Standard Deviation 7.83 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Caring for care recipient after radiotherapy | 54.98 score on a scale | Standard Deviation 6.82 |
| Group II No Interventionist Sessions | Self-efficacy in Coping With Cancer Caregiver Inventory | Managing difficult interactions/emotions at baseline | 39.13 score on a scale | Standard Deviation 7.95 |
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
Time frame: Up to 1 year
Population: Analysis of this outcome measure is currently incomplete and cannot be reported as this time as the information is not available.