ACTIVE_NOT_RECRUITING

Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain

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 investigators aim to conduct a fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors. Both programs will be delivered virtually (Zoom).

Official Title

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study

Quick Facts

Study Start:2022-06-20
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05373745

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:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female outpatients, age 60 years or older
  2. * Have nonmalignant chronic pain for more than 3 months
  3. * Reports early cognitive decline (subjective or objective)
  4. * Telephone Interview for Cognitive Status-30 score greater than or equal to 17
  5. * Functional Activities Questionnaire score less than 9
  6. * Able to perform a 6-minute walk test at an accelerated pace
  7. * English fluency/literacy
  8. * Willingness and ability to participate and use an ActiGraph watch and smartphone app to view and sync the step count and sleep data
  9. * Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
  10. * Cleared by a medical doctor for study participation and no self-reported concerns about physical functioning on the revised Physical Activity Readiness Questionnaire (PAR-Q; score 0)
  1. * Diagnosed with dementia or neurodegenerative disease
  2. * Diagnosed with medical illness expected to worsen in the next 6 months
  3. * Diagnosed with serious untreated mental illness (i.e., schizophrenia) or untreated substance use disorder
  4. * Current suicidal ideation reported on self-report
  5. * Engaging in regular mindfulness practice \> 45 min/week or has completed a course of cognitive behavioral therapy in the past 3 months
  6. * Regular use of a digital-monitoring device
  7. * Engagement in regular intensive physical exercise for \>30 minute daily

Contacts and Locations

Principal Investigator

Ana-Maria Vranceanu, PhD
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

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 Date2022-06-20
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-06-20
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Chronic Pain
  • Mild Cognitive Impairment
  • Older Adults
  • Physical Activity
  • Memory Related Problems
  • Early Cognitive Decline

Additional Relevant MeSH Terms

  • Chronic Pain
  • Mild Cognitive Impairment
  • Older Adults
  • Physical Activity