Health TrialsbyHealthPanel

Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors

ConditionsCancerPsychological
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult ≥ 18 years

Diagnosed with any type of cancer (stages I-IV)

Completed primary treatment (i.e. surgery, chemotherapy, radiation therapy) at least 2 weeks (14days) prior. Note: ongoing maintenance therapy, hormone-blocking therapies, intermittent bone-modifying agents, herceptin and targeted therapy with trastuzumab are not exclusionary.

Have access to a smartphone with data or wifi connection.

Disqualifiers

Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or cognitive impairment (score of ≤ 6; as assessed by the centre CRA using the three questions from the Brief Screen for Cognitive Impairment (BSCI)) listed in the screening CRF, which could interfere with completing the intervention and/or the questionnaires (i.e. inability to read or write)

Suffering from untreated Major Depressive Disorder or other psychiatric disorders that would interfere with participation. (Note: Participants will be referred for treatment and invited to call back once in remission).

Previous experience practicing in-person or app-based mindfulness once a week or more within the last year.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness

    Behavioral

    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.

Treatment groups

345 Participants
are divided into 2 treatment groups
Group A: Immediate MindfulnessExperimental treatment 1 intervention
Group B: Control MindfulnessOther 1 intervention

Trial outcomes

Primary outcomes

1

Calgary Symptoms of Stress Inventory (C-SOSI)

This is a 56 item scale. Each item is rated on a 5-point Likert scale (1-5). A higher score indicates higher levels of stress.

Time frame
3 months

Secondary outcomes

1

Total symptoms of stress from the C-SOSI to determine the impact of the one-month MBCS Journey intervention on stress immediately after the therapeutic intervention at one month from randomization

The C-SOSI refers to the 56-item Calgary Symptoms of Stress Inventory. There are 8 sub-scales (Depression, Anger, Muscle Tension, Cardiopulmonary Arousal, Sympathetic Arousal, Neurological/GI, Cognitive Disorganization, and Upper Respiratory symptoms) plus a TOTAL stress score.

Time frame
1 month after randomization
2

Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety

Short form (4 items). A higher score indicates higher levels of anxiety.

Time frame
3 months
3

Patient Reported Outcome Measurement Information System (PROMIS) - Depression

Short form (4 items). A higher score indicates higher levels of depression.

Time frame
3 months
4

Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue

Short form (4 items). A higher score indicates higher levels of fatigue.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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