Caregiver Clinical Trial
Official title:
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
| Verified date | December 2022 |
| Source | Wake Forest University Health Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | April 10, 2020 |
| Est. primary completion date | April 10, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | Up to 1 year | |
| 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. | 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 | 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. | 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. | 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. | 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 | 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. | Up to 1 year | |
| Primary | 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 | ||
| 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. | 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. | At baseline and up to the end of radiotherapy, assessed up to 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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