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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

Tracking Information
First Submitted Date October 6, 2016
First Posted Date October 10, 2016
Last Update Posted Date October 14, 2022
Study Start Date September 2016
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2016)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adaptation of Skills Training Manuals for Patients Receiving Hematopoietic Stem Cell Transplantation and Their Caregivers
Official Title Adaptation of Coping Together, Self-directed Coping Skills Training Manuals for Patients and Caregivers in the Context of Hematopoietic Stem Cell Transplantation
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hematopoietic Stem Cell Transplantation and Their Caregivers at MSKCC
Condition Post Hematopoietic Stem Cell Transplantation
Intervention Behavioral: semi-structured interviews
Study Groups/Cohorts
  • HSCT patients
    Individual/dyadic semi-structured interviews between Day +100 to +130
    Intervention: Behavioral: semi-structured interviews
  • HSCT care givers
    Individual/dyadic semi-structured interviews between Day +100 to +130
    Intervention: Behavioral: semi-structured interviews
  • HSCT dyads
    Individual/dyadic semi-structured interviews between Day +100 to +130
    Intervention: 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
    Intervention: Behavioral: semi-structured interviews
Publications * Son T, Lambert S, Jakubowski A, DiCicco-Bloom B, Loiselle CG. Adaptation of Coping Together - a self-directed coping skills intervention for patients and caregivers in an outpatient hematopoietic stem cell transplantation setting: a study protocol. BMC Health Serv Res. 2018 Aug 29;18(1):669. doi: 10.1186/s12913-018-3483-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 28, 2022)		 41
Original Estimated Enrollment
 (submitted: October 6, 2016)		 27
Estimated Study Completion Date September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02928185
Other Study ID Numbers 16-1334
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Same as current
Current Study Sponsor Memorial Sloan Kettering Cancer Center
Original Study Sponsor Same as current
Collaborators City University of New York
Investigators
Principal Investigator: Tammy Son, BS, MS, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2022