RECRUITING

A Mobile Intervention to Reduce Pain and Improve Health-III

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 experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging. Unfortunately, while as many as three in four older adults experience chronic pain, few have access to effective non-pharmacological pain management strategies. Participating in regular physical activity, avoiding sustained sitting, and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain, and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term. Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss, and lasting weight maintenance, with pilot data suggesting this may contribute to improved pain, physical function, and health-related quality of life among older adults with chronic pain. As these were NIH Stage I trials, there are several important gaps to be addressed in the present trial: (1) both studies of chronic pain recruited small samples and were 12 weeks in duration, limiting our ability to establish efficacy and the durability of changes to activity, HRQOL, and pain outcomes; (2) participants included anyone with chronic pain, regardless of pain type, a likely contributor to heterogeneous pain intensity and interference findings; and (3) the investigators have yet to examine behavioral maintenance. The overarching goal of the proposed Stage II "mobile intervention to reduce pain and improve health-III (MORPH-III)" is to establish the efficacy of the intervention for enhancing physical activity via steps (primary), and for reducing pain interference and body weight while enhancing physical function (secondary) among older adults with chronic knee or hip osteoarthritic (OA) pain. The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls. This will be followed by a 12-month no-contact maintenance period, where participants will attempt to sustain behavioral goals on their own. The Specific Aims are: Specific Aim 1: To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control. Hypotheses: MORPH will significantly increase steps relative to control at month 6. Specific Aim 2: To examine the impact of MORPH on pain interference, change in body weight, and physical function relative to the enhanced usual care control. Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6. Exploratory Aims: Aim 1: To investigate the impact of the MORPH intervention on steps, weight change, pain interference, and physical function at month 18. Aim 2: If the MORPH intervention results in reduced pain interference at 6 and/or 18 months, the investigators will examine the extent to which 6-month change in steps, weight, pain self-efficacy, and catastrophizing mediate change in interference at 6 and/or 18 months.

Official Title

A Mobile Intervention to Reduce Pain and Improve Health-III

Quick Facts

Study Start:2025-06-17
Study Completion:2029-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06623669

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:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 65+ years
  2. * Body mass index of 30-45 kg/m2 or \>45 kg/m2 with physician approval
  3. * No loss or gain of more than 5% body mass in previous 6 months
  4. * Presence of knee or hip osteoarthritis as ascertained via the Roux questionnaire
  5. * Independently living
  6. * Low active (i.e., not participating in regular resistance training and/or \> 20 mins/day of aerobic exercise on more than 2 days/week in past 3 months as ascertained via a modified CHAMPS questionnaire)
  7. * Have no contraindication for safe and optimal participation in exercise
  8. * Not currently using a weight loss medication
  9. * Approved for participation by medical director
  10. * Willing to provide informed consent and agree to all study procedures and assessments.
  1. * Reside in skilled nursing facility, rehab or assisted living environment
  2. * History of pharmacologic treatment for a psychiatric disorder other than depression/anxiety within past year
  3. * Current untreated and/or unstable clinical depression or anxiety (Patient Health Questionnaire (PHQ-9) \>15)
  4. * Hospitalization for psychiatric event within past year prior to screening
  5. * History of mild cognitive impairment or dementia
  6. * Cognitive impairment (\<32) on Modified Telephone Interview for Cognitive Status survey (TICS-M)
  7. * Hearing or visual impairment that would preclude use of the videoconferencing software
  8. * Severe arthritis or other musculoskeletal disorder that is a contraindication for safe walking
  9. * Presently undergoing treatment for orthopedic fracture
  10. * Currently using a weight loss medication
  11. * Contraindication based on EASY screening without physician approval.
  12. * Joint replacement or other orthopedic surgery in past 6 months
  13. * Joint replacement or other orthopedic surgery planned in next 18 months
  14. * Have a diagnosis of uncontrolled hypertension; current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease; cancer requiring current treatment, except non-melanoma skin cancers; kidney failure requiring dialysis; have a Katz ADL disability; or engage in heavy alcohol use \>14 drinks/week.
  15. * Current participation in other research study with a prospective intervention
  16. * Unable/unwilling to commit to study protocol, including random assignment and use of technology tools
  17. * Unable/unwilling to attend three virtual testing appointments

Contacts and Locations

Study Contact

Deja O Dobson, MS
CONTACT
3367585042
dobsondo@wfu.edu
Jason Fanning, PhD
CONTACT
3367585042
fanninjt@wfu.edu

Principal Investigator

Jason Fanning, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University
Amber Brooks, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University
Winston Salem, North Carolina, 27109
United States

Collaborators and Investigators

Sponsor: Wake Forest University

  • Jason Fanning, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University
  • Amber Brooks, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

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 Date2025-06-17
Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-06-17
Study Completion Date2029-08-31

Terms related to this study

Keywords Provided by Researchers

  • Digital health
  • Randomized Trial
  • Physical Activity
  • Weight Loss
  • Aging

Additional Relevant MeSH Terms

  • Chronic Pain
  • Osteoarthritis
  • Obesity and Overweight
  • Inactivity