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NCT Number: NCT03032250

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

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.

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Key information

Conditions

Caregiver Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Lymphoid Interstitial Pneumonia Malignant Head and Neck Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Paranasal Sinus 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 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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication intervention

Other

Attend interventionist sessions

Watch video

Other

Watch video on a DVD

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Module completion of the Prepare to Care kit

Other

Complete modules of the Prepare to Care kit

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Survey Administration

Other

Ancillary studies

Salivary cortisol collection

Other

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 outcomes

  1. Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions

    Time frame: Six weeks post radiation therapy

    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.

  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

    38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month

  3. Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)

    Time frame: Baseline and following 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. 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.

  4. Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)

    Time frame: Before and after radiotherapy, assessed up to 1 year

    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.

  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. 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.

  6. Frequency of Intervention Modules Utilized Assessed by Caregiver Logs

    Time frame: Up to 1 year

    Data on intervention resources used and time spent using them based on caregivers in intervention group

  7. Number of Participants in Agreement to Perform Interventions

    Time frame: Up to 1 year

    Participation assessed by number of eligible participants who agreed to participate and complete study interventions.

  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: At baseline and up to the end of radiotherapy, assessed up to 1 year

    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.

  10. Self-efficacy in Coping With Cancer Caregiver Inventory

    Time frame: At baseline and 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. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2017
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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