Active — Not RecruitingNot Applicable

Evaluating Stress Management Among Allogeneic HCT Caregivers

United States505 participantsStarted 2021-09-16

Plain-language summary

The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.

Who can participate

Age range

21 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: * Caregiver Inclusion Criteria: * Caring for a patient planning to receive an allogeneic HCT at Moffitt * Intending to remain primary caregiver throughout patient treatment (i.e., will be the caregiver the majority of the time) * Able to provide informed consent * Able to read and write in English * Owns a smartphone and is willing to download the study app * Patient Inclusion Criteria: * Receiving an allogeneic HCT at the cancer center * Able to provide informed consent * Able to read and write in English Exclusion Criteria: * Under 21 years of age * Unable to provide informed consent * Unable to read and write in English * Caregiver is unable to remain primary caregiver throughout patient treatment * Patient does not receive transplant at Moffitt Cancer Center

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

Caregiver Burden at End of Treatment

Timeframe: Up to 8 Weeks

Caregiver Burden at 2 Month Follow-up

Timeframe: 2 month follow up after end of treatment

Caregiver Burden at 6 Month Follow-up

Timeframe: 6 month follow up after end of treatment

Patient Distress at End of Treatment (CESD)

Timeframe: Up to 8 Weeks

Patient Distress at End of Treatment (GAD-7)

Timeframe: Up to 8 Weeks

Patient Distress at 2 Month Follow-up (CESD)

Timeframe: 2 Month Follow-up after end of treatment

Patient Distress at 2 Month Follow-up (GAD-7)

Timeframe: 2 Month Follow-up after end of treatment

Trial details

NCT IDNCT05078229

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-24

View on ClinicalTrials.gov More Burden trials

Who can participate

Age range

21 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.