NCT03557762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 25, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2020

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

June 4, 2018

Last Update Submit

May 19, 2022

Conditions

CancerPsychological

Keywords

Cancer survivorsSmartphone appMindfulness

Outcome Measures

Primary Outcomes (1)

  • Symptoms of Stress

    Calgary - Symptoms of Stress Inventory (C-SOSI)

    3 months

Secondary Outcomes (6)

  • Fear of Cancer Recurrence

    3 months

  • Anxiety - PROMIS

    3 months

  • Depression - PROMIS

    3 months

  • Fatigue - PROMIS

    3 months

  • Physical Function - PROMIS

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Immediate Mindfulness

EXPERIMENTAL

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

Waitlist Control Mindfulness

OTHER

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

Interventions

MindfulnessBEHAVIORAL

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.

Immediate MindfulnessWaitlist Control Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over the age of 18
  • Diagnosed with any type of cancer (stage I-III)
  • 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)
  • Willing to devote 20-30 mins of time to do the mindfulness meditations and practices every day
  • Sufficient cognitive function to participate in the smartphone app-based intervention
  • Ability to speak and write English sufficiently to complete questionnaires

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychosocial Oncology, Cancer Control Alberta

Calgary, Alberta, T2N 3C1, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Linda Carlson, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Enbridge Research Chair in Psychosocial Oncology

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 15, 2018

Study Start

January 25, 2019

Primary Completion

January 6, 2020

Study Completion

August 6, 2020

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

CA(1)