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Completed

NCT Number: NCT03042715

Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)

This research study is evaluating a psychological intervention for caregivers of patients undergoing stem cell transplantation.

Phase 1 will include a qualitative phase to refine the intervention to specifically target the needs of caregivers

Phase 2 of the trial will transition to an interventional randomization clinical trial

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

About this study

The purpose of this study is to find out whether a psychological intervention can help caregivers learn effective coping methods during their loved one's transplant process and make the experience of being a caregiver more manageable.

Phase 1 of the project entails using qualitative interviews with caregivers to further refine the intervention. The psychological intervention will take place over the course of a patient transplant in a series of eight sessions. A trained behavioral psychologist will meet with the participant or talk with them over the telephone for 30-45 minutes at a time to discuss the caregiver experience and to help develop effective skills to support the patient as well as the participant over the course of the transplant.

Upon the completion of the sessions, the investigators will have a short, audio-recorded exit interview to obtain the participant's feedback on the intervention. At the participant's convenience, this interview will be conducted in-person or over the phone. The investigators will use the feedback to improve the intervention before further testing its efficacy in phase 2, a randomized clinical trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult caregivers (≥18 years) of patients undergoing HCT at MGH.
  • A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for transplant
  • Ability to speak English or able to complete questionnaires with minimum assistance of an interpreter.

Exclusion criteria

  • Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression)
  • Other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.

Treatment and study plan

Qualitative interviews

Behavioral

phase 1 of the study entail refining the psychological intervention based on caregivers' feedback

Primary outcomes

  1. Pilot Qualitative Refinement of the Caregiver Intervention

    Time frame: 1 year

    qualitative data to develop and refine the caregiver intervention

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2017
Registry last updated
Sep 1, 2021

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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