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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032250
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
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 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : April 10, 2020
Actual Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Communication Intervention
Attend interventionist sessions

Other: Watch video
Watch video on a DVD
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Module completion of the Prepare to Care kit
Complete modules of the Prepare to Care kit
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.

Experimental: Group II No interventionist sessions
Caregivers receive educational intervention as in Group I but do not attend interventionist sessions
Other: Watch video
Watch video on a DVD
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Module completion of the Prepare to Care kit
Complete modules of the Prepare to Care kit
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.




Primary Outcome Measures :
  1. Acceptability assessed by survey [ Time Frame: At the end of radiotherapy, assessed up to 1 year ]
    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.

  2. Accrual assessed by number of caregivers who agreed to participate divided by the number of months of recruitment [ Time Frame: Up to 1 year ]
  3. Change in caregiver burden assessed by Caregiver Reaction Assessment (CRA) [ Time Frame: Before and after 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.

  4. Change in psychological distress Hospital Anxiety and Depression Scale [ Time Frame: Before and after radiotherapy, assessed up to 1 year ]
    14-item instrument that assess cognitive and behavioral symptoms of anxiety and depression; widely used in oncology populations. Scores range from 0-42, and scores >= 8 on each subscale indicates clinically significant symptoms.

  5. Change in quality of life assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) [ Time Frame: 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.

  6. Frequency of intervention modules utilized assessed by caregiver logs [ Time Frame: Up to 1 year ]
  7. Participation assessed by proportion of eligible participants who agreed to participate [ Time Frame: Up to 1 year ]
  8. 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 ]
  9. Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) [ Time Frame: Up to the end of radiotherapy, assessed up to 1 year ]
    3-item instrument developed for study to evaluate self-efficacy in APMR.

  10. Self-efficacy in coping with cancer caregiver inventory [ Time Frame: 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.

  11. Acceptability assessed by interview [ Time Frame: At the end of radiotherapy, assessed up to 1 year ]
    Qualitative interviews will further explore factors associated with overall acceptability. Acceptability will be summarized quantitatively and qualitatively.

  12. Salivary cortisol collection [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032250


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Chandylen Nightingale Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03032250    
Other Study ID Numbers: IRB00038084
NCI-2016-02045 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 99616 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
R03CA208560 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Hydrocortisone
Anti-Inflammatory Agents