The SEAMLESS Study: Smartphone App-based Mindfulness for Cancer Survivors

The SEAMLESS Study: A Clinical Trial Evaluation of a SmartphonE App-based MindfuLnEss Intervention for Cancer SurvivorS

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Psychological
• Intervention / Treatment: Behavioral: Mindfulness

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 3C1
      • Psychosocial Oncology, Cancer Control Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Mindfulness; A 4 week smartphone app-based mindfulness intervention program with in-app activities for 20-30 minutes every day, with a minimum of 4 days of activity in a week.	Behavioral: Mindfulness; A psychological behavioral intervention that trains participants in mindfulness techniques, which involves achieving a moment-to-moment non-judgmental awareness of their internal psychosocial-emotional state, through meditation and gentle mindful movements.
Other: Waitlist Control Mindfulness; No intervention for 4 weeks, after which there will be assessments immediately post-waiting and at 3 months post-baseline. After this, participants will get the same 4 week smartphone app-based mindfulness intervention program.	Behavioral: Mindfulness; A psychological behavioral intervention that trains participants in mindfulness techniques, which involves achieving a moment-to-moment non-judgmental awareness of their internal psychosocial-emotional state, through meditation and gentle mindful movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of Stress	Calgary - Symptoms of Stress Inventory (C-SOSI)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Cancer Recurrence	Fear of Cancer Recurrence Inventory (FCRI)	3 months
Anxiety - PROMIS	PROMIS- Cancer Bank v1.0 - Anxiety	3 months
Depression - PROMIS	PROMIS- Cancer Bank v1.0 - Depression	3 months
Fatigue - PROMIS	PROMIS- Cancer Bank v1.0 - Fatigue	3 months
Physical Function - PROMIS	PROMIS- Cancer Bank v1.1 - Physical Function	3 months
App-based User Data	Users' self-reported stress, biometrics and engagement	3 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Linda Carlson, PhD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): January 6, 2020
• Study Completion (Actual): August 6, 2020

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Mindfulness; Cancer survivors; Smartphone app
• Other Study ID Numbers: HREBA.CC-18-0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No