RECRUITING

Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life

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 study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

Official Title

Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial

Quick Facts

Study Start:2024-05-22
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05810259

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:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Resides in United States
  1. * Any individual who endorses any of the following criteria will be excluded from participation in this study:
  2. * Positive Health Screening Questions, as measured by the Health Screening Questionnaire (HSQ):
  3. * Pain, discomfort or pressure in the chest, difficulty breathing or shortness of breath, dizziness, fainting, or blackout, blood pressure with systolic greater than 140 or diastolic greater than 90, diagnosed or treated for any heart disease, heart murmur, chest pain (angina), palpitations (irregular beat), or heart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, or heart transplant, resting pulse greater than 100 beats per minute, any arthritis, back trouble, hip /knee/joint /pain, or any other bone or joint condition, personal experience or doctor's advice of any other medical or physical reason that would prohibit the participant from doing light to moderate physical exercise, personal physician's recommendation against participating in light to moderate physical exercise because of asthma, diabetes, epilepsy or elevated cholesterol or a hernia.
  4. * Positive Psychiatric Disorders Screening Questions:
  5. * Positive screen for depression, excluding suicide (PHQ-8) cutoff score \> 6
  6. * Positive screen for panic (SMPD) cutoff score \> 2
  7. * Positive screen for generalized anxiety (GAD-7) cutoff score \> 10
  8. * Positive screen psychosis (PDSQ) via psychosis section, cutoff score \> 3
  9. * Positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score \> 6

Contacts and Locations

Study Contact

David Klemanski, Psy.D., MPH
CONTACT
203.214.5426
david.klemanski@yale.edu

Principal Investigator

David Klemanski, Psy.D., MPH
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • David Klemanski, Psy.D., MPH, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2024-05-22
Study Completion Date2024-11

Study Record Updates

Study Start Date2024-05-22
Study Completion Date2024-11

Terms related to this study

Keywords Provided by Researchers

  • digital wellness interventions
  • wellness
  • mental health
  • mindfulness
  • exercise

Additional Relevant MeSH Terms

  • Wellness
  • Quality of Life
  • Anxiety
  • Depression