Cancer SurvivorsNCT03695406
Mind Body Program for Fear of Recurrence
A study testing Mind-Body Program for Fear of Recurrence in people with Cancer Survivors, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Mind-Body Program for Fear of Recurrence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 7 Jan 2022
- 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
- Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
- Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
- Ages 18 and older (by medical record and/or self-report)
Who cannot join
- Self-reported inability to speak and write in English
- Concurrent participation in weekly, group-based psychosocial or mind-body programs
- Serious mental illness (by medical record and/or self-report) as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year.
- Inability to travel to necessary study visits
- No e-mail address to access online assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medial Center
Boston, Massachusetts, 02215
About this study
This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors.
- Conditions
- Cancer Survivors
- Being tested
- Mind-Body Program for Fear of Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Program for Fear of RecurrenceBehavioural
An adapted protocol of the Relaxation Response Resiliency Program, a manualized, group-based, multimodal mind body program. Protocol adaptation includes refinement of content and study procedures to target fear of cancer recurrence (FCR) among adult cancer survivors.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Group Intervention | Experimental | Not described Receives: Behavioral: Mind-Body Program for Fear of Recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (i.e., retention at initial follow-up assessment)
The primary metric for assessing Feasibility will be retention at the initial follow-up assessment. Reasons for ineligibility, refusal, or dropping out will be measured.
Measured: Through study completion (approximately 5 months)
Acceptability
The primary metric for assessing Acceptability will be a five-item, investigator developed self-report questionnaire. Following each study session, participants will be asked to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the session.
Measured: During intervention group sessions (approximately 2 months)
Secondary outcomes (1)
Fear of Cancer Recurrence
Fear of Cancer Recurrence Inventory. Validated self-report measure of fear of cancer recurrence. 42 items across 7 subscales (triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance). Higher scores indicate more fear of recurrence. Severity subscale score ≥16 indicates elevated FCR.
Measured: Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start9 Aug 2017
- Primary completion30 Jun 2019
- Study completion7 Jan 2022
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 Cancer SurvivorsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695406
- Sponsor's protocol ID
- 2017P000168
- Status last verified
- Jan 2022
- First submitted
- 2 Oct 2018
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall DL, Park ER, Cheung T, Davis RB, Yeh GY. A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors. J Psychosom Res. 2020 Oct;137:110215. doi: 10.1016/j.jpsychores.2020.110215. Epub 2020 Aug 10.
PubMed 32818720
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Program for Fear of Recurrence
- ClinicalTrials.gov ID
- NCT03695406
- Acronym / sponsor ID
- 2017P000168
- Conditions
- Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 4 Oct 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.
This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Group Intervention | Experimental | Behavioral: Mind-Body Program for Fear of Recurrence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
- Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
- Ages 18 and older (by medical record and/or self-report)
Key exclusion criteria (5 listed)
- Self-reported inability to speak and write in English
- Concurrent participation in weekly, group-based psychosocial or mind-body programs
- Serious mental illness (by medical record and/or self-report) as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year.
- Inability to travel to necessary study visits
- No e-mail address to access online assessments
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 |
|---|---|---|
| Mind-Body Program for Fear of RecurrenceAn adapted protocol of the Relaxation Response Resiliency Program, a manualized, group-based, multimodal mind body program. Protocol adaptation includes refinement of content and study procedures to target fear of cancer recurrence (FCR) among adult cancer survivors. | Behavioural | Mind-Body Group Intervention |
Primary outcome
Feasibility (i.e., retention at initial follow-up assessment)
Time frame: Through study completion (approximately 5 months)
The primary metric for assessing Feasibility will be retention at the initial follow-up assessment. Reasons for ineligibility, refusal, or dropping out will be measured.
Acceptability
Time frame: During intervention group sessions (approximately 2 months)
The primary metric for assessing Acceptability will be a five-item, investigator developed self-report questionnaire. Following each study session, participants will be asked to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the session.
1 secondary outcome
Fear of Cancer Recurrence
Time frame: Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 32818720Hall DL, Park ER, Cheung T, Davis RB, Yeh GY. A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors. J Psychosom Res. 2020 Oct;137:110215. doi: 10.1016/j.jpsychores.2020.110215. Epub 2020 Aug 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Program for Fear of Recurrence in people with Cancer Survivors, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 1 Feb 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (i.e., retention at initial follow-up assessment) (time frame: Through study completion (approximately 5 months)). The study lists 2 primary outcomes in all. 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 NCT03695406, 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 1 Feb 2022.