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

Post Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Adaptation of Coping Together, Self-directed Coping Skills Training Manuals for Patients and Caregivers in the Context of Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02928185
• Other study ID #: 16-1334
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: September 2024

Study information

• Verified date: October 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Hematopoietic Stem Cell Transplantation

Intervention

Behavioral:
• semi-structured interviews

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	City University of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	finalize the preliminary adaptation of the manuals	Socio-demographic characteristics will be summarized with descriptive statistics (frequencies, percentages, means, standard deviations) using IBM SPSS® Statistics, Version 22.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center