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

• ClinicalTrials.gov Identifier: NCT03557762
• Recruitment Status: Unknown
• First Posted: June 15, 2018
• Last Update Posted: March 18, 2019
• Sponsor: University of Calgary
• Information provided by (Responsible Party): Linda E. Carlson, University of Calgary

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer; Psychological	Behavioral: Mindfulness	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The SEAMLESS Study: A Clinical Trial Evaluation of a SmartphonE App-based MindfuLnEss Intervention for Cancer SurvivorS
• Actual Study Start Date: January 25, 2019
• Estimated Primary Completion Date: January 6, 2020
• Estimated Study Completion Date: June 6, 2020

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Symptoms of Stress [ Time Frame: 3 months ]
   Calgary - Symptoms of Stress Inventory (C-SOSI)

Secondary Outcome Measures :

1. Fear of Cancer Recurrence [ Time Frame: 3 months ]
   Fear of Cancer Recurrence Inventory (FCRI)
2. Anxiety - PROMIS [ Time Frame: 3 months ]
   PROMIS- Cancer Bank v1.0 - Anxiety
3. Depression - PROMIS [ Time Frame: 3 months ]
   PROMIS- Cancer Bank v1.0 - Depression
4. Fatigue - PROMIS [ Time Frame: 3 months ]
   PROMIS- Cancer Bank v1.0 - Fatigue
5. Physical Function - PROMIS [ Time Frame: 3 months ]
   PROMIS- Cancer Bank v1.1 - Physical Function
6. App-based User Data [ Time Frame: 3 months ]
   Users' self-reported stress, biometrics and engagement

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Alberta

Psychosocial Oncology, Cancer Control Alberta

Calgary, Alberta, Canada, T2N 3C1

Sponsors and Collaborators

University of Calgary

Investigators

• Principal Investigator: Linda Carlson, PhD; University of Calgary

More Information

• Responsible Party: Linda E. Carlson, Enbridge Research Chair in Psychosocial Oncology, University of Calgary
• ClinicalTrials.gov Identifier: NCT03557762
• Other Study ID Numbers: HREBA.CC-18-0029
• First Posted: June 15, 2018
• Last Update Posted: March 18, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to share IPD

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Linda E. Carlson, University of Calgary:

Cancer survivors; Smartphone app; Mindfulness