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Adaptation of Skills Training Manuals for Patients Receiving Hematopoietic Stem Cell Transplantation and Their Caregivers

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: NCT02928185
Recruitment Status : Active, not recruiting
First Posted : October 10, 2016
Last Update Posted : October 14, 2022
Sponsor:
Collaborator:
City University of New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to see what the patients perceptions are of the Coping Together manuals during the first 100 days after their Hematopoietic Stem Cell Transplantation (HSCT), and if they would make any changes to Coping Together manuals for future patients, caregivers and couples that use these manuals after their HSCT. The investigators would also like to see what is the caregiver's perception of this intervention, and to see if they have any suggestions for changes. If the caregiver is interested in providing feedback, they will sign a separate consent form.

Condition or disease Intervention/treatment
Post Hematopoietic Stem Cell Transplantation Behavioral: semi-structured interviews

Detailed Description:

A two-part, qualitative descriptive design will be employed to systematically adapt the Coping Together manuals based on recommendations of HSCT patients, CGs, dyads and clinicians (for Phase 1 only). For this study, CG is defined as spouse, partner, family member, friend, colleague, or neighbor who can, but do not necessarily live together, and provide uncompensated care. A dyad is defined as a combination of a patient and their designated CG. Dyads can review the Coping Together manuals individually or jointly, but will be interviewed together.

Part 1 will capture diverse perspectives of HSCT patients, CGs, dyads and clinicians using individual (patients, CGs, clinicians) and dyadic (dyads) interviews for the preliminary adaptation of the Coping Together manuals.

Part 2 will explore the experiences of HSCT patients, CGs and dyads with HSCT CT, which will be the HSCT-modified version of the Coping Together manuals, using individual (patients, CGs) and dyadic (dyads) interviews to refine the HSCT CT manuals.

Study Design
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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptation of Coping Together, Self-directed Coping Skills Training Manuals for Patients and Caregivers in the Context of Hematopoietic Stem Cell Transplantation
Study Start Date : September 2016
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Groups and Cohorts
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Group/Cohort Intervention/treatment
HSCT patients
Individual/dyadic semi-structured interviews between Day +100 to +130
 Behavioral: semi-structured interviews
HSCT care givers
Individual/dyadic semi-structured interviews between Day +100 to +130
 Behavioral: semi-structured interviews
HSCT dyads
Individual/dyadic semi-structured interviews between Day +100 to +130
 Behavioral: semi-structured interviews
HSCT Clinicians
Can include: MD, RN, SW, PharmD and Nutritionist. Individual semi-structured interviews after 14 days to review the Coping Together manuals
 Behavioral: semi-structured interviews


Outcome Measures
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Primary Outcome Measures :
  1. finalize the preliminary adaptation of the manuals [ Time Frame: 1 year ]
    Socio-demographic characteristics will be summarized with descriptive statistics (frequencies, percentages, means, standard deviations) using IBM SPSS® Statistics, Version 22.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hematopoietic Stem Cell Transplantation and Their Caregivers at MSKCC
Criteria

Inclusion Criteria:

Part 1

HSCT Patients

  • Admission to the MSKCC Adult BMT service for an outpatient HSCT for a hematologic malignancy
  • HSCT procedure scheduled within two months of consent
  • ≥18 years old
  • Ability to read, speak and understand English
  • Able to give written informed consent
  • Physically and cognitively able to participate in the study as determined by the investigators HSCT CGs
  • ≥18 years old
  • Ability to read, speak and understand English
  • Able to give written informed consent
  • Physically and cognitively able to participate in the study as determined by the investigators

HSCT Dyads

  • In addition to meeting the inclusion criteria for HSCT Patients and HSCT CGs above, both parties must provide mutual agreement to participate as a dyad.

HSCT Clinicians

  • Member of MSKCC BMT patient care team for at least one year

Part 2

HSCT Patients

  • Same as Part 1 HSCT Patients HSCT CGs
  • Same as Part 1 HSCT CGs HSCT Dyads
  • Same as Part 1 HSCT Dyads

Exclusion Criteria:

Part 1 HSCT Patients

  • Physically and cognitively unable to participate in the study as determined by the investigators HSCT CGs
  • Inability to complete role responsibilities 24 hours per day for at least 50% of time (50 days)
  • Physically and cognitively unable to participate in the study as determined by the investigators HSCT Dyads
  • Participants must not meet the exclusion criteria for HSCT Patients and HSCT CGs above.
  • Patients or CGs who are participating in this study as individuals HSCT Clinicians
  • There are no exclusion criteria

Part 2 HSCT Patients

  • Same as Part 1 HSCT Patients HSCT CGs
  • Same as Part 1 HSCT CGs HSCT Dyads
  • Same as Part 1 Dyads
Contacts and Locations
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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): NCT02928185


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
City University of New York
Investigators
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Principal Investigator: Tammy Son, BS, MS, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02928185    
Other Study ID Numbers: 16-1334
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
training manuals
patients and caregivers
16-1334