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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN FOCUS | Behavioral | Adapted Resiliency Group Intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, approximately 2 months, approximately 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel L Hall, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusett General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40887510 | Derived | 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. |
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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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Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (IN FOCUS) | Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention |
| FG001 | Usual Care | 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. Usual Care: Referral to Virtual Group Support |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who consented and completed the baseline survey
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (IN FOCUS) | Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline to approximately 2 months |
|
Adverse events data was collected from all participants (n=64) and monitored throughout the duration of their study participation, approximately 5 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention (IN FOCUS) | Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Hall | Massachusetts General Hospital | +1 (704) 517-7273 | dhall7@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2023 | Aug 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2023 | Aug 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Usual Care |
| Behavioral |
Referral to Virtual Group Support |
|
| 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. | Baseline, approximately 2 months, approximately 5 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Mass General at Emerson Hospital -- Bethke | Concord | Massachusetts | 01742 | United States |
| Mass General/North Shore Cancer Center | Danvers | Massachusetts | 01923 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
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. Usual Care: Referral to Virtual Group Support |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participants could be included in more than one Race/Ethnicity category/row. | Count of Participants | Participants |
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| OG001 | Usual Care | 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. Usual Care: Referral to Virtual Group Support |
|
|
| Primary | 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. | This acceptability metric was assessed within the intervention arm only. | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 2 months |
|
|
|
| Secondary | 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. | Not all surveys were returned. | Posted | Mean | Standard Deviation | score on a scale | Baseline, approximately 2 months, approximately 5 months |
|
|
|
| Secondary | 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. | Not all surveys were returned. | Posted | Mean | Standard Deviation | score on a scale | Baseline, approximately 2 months, approximately 5 months |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Usual Care | 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. Usual Care: Referral to Virtual Group Support | 0 | 32 | 0 | 32 | 0 | 32 |
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| Title | Measurements |
|---|---|
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| Odds of Future Skills Use |
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| Overall Satisfaction |
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| 2 Months |
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| 5 Months |
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| 2 Months |
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| 5 Months |
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