NCT02928185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2025

Completed
Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

9.1 years

First QC Date

October 6, 2016

Last Update Submit

October 8, 2025

Conditions

Keywords

training manualspatients and caregivers16-1334

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

HSCT CliniciansHSCT care giversHSCT dyadsHSCT patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hematopoietic Stem Cell Transplantation and Their Caregivers at MSKCC

You may qualify if:

  • 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
  • HSCT Clinicians
  • Member of MSKCC BMT patient care team for at least one year
  • +5 more criteria

You may not qualify if:

  • 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
  • Patients or CGs who are participating in this study as individuals HSCT Clinicians
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Tammy Son, BS, MS, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 10, 2016

Study Start

September 13, 2016

Primary Completion

October 7, 2025

Study Completion

October 7, 2025

Last Updated

October 9, 2025

Record last verified: 2025-10

Locations