RECRUITING

Improving Health for Older Adults with Pain Through Engagement

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this project is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of a 10-week mind-body and walking program (GetActive+) vs treatment as usual (TAU). The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline (0 weeks), post-intervention (1 week after intervention completion), and 6-month follow-up. This study will receive support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).

Official Title

Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ Vs Treatment As Usual; IHOPE Study

Quick Facts

Study Start:2024-10-01
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06119698

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.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Older Adults (i.e., age \>=55)
  2. 2. Diagnosed musculoskeletal chronic pain of any type (e.g., pain \> 3 months)
  3. 3. Pain score \>=4 (moderate) on the Numerical Rating Scale
  4. 4. Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., \<4 errors)
  5. 5. No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
  6. 6. Self-reported ability to complete the 6-minute walk test
  7. 7. Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff
  8. 8. English fluency or Spanish fluency
  1. 1. Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
  2. 2. Individuals who are unwilling or unable to wear the ActiGraph device
  3. 3. Active suicidality

Contacts and Locations

Study Contact

Ana-Maria Vranceanu, PhD
CONTACT
617-724-4977
avranceanu@mgh.harvard.edu
Christine Ritchie, MD, MPH
CONTACT
617-726-1382
csritchie@mgh.harvard.edu,

Principal Investigator

Ana-Maria Vranceanu, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Christine Ritchie, MD, MPH
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Ana-Maria Vranceanu, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital
  • Christine Ritchie, MD, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Registration Dates

Study Start Date2024-10-01
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Older adults
  • Mind-body intervention
  • Chronic pain
  • ActiGraph
  • Community health center
  • Physical function

Additional Relevant MeSH Terms

  • Chronic Pain
  • Musculoskeletal Pain