Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Caregiver
  • Head and Neck Neoplasms
  • Malignant Head and Neck Neoplasm
  • Paranasal Sinus Squamous Cell Carcinoma
  • Recurrence
  • 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
  • Squamous Cell Carcinoma of Head and Neck
  • 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 II Oropharyngeal 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

NCT number NCT03032250
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase N/A
Start date May 15, 2017
Completion date April 10, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03671226 - Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center N/A
Active, not recruiting NCT03287492 - RCT of QPS vs General Information Sheet N/A
Completed NCT06269276 - Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
Completed NCT03675217 - Physical Exercise Program for Family Caregivers of Dependent Patients N/A
Not yet recruiting NCT05970471 - Preferences of Patients Treated With Oral Cancer Drugs and Informal Caregivers for Pharmaceutical Consultation in Hospital
Completed NCT04587583 - WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers Phase 1/Phase 2
Completed NCT03689179 - Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use N/A
Enrolling by invitation NCT05068765 - The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers N/A
Completed NCT05441384 - It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy N/A
Active, not recruiting NCT03267524 - Walking for Recovery From Surgery in Improving Quality of Life in Older Adults With Lung or Gastrointestinal Cancer and Their Family Caregivers N/A
Active, not recruiting NCT03686007 - Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients N/A
Completed NCT02603367 - COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer N/A
Completed NCT04747210 - Contextual Coaching Versus Training Workshop for Assistants in Special Education. N/A
Completed NCT04058886 - Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers N/A
Completed NCT03775616 - Financial Navigation Program Intervention in Supporting Patients With Solid Tumors and Their Caregivers N/A
Completed NCT03528863 - Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers N/A
Completed NCT06132022 - The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Care N/A
Not yet recruiting NCT06111794 - The REACH Intervention for Caregivers of Veterans and Service Members With TBI N/A
Withdrawn NCT04085081 - Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers N/A
Not yet recruiting NCT05245305 - The Effect of Mindfulness-Based Stress Reduction Program N/A