Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
NCT03032250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2023-01-09
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.
Conditions
- Caregiver
- 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 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
- 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
Interventions
- OTHER
-
Communication Intervention
Attend interventionist sessions
- OTHER
-
Watch video
Watch video on a DVD
- OTHER
-
Module completion of the Prepare to Care kit
Complete modules of the Prepare to Care kit
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Survey Administration
Ancillary studies
- OTHER
-
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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Chandylen Nightingale · Wake Forest University Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-15
- Primary Completion
- 2020-04-10
- Completion
- 2020-04-10
Countries
- United States
Study Locations
More Related Trials
-
Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
NCT03030859 ·Status: COMPLETED ·Phase: NA
-
Cardiopulmonary Fitness in Long-Term Survivors of HPV-related Oropharynx Cancers
NCT02628912 ·Status: WITHDRAWN
-
Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
NCT02296684 ·Status: COMPLETED ·Phase: PHASE2
-
Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
NCT00002964 ·Status: COMPLETED ·Phase: PHASE2
-
The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy
NCT05457478 ·Status: TERMINATED ·Phase: NA
-
Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer
NCT04572100 ·Status: COMPLETED ·Phase: PHASE1
-
2 Phase Use Of Educational Materials In Head And Neck Cancer Center
NCT02204631 ·Status: COMPLETED ·Phase: NA
-
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
NCT02388932 ·Status: TERMINATED ·Phase: NA
-
App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
NCT06367257 ·Status: RECRUITING ·Phase: NA
-
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
NCT03952585 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer
NCT05544136 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT01484847 ·Status: COMPLETED ·Phase: NA
-
Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
NCT00002922 ·Status: COMPLETED ·Phase: PHASE2
-
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
NCT04858269 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
NCT06005324 ·Status: RECRUITING ·Phase: PHASE1
-
A Web-Based Multimedia Intervention for Head and Neck Cancer Patients
NCT02442336 ·Status: COMPLETED ·Phase: NA
-
Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
NCT07121595 ·Status: RECRUITING ·Phase: PHASE2
-
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
NCT07195734 ·Status: RECRUITING ·Phase: PHASE2
-
Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer
NCT00544414 ·Status: COMPLETED ·Phase: PHASE2
-
S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
NCT00095641 ·Status: WITHDRAWN ·Phase: PHASE2
-
Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer
NCT06775756 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition
NCT04454489 ·Status: COMPLETED ·Phase: PHASE2
-
Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck
NCT01952821 ·Status: COMPLETED
-
Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
NCT06223568 ·Status: RECRUITING ·Phase: PHASE2
-
SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
NCT00095628 ·Status: COMPLETED ·Phase: PHASE2