Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers

Conditions
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Caregiver, Stage II Oropharyngeal Squamous Cell Carcinoma, Malignant Head and Neck Neoplasm, Paranasal Sinus Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage I Hypopharyngeal 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 II Hypopharyngeal Squamous Cell Carcinoma, Stage II Laryngeal Squamous Cell Carcinoma, Stage II Lip and Oral Cavity 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 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, 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, 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

Intervention / Treatment
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* Other: Communication Intervention
* Other: Watch video
* Other: Module completion of the Prepare to Care kit
* Other: Quality-of-Life Assessment
* Other: Survey Administration
* Other: Salivary cortisol collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I Supportive Care (Prepare to Care kit)<br>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. | Other: Communication Intervention<br>* Attend interventionist sessions<br>Other: Watch video<br>* Watch video on a DVD<br>* Other names: Intervention, Educational;Other: Module completion of the Prepare to Care kit<br>* Complete modules of the Prepare to Care kit<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>Other: Salivary cortisol collection<br>* 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.<br>|
| Experimental: Group II Control Group<br>Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study | Other: Watch video<br>* Watch video on a DVD<br>* Other names: Intervention, Educational;Other: Module completion of the Prepare to Care kit<br>* Complete modules of the Prepare to Care kit<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>Other: Salivary cortisol collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |