Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05470010 |
Other study ID # |
SC28 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 30, 2024 |
Est. completion date |
December 31, 2026 |
Study information
Verified date |
January 2024 |
Source |
Canadian Cancer Trials Group |
Contact |
Harriet Richardson |
Phone |
613-533-6430 |
Email |
hrichardson[@]ctg.queensu.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
There is a need to develop, evaluate, and disseminate self-directed, easily accessible, safe,
affordable, and effective psychosocial interventions to people living with cancer (PLWC)
post-treatment. Smartphone app-based health interventions are an innovative way to deliver
psychosocial cancer-care. The Mindfulness-Based Cancer Survivorship (MBCS) Journey app is a
mobile app format of the Mindfulness-based Cancer Recovery program. In the SEAMLESS Study,
the investigators aim to evaluate the MBCS Journey app (a 4 week mind-body intervention) in
cancer survivors post-treatment. This is a randomized wait-list controlled trial.
Participants will either be assigned into the immediate group (will receive intervention
immediately after enrollment) or the waitlist group (wait for 3 months before receiving the
intervention).
Description:
BACKGROUND: Cancer patients who are transitioning into the survivorship phase after
completing their final treatments often have unmet needs that are different than those faced
during the diagnosing phase or treatment phase of their journey. PLWC tend to experience late
and long-term effects such as pain, fatigue, and distress. They can also experience
psychosocial stressors such as anxiety, depression, uncertainty about the future, and the
fear of cancer reoccurrence, which can negatively impact their mental health.
Cancer survivors are often unable to receive the face-to-face care they need due to barriers
such as compromised immunity, treatment-related side effects, scheduling conflicts, and
geography. Having a smartphone app-based mind-body intervention can help patients overcome
several of these barriers since they are able to participate in at their own convenience in
the comfort of their own home without the burden of travelling to and scheduling these
classes.
INTERVENTION DESIGN: The AM smartphone app (where MBCS Journey can be found) supports
personalized mindfulness practices through lessons and personalized guided-meditation
playlists. The AM app is able to interpret its users' emotional state e.g. angry, elated.
from a user-inputted digital emotion-mapping board; and heart-rate data through algorithms
that analyze facial bio-signals. The SEAMLESS study aims to evaluate AM's effectiveness for
reducing stress (primary outcome), anxiety, depression, fatigue, and overall physical
functioning and quality of life (secondary outcome) as well as determining the mechanisms of
action. In addition, there are two exploratory objectives: 1) to explore the sex, and
gender-based differences in significant outcomes as well as subgroup effects by cancer stage,
type, ethnicity, and age and 2) explore the correlation between self-reported stress
reduction and app usage and the correlation between stress ratings and psycho-biometric data
collected within the app. Outcomes will be assessed using validated Calgary Symptoms of
Stress Inventory (for stress), the PROMIS measure (for anxiety, depression, fatigue, and
overall physical functioning), and the European Organization for Research and Treatment of
Cancer quality of life questionnaire (for quality of life). Assessments will occur at 1)
baseline, 2) post-intervention, 3) 3 month after baseline follow-up, and 4) 6 month
post-intervention follow-up.
SIGNIFICANCE: In today's digital world, there are many app-based interventions for patients
but cancer-care providers are uncertain about their efficacy. Our study will provide
rigorously evaluated efficacy data for a smartphone app-based mind-body intervention for
cancer survivors, which if helpful, could be made easily available for psychosocial care at
cancer centers worldwide.