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

October 2, 2023 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Hematopoietic Stem Cell Transplantation and Their Caregivers at MSKCC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

City University of New York

Investigators

  • Principal Investigator: Tammy Son, BS, MS, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimated)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-1334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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