CancerNCT04876599
Mind-body Resiliency Intervention for Fear of Cancer Recurrence
A study testing IN FOCUS in people with Cancer and Coping Skills, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Coping Skills, Coping Behavior
- What is being tested?
- IN FOCUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Jul 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- History of non-metastatic, localized, or regional solid or blood malignancy(ies)
- Completion of primary cancer treatment (i.e., radiation, surgery, chemotherapy) and/or current use of long-term maintenance hormonal or biologic therapy
- Age ≥18 years
- Elevated fear of recurrence (FCRI severity score ≥16)
- MGB/BIDMC Medical Record Number (MRN)
Who cannot join
- Self-reported inability to speak and write in English
- Undertreated serious mental illness as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year
- Inability to access technology and/or sufficient internet to participate virtual groups sessions
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusett General Hospital Cancer Center
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Mass General at Emerson Hospital -- Bethke
Concord, Massachusetts, 01742
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
About this study
Official title: IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors
The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.
Read the detailed description
This is a randomized pilot feasibility trial (1:1 intervention versus usual care; a referral to community-based cancer survivor support group) that will use mixed methods (quantitative and qualitative) to evaluate the feasibility, acceptability, and preliminary effects of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (IN FOCUS) among cancer survivors with clinically elevated fear of recurrence (N = approximately 64).
Patient-reported outcomes on psychological and behavioral outcomes will be measured at T0 (baseline), T1 (post-intervention/approximately two months post-baseline), and T2 (three months post-intervention/approximately five months post-baseline). Exit interviews will be conducted after the T1 survey. Participants are expected to be in the study for approximately five months.
- Conditions
- Cancer, Coping Skills, Coping Behavior
- Being tested
- IN FOCUS, Usual Care
- Keywords
- Cancer, Coping Skills, Coping Behavior
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN FOCUSBehavioural
Adapted Resiliency Group Intervention
Usual CareBehavioural
Referral to Virtual Group Support
| Study group | Role | What they receive |
|---|---|---|
| Intervention (IN FOCUS) | Experimental | Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. Receives: Behavioral: IN FOCUS |
| Usual Care | Active comparator | Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Retention Rate
The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.
Measured: Baseline to approximately 2 months
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention.
Measured: Baseline to approximately 2 months
Secondary outcomes (2)
Fear of Cancer Recurrence
Fear of cancer recurrence (FCR) severity will be measured using the 9-item Fear of Cancer Recurrence Inventory severity subscale. Scores range from 0-36 with higher scores indicating greater FCR severity. To supplement this measure, open-ended questions in the exit interview will assess perceived changes in FCR.
Measured: Baseline, approximately 2 months, approximately 5 months
Resiliency
Resiliency will be measured using the 23-item Current Experiences Scale. Subscale scores and total scores (range from 0-115) will be computed, with higher scores indicating higher resiliency.
Measured: Baseline, approximately 2 months, approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start9 Jul 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Daniel Hall, Massachusetts General Hospital
- Investigators
- Daniel L Hall, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876599
- Sponsor's protocol ID
- 21-090
- Status last verified
- Oct 2023
- First submitted
- 3 May 2021
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Daniel L. Hall, PhD (hall@mgh.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Christie AJ, Bolden C, Park ER, Yeh GY, O'Cleirigh C, Peppercorn J, Denninger JW, Hirschberg AM, Lee H, Markwart M, Siefring E, Mizrach HR, Bullock AJ, Hall DL. Managing, not lessening, uncertainty: a novel mind-body intervention for fear of cancer recurrence. J Cancer Surviv. 2025 Sep 1. doi: 10.1007/s11764-025-01886-2. Online ahead of print.
PubMed 40887510Hall DL, Yeh GY, O'Cleirigh C, Wagner LI, Peppercorn J, Denninger J, Hirschberg AM, Lee H, Markwart M, Siefring E, Mizrach HR, Li R, Mian Z, Tsuchiyose E, Wen A, Bullock AJ, Park ER. Pilot Randomized Controlled Trial of IN FOCUS: A Mind-Body Resiliency Intervention for Fear of Cancer Recurrence. Psychooncology. 2024 Nov;33(11):e70026. doi: 10.1002/pon.70026.
PubMed 39549022
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT04876599
- Acronym / sponsor ID
- 21-090
- Conditions
- Cancer, Coping Skills, Coping Behavior
- Keywords
- Cancer, Coping Skills, Coping Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.
Detailed description
This is a randomized pilot feasibility trial (1:1 intervention versus usual care; a referral to community-based cancer survivor support group) that will use mixed methods (quantitative and qualitative) to evaluate the feasibility, acceptability, and preliminary effects of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (IN FOCUS) among cancer survivors with clinically elevated fear of recurrence (N = approximately 64).
Patient-reported outcomes on psychological and behavioral outcomes will be measured at T0 (baseline), T1 (post-intervention/approximately two months post-baseline), and T2 (three months post-intervention/approximately five months post-baseline). Exit interviews will be conducted after the T1 survey. Participants are expected to be in the study for approximately five months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (IN FOCUS) | Experimental | Behavioral: IN FOCUSParticipants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of non-metastatic, localized, or regional solid or blood malignancy(ies)
- Completion of primary cancer treatment (i.e., radiation, surgery, chemotherapy) and/or current use of long-term maintenance hormonal or biologic therapy
- Age ≥18 years
- Elevated fear of recurrence (FCRI severity score ≥16)
- MGB/BIDMC Medical Record Number (MRN)
Key exclusion criteria (3 listed)
- Self-reported inability to speak and write in English
- Undertreated serious mental illness as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year
- Inability to access technology and/or sufficient internet to participate virtual groups sessions
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 |
|---|---|---|
| IN FOCUSAdapted Resiliency Group Intervention | Behavioural | Intervention (IN FOCUS) |
| Usual CareReferral to Virtual Group Support | Behavioural | Usual Care |
Primary outcome
Feasibility: Retention Rate
Time frame: Baseline to approximately 2 months
The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
Time frame: Baseline to approximately 2 months
As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention.
2 secondary outcomes
Fear of Cancer Recurrence
Time frame: Baseline, approximately 2 months, approximately 5 months
Resiliency
Time frame: Baseline, approximately 2 months, approximately 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40887510Christie AJ, Bolden C, Park ER, Yeh GY, O'Cleirigh C, Peppercorn J, Denninger JW, Hirschberg AM, Lee H, Markwart M, Siefring E, Mizrach HR, Bullock AJ, Hall DL. Managing, not lessening, uncertainty: a novel mind-body intervention for fear of cancer recurrence. J Cancer Surviv. 2025 Sep 1. doi: 10.1007/s11764-025-01886-2. Online ahead of print.
- Derived from this study: PubMed 39549022Hall DL, Yeh GY, O'Cleirigh C, Wagner LI, Peppercorn J, Denninger J, Hirschberg AM, Lee H, Markwart M, Siefring E, Mizrach HR, Li R, Mian Z, Tsuchiyose E, Wen A, Bullock AJ, Park ER. Pilot Randomized Controlled Trial of IN FOCUS: A Mind-Body Resiliency Intervention for Fear of Cancer Recurrence. Psychooncology. 2024 Nov;33(11):e70026. doi: 10.1002/pon.70026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Daniel L. Hall, PhD (hall@mgh.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Daniel L Hall, PhD principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IN FOCUS in people with Cancer and Coping Skills, run by Massachusetts General Hospital at 5 sites 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 5 inclusion and 3 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Retention Rate (time frame: Baseline to approximately 2 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 NCT04876599, which also lists 2 linked publications.
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 12 Oct 2023.