Clinical trial NCT03557762: The SEAMLESS Study: Smartphone App-based Mindfulness for Cancer Survivors
Official title: The SEAMLESS Study: A Clinical Trial Evaluation of a SmartphonE App-based MindfuLnEss Intervention for Cancer SurvivorS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Psychological
Keywords: Cancer survivors
Smartphone app
Mindfulness
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. In the SEAMLESS study, the investigators aim to evaluate a 4 week smartphone app-based mind-body intervention (MBI) in cancer survivors post-treatment. This is a randomized controlled trial, with a waitlist control group. Participants will be assigned to either receive the intervention immediately after enrollment or will need to wait for 3 months to receive the intervention.

Detailed description: BACKGROUND Cancer patients who are in the transition phase to survivorship after completing their final treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. In the SEAMLESS study, the investigators aim to evaluate an app-based mind-body intervention (MBI) in cancer survivors.

The need for psychosocial interventions for cancer survivors has been highlighted by the Institute of Medicine in their landmark survivorship report appropriately titled, "Lost in Transition." Cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as compromised immunity, treatment-related side-effects, scheduling conflicts and geography. A smartphone-app based MBI can overcome several such difficulties, since patients can participate at their own convenience without the burden of travel and scheduling classes.

INTERVENTION DESIGN The AM smartphone app supports personalized mindfulness practices through lessons and personalized guided-meditation playlists; AM reportedly reduced anxiety in a study with college students. AM interprets 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 is a randomized wait-list controlled trial, which will evaluate AM's effectiveness for reducing stress (primary outcome), anxiety, depression, fatigue and fear of cancer recurrence in cancer survivors who have completed all treatments for 2 weeks or more. Outcomes will be assessed online using validated PROMIS measures at 1) baseline, 2) mid-point 3) immediately post-intervention, 4\&5) 3 and 6 months follow-up post-baseline.

SIGNIFICANCE Cancer-care providers are uncertain about the efficacy of app-based interventions for patients, which are available in great supply in today's digital world. This study will provide rigorously evaluated efficacy data for an app-based MBI for cancer survivors, which if helpful, could be made easily available for psychosocial care at cancer centers worldwide.

Eligibility criteria: Inclusion Criteria:

1. Men and women over the age of 18
2. Diagnosed with any type of cancer (stage I-III)
3. Completed active treatment (i.e. surgery, chemotherapy, radiation therapy) at least 4 months previously (ongoing hormonal therapies, AIs, tamoxifen, herceptin are not exclusionary)
4. Have access to a smartphone with data connection; in case patients' do not have a data plan or an insufficient data plan with their smart phone, we will pay for their data connection (up to 0.5GB/month)
5. Willing to devote 20-30 mins of time to do the mindfulness meditations and practices every day
6. Sufficient cognitive function to participate in the smartphone app-based intervention
7. Ability to speak and write English sufficiently to complete questionnaires

Exclusion Criteria:

1. Metastatic patients and those with ongoing chemotherapy (metastatic patients may not be stable enough to participate in the interventions and follow-up assessments).
2. Cognitive impairment that would interfere with completing questionnaires or the intervention.
3. Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder that would interfere with the ability to participate.
4. Practicing smartphone app-based mindfulness more than or equal to once a week

Primary outcomes:
measure: Symptoms of Stress
timeFrame: 3 months
Secondary outcomes:
measure: Fear of Cancer Recurrence
timeFrame: 3 months
measure: Anxiety - PROMIS
timeFrame: 3 months
measure: Depression - PROMIS
timeFrame: 3 months
measure: Fatigue - PROMIS
timeFrame: 3 months
measure: Physical Function - PROMIS
timeFrame: 3 months
measure: App-based User Data
timeFrame: 3 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Psychosocial Oncology, Cancer Control Alberta
state: Alberta
Study officials:
affiliation: University of Calgary
name: Linda Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References: