← Back to Search

PATH-C Intervention for Caregivers of Blood Cancer Survivors (PATH-C Trial)

N/A

Recruiting

Led By Hermioni Amonoo, MD, MPP

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to speak English and able to complete questionnaires with minimal assistance of an interpreter as this is a feasibility trial of the PATH-C intervention which is currently only available in English

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

PATH-C Trial Summary

This trial will test if an intervention can help caregivers of HSCT patients with their emotional and physical wellbeing.

Who is the study for?

This trial is for adult caregivers of patients undergoing stem cell transplants at Dana-Farber Cancer Institute for blood cancers. Caregivers must be primary support, in regular contact with the patient, and able to speak English. Those caring for non-cancer conditions or with acute psychiatric issues or cognitive deficits that affect consent or participation are excluded.Check my eligibility

What is being tested?

The study tests a positive psychology intervention called PATH-C aimed at improving well-being, quality of life, and physical activity among caregivers of hematopoietic stem cell transplant recipients. Participants will be randomly assigned to receive this intervention as part of the trial's evaluation process.See study design

What are the potential side effects?

Since PATH-C is a psychological intervention rather than a drug, it may not have typical medical side effects; however, participants might experience emotional discomfort when discussing personal topics during sessions.

PATH-C Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can speak English and fill out forms with little help.

PATH-C Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 9, and week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 9, and week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 9, and week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PATH-C Intervention Feasibility

Secondary outcome measures

Anxiety Symptoms based on the HADS-Anxiety Subscale

Caregiver Quality of Life based on the CarGOQOL

Caregiving Burden based not the Caregiver Reaction Assessment (CRA)

+3 more

Other outcome measures

Flourishing

Gratitude

Life Satisfaction

+6 more

PATH-C Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PATH-CExperimental Treatment1 Intervention

Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care. Caregivers of patients undergoing HSCT will receive the PATH-C intervention to learn to reflect on their positive emotions and consistently use and incorporate positive psychology exercises in their daily routine, as well as learn how to set goals and track their physical activity (i.e., with an activity tracker) daily while caring for a loved one undergoing HSCT. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.

Group II: Usual CareActive Control1 Intervention

Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. Participants in the usual care arm will receive their usual support from the HSCT team as caregivers of patients undergoing HSCT, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team. Patients in the usual care and PATH-C groups will be permitted to use all supportive care services per standard care. The investigators will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,870 Total Patients Enrolled

2 Trials studying Blood Cancers

90 Patients Enrolled for Blood Cancers

Robert Wood Johnson FoundationOTHER

157 Previous Clinical Trials

686,754 Total Patients Enrolled

American Society of HematologyOTHER

12 Previous Clinical Trials

20,910 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still open spots available in this trial?

"According to records on clinicaltrials.gov, this medical trial has stopped recruiting participants as of November 23rd 2023 - the date of its last update. Despite this fact, there are still 2680 other trials that require enrolment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors

Hermioni L.Amonoo, MD, MPP 2024. "A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153797.