CompletedNot Applicable

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

United States35 participantsStarted 2017-05-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Six weeks post radiation therapy

Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment

Timeframe: Up to 1 year

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

Timeframe: Baseline and following radiotherapy, assessed up to 1 year

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

Timeframe: Before and after radiotherapy, assessed up to 1 year

Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)

Timeframe: Before and after radiotherapy, assessed up to 1 year

Frequency of Intervention Modules Utilized Assessed by Caregiver Logs

Timeframe: Up to 1 year

Number of Participants in Agreement to Perform Interventions

Trial details

NCT IDNCT03032250

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-10

Results submitted2021-04-23

View on ClinicalTrials.gov More Caregiver trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Six weeks post radiation therapy

Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment

Timeframe: Up to 1 year

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

Timeframe: Baseline and following radiotherapy, assessed up to 1 year

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

Timeframe: Before and after radiotherapy, assessed up to 1 year

Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)

Timeframe: Before and after radiotherapy, assessed up to 1 year

Frequency of Intervention Modules Utilized Assessed by Caregiver Logs

Timeframe: Up to 1 year

Number of Participants in Agreement to Perform Interventions