Adaptation of Skills Training Manuals for Patients Receiv... | NCT02928185

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

NCT02928185

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Oct 9, 2025Actual

Enrollment

41Actual

Phase

Not provided

Conditions

Post Hematopoietic Stem Cell Transplantation

Interventions

semi-structured interviews

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2016Actual

Primary Completion Date

Oct 7, 2025Actual

Completion Date

Oct 7, 2025Actual

First Submitted Date

Oct 6, 2016

First Submission Date that Met QC Criteria

Oct 6, 2016

First Posted Date

Oct 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2025

Last Update Posted Date

Oct 9, 2025Actual

Name	Class
City University of New York	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semi-structured interviews	Behavioral		HSCT Clinicians HSCT care givers HSCT dyads HSCT patients

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hematopoietic Stem Cell Transplantation and Their Caregivers at MSKCC

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Tammy Son, BS, MS, PhD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30157867	Derived	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.