Mindfulness App for Cancer Survivors

(SEAMLESS Trial)

Recruiting at 7 trial locations

Overseen By Harriet Richardson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Cancer Trials Group

Disqualifiers: Major communication difficulties, Untreated psychiatric disorders, Previous mindfulness experience, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

345 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, ongoing maintenance therapy, hormone-blocking therapies, and certain other treatments are allowed, so it's likely you can continue with your current medications.

What data supports the effectiveness of the treatment Mindfulness, Mindfulness-Based Interventions, Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy for cancer survivors?

Research shows that mindfulness-based interventions can help reduce psychological distress, depression, anxiety, and cancer-related fatigue in cancer patients and survivors, improving their overall quality of life. ^{1 2 3 4 5}

Is mindfulness safe for cancer survivors?

Mindfulness-based interventions, like meditation and relaxation, are generally considered safe for cancer survivors and have been used to help manage stress, anxiety, and depression without significant safety concerns. ^{1 5 6 7 8}

How is the Mindfulness App treatment for cancer survivors different from other treatments?

The Mindfulness App treatment is unique because it uses mindfulness-based interventions (MBIs) to help cancer survivors manage stress and improve emotional well-being through practices like meditation and relaxation, which can be done online or via mobile apps, making it accessible and cost-effective. ^{5 6 9 10 11}

What is the purpose of 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).

Research Team

Linda E Carlson

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for English or French-speaking cancer survivors over 18 who've finished primary treatment at least 2 weeks ago. They must be willing to practice mindfulness daily using an app and have a smartphone with internet. It's not for those with cognitive impairments, weekly mindfulness experience, or current major depression.

Inclusion Criteria

I finished my main cancer treatment at least 2 weeks ago.

Have access to a smartphone with data or wifi connection

I have been diagnosed with cancer at any stage.

Exclusion Criteria

I have untreated depression or other mental health issues that could affect my participation.

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; assessed using three questions from the Brief Screen for Cognitive Impairment (BSCI)), which could interfere with completing the intervention and/or the questionnaires (i.e. inability to read or write)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week smartphone app-based mindfulness intervention program

4 weeks

Self-directed app usage at home

Waitlist Control

Participants in the control group wait for 3 months before receiving the intervention

3 months

Follow-up

Participants are monitored for stress, anxiety, depression, fatigue, and quality of life

6 months

Assessments at baseline, post-intervention, 3 months, and 6 months

Treatment Details

Interventions

• Mindfulness

Trial Overview The study tests the 'MBCS Journey' app, a mobile version of Mindfulness-based Cancer Recovery program. Participants are randomly placed in two groups: one starts immediately, while the other waits three months before beginning the four-week mind-body intervention.

Participant Groups

Group I: Immediate Mindfulness Experimental Treatment 1 Intervention

A 4 week smartphone app-based mindfulness intervention program with in-app activities for 20-30 minutes everyday, with a minimum of 4 days of activity in a week.

Group II: Control Mindfulness Experimental Treatment 1 Intervention

No intervention and usual care 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.

Mindfulness is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Interventions for:

• Substance Abuse Treatment
• Anxiety Disorders
• Depression

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress Management
• Anxiety Disorders
• Chronic Pain

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Mindfulness-based interventions (MBIs) significantly reduce psychological distress in cancer patients and survivors, with a small but meaningful effect size (Hedges's g = 0.32) observed immediately after the intervention and a sustained effect (g = 0.19) at follow-up, based on a systematic review of 29 randomized controlled trials involving 3274 participants.

MBIs also positively impact secondary outcomes such as anxiety, depression, and sleep disturbances, with larger effects noted in studies that adhered closely to MBI protocols and involved younger participants, indicating that optimizing these interventions could enhance their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. Cillessen, L., Johannsen, M., Speckens, AEM., et al.[2021]

Mindfulness-based stress reduction (MBSR) significantly reduces depression and anxiety in breast cancer patients compared to usual care, based on a systematic review of three randomized controlled trials involving 327 subjects.

While MBSR shows promise in improving psychological health, it does not significantly increase spirituality, indicating that its benefits may be more focused on mental health rather than spiritual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Cramer, H., Lauche, R., Paul, A., et al.[2021]

The modified mindfulness-based stress reduction (MBSR) program for breast cancer patients showed promising effects on reducing psychological distress and improving quality of life, with significant improvements noted in distress, general wellbeing, and fatigue-related quality of life after 8 weeks.

Although the study did not meet its feasibility goals for enrollment and retention, 66.7% of participants completed at least 7 out of 8 sessions, indicating potential interest and benefit in mindfulness interventions for cancer recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. Salvador, C., Mark, P., Hoenemeyer, T., et al.[2022]

Both group face-to-face mindfulness-based cognitive therapy (MBCT) and individual internet-based mindfulness-based cognitive therapy (eMBCT) led to long-term reductions in psychological distress and increases in mental health-related quality of life over a nine-month follow-up period for 245 distressed cancer patients.

Patients who participated in eMBCT reported lower psychological distress compared to those in MBCT, particularly benefiting those with lower baseline mindfulness and conscientiousness, suggesting that eMBCT may be a more effective option for certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. Cillessen, L., Schellekens, MPJ., Van de Ven, MOM., et al.[2019]

Mindfulness-based interventions (MBIs) significantly reduce symptoms of depression, anxiety, and cancer-related fatigue (CRF) in cancer patients, with medium effect sizes maintained for at least three months after the intervention.

In a review of 36 studies involving 1,677 participants, MBIs were found to be more effective than control groups in alleviating anxiety and CRF symptoms, highlighting their potential as a valuable component of oncological treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis. Chayadi, E., Baes, N., Kiropoulos, L.[2022]

Mindfulness-based interventions (MBIs) significantly reduce short-term anxiety in cancer patients, with a standardized mean difference of -0.51 based on 23 trials involving 2339 participants.

MBIs also lead to reductions in short-term and medium-term depression and improve health-related quality of life, but no significant long-term anxiety reduction was observed after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A Systematic Review and Meta-analysis. Oberoi, S., Yang, J., Woodgate, RL., et al.[2020]

Mindfulness-based therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).

The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. Piet, J., Würtzen, H., Zachariae, R.[2022]

A 4-week mindfulness program for 36 cancer survivors led to significant reductions in perceived stress and sedentary time, along with improvements in sleep quality and daily physical activity after the intervention.

The study suggests that abbreviated mindfulness interventions are feasible and effective for cancer survivors, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. Wirth, MD., Franco, R., Wagner Robb, S., et al.[2019]

An 8-week internet-based Mindfulness-based Stress Reduction (iMBSR) program significantly reduced symptoms of depression, anxiety, and insomnia in 48 breast cancer survivors compared to those who did not participate.

Participants who practiced mindfulness for more than 30 minutes daily experienced the greatest improvements, suggesting a dose-response relationship where increased practice time leads to better psychological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychological Effect of Internet-Based Mindfulness-Based Stress Reduction on the Survivors of Breast Cancer During the COVID-19. Kang, C., Sun, S., Yang, Z., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Distress Management Through Mind-Body Therapies in Oncology. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A Systematic Review and Meta-analysis. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A randomized wait-list controlled trial of feasibility and efficacy of an online mindfulness-based cancer recovery program: the eTherapy for cancer applying mindfulness trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Psychological Effect of Internet-Based Mindfulness-Based Stress Reduction on the Survivors of Breast Cancer During the COVID-19. [2021]