Breast CancerNCT03484000
The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery During Chemotherapy Treatment
A study testing Online Mindfulness Based Cancer Recovery (MBCR) in people with Breast Cancer and Colorectal Cancer, run by University of Calgary at 1 site in Canada.
Trial summary
Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Chemotherapy Effect
- What is being tested?
- Online Mindfulness Based Cancer Recovery (MBCR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over the age of 18
- Diagnosed with either a) stage I-III HER 2 normal breast carcinoma or b) Stage II-III colorectal carcinoma
- Scheduled to undergo either neoadjuvant or adjuvant: a) FEC- D or AC-T chemotherapy or b) FOLFOX or CAPEOX chemotherapy
- Weekly access to high-speed internet
- Access to a computer/tablet/smart phone
- Able to attend MBCR classes at scheduled times
- Sufficient ability to speak and read English
- Willingness to be randomized into immediate or waitlist groups and complete all assessments
Who cannot join
- Metastatic patients
- Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder (self-report)
- Currently engaging in meditation one or more times per week within the previous year.
- Participation in an MBCR or MBSR program in the last five years.
- Cognitive impairment (>6 on the Brief Screen for Cognitive Impairment)
- Physical functional impairment that would interfere with the ability to participate in the intervention (on the PAR-Q questionnaire)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N3C1
Linda E Carlson, PhD, 14033553207, lcarlso@ucalgary.ca
About this study
Official title: The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery (MBCR) During Chemotherapy Treatment (CT) to Impact Fatigue, Side Effects and Quality of Life (QL) in a Randomized Waitlist Controlled Trial
Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms in cancer patients. The investigators propose to evaluate a pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or have compromised immunity.
Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and quality of life (secondary outcomes) as well as cognitive function and return to work (exploratory outcomes) over the course of treatment.
Read more
Methods: The study design is a randomized wait-list controlled trial, conducted during CT for patients with breast or colorectal cancer. Participants will take the 12-week online MBCR program at home within 2 weeks of randomization (immediate group) or after CT completion (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT (primary outcome) and 4) 12 months post-baseline.
Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent, delay or diminish aversive symptoms and side-effects associated with CT, particularly fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide and significantly lessen the burden of cancer treatments.
- Conditions
- Breast Cancer, Colorectal Cancer, Chemotherapy Effect
- Being tested
- Online Mindfulness Based Cancer Recovery (MBCR)
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness Based Cancer Recovery (MBCR)Behavioural
MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement
| Study group | Role | What they receive |
|---|---|---|
| Immediate MBCR group | Experimental | The Online Mindfulness Based Cancer Recovery (MBCR) program intervention is delivered in 12 weekly real-time interactive 55-minute sessions offered over consecutive weeks. Receives: Behavioral: Online Mindfulness Based Cancer Recovery (MBCR) |
| Waitlist control group | Other | Treatment as usual, followed by a delayed (wait-list) intervention of the same Online Mindfulness Based Cancer Recovery (MBCR) program after the post-CT assessment. Receives: Behavioral: Online Mindfulness Based Cancer Recovery (MBCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F 68) is the most commonly-used cancer-related fatigue scale. Using a 5-point Likert scale (from "not at all" to "very much"), the 13-items reflect participants' specific fatigue concerns in the past 7 days. The total score has well-established norms both in the literature and from our prior work and shows responsiveness to intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda E. Carlson, University of Calgary
- Investigators
- Linda E Carlson, PhD, Principal investigator, University of CalgaryBarry D Bultz, PhD, Study chair, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484000
- Sponsor's protocol ID
- HREBA.CC-18-0028
- Status last verified
- May 2023
- First submitted
- 24 Mar 2018
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Subnis UB, Farb NA, Piedalue KL, Speca M, Lupichuk S, Tang PA, Faris P, Thoburn M, Saab BJ, Carlson LE. A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 May 11;9(5):e15178. doi: 10.2196/15178.
PubMed 32390591
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery (MBCR) During Chemotherapy Treatment (CT) to Impact Fatigue, Side Effects and Quality of Life (QL) in a Randomized Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT03484000
- Acronym / sponsor ID
- HREBA.CC-18-0028
- Conditions
- Breast Cancer, Colorectal Cancer, Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms in cancer patients. The investigators propose to evaluate a pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or have compromised immunity.
Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and quality of life (secondary outcomes) as well as cognitive function and return to work (exploratory outcomes) over the course of treatment.
Methods: The study design is a randomized wait-list controlled trial, conducted during CT for patients with breast or colorectal cancer. Participants will take the 12-week online MBCR program at home within 2 weeks of randomization (immediate group) or after CT completion (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT (primary outcome) and 4) 12 months post-baseline.
Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent, delay or diminish aversive symptoms and side-effects associated with CT, particularly fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide and significantly lessen the burden of cancer treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate MBCR group | Experimental | Behavioral: Online Mindfulness Based Cancer Recovery (MBCR)The Online Mindfulness Based Cancer Recovery (MBCR) program intervention is delivered in 12 weekly real-time interactive 55-minute sessions offered over consecutive weeks. |
| Waitlist control group | Other | Behavioral: Online Mindfulness Based Cancer Recovery (MBCR)Treatment as usual, followed by a delayed (wait-list) intervention of the same Online Mindfulness Based Cancer Recovery (MBCR) program after the post-CT assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women over the age of 18
- Diagnosed with either a) stage I-III HER 2 normal breast carcinoma or b) Stage II-III colorectal carcinoma
- Scheduled to undergo either neoadjuvant or adjuvant: a) FEC- D or AC-T chemotherapy or b) FOLFOX or CAPEOX chemotherapy
- Weekly access to high-speed internet
- Access to a computer/tablet/smart phone
Key exclusion criteria (6 listed)
- Metastatic patients
- Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder (self-report)
- Currently engaging in meditation one or more times per week within the previous year.
- Participation in an MBCR or MBSR program in the last five years.
- Cognitive impairment (>6 on the Brief Screen for Cognitive Impairment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Mindfulness Based Cancer Recovery (MBCR)MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement | Behavioural | Immediate MBCR group, Waitlist control group |
Primary outcome
Fatigue
Time frame: 6 months
Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F 68) is the most commonly-used cancer-related fatigue scale. Using a 5-point Likert scale (from "not at all" to "very much"), the 13-items reflect participants' specific fatigue concerns in the past 7 days. The total score has well-established norms both in the literature and from our prior work and shows responsiveness to intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 32390591Subnis UB, Farb NA, Piedalue KL, Speca M, Lupichuk S, Tang PA, Faris P, Thoburn M, Saab BJ, Carlson LE. A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 May 11;9(5):e15178. doi: 10.2196/15178.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda E Carlson, PhD principal investigator
University of Calgary
Barry D Bultz, PhD study chair
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness Based Cancer Recovery (MBCR) in people with Breast Cancer and Colorectal Cancer, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda E Carlson, PhD (14033553207, lcarlso@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.