Pilot Randomized Controlled Trial of IN FOCUS: A Mind‐Body Resiliency Intervention for Fear of Cancer Recurrence.

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Title: Pilot Randomized Controlled Trial of IN FOCUS: A Mind‐Body Resiliency Intervention for Fear of Cancer Recurrence.
Authors: Hall, Daniel L. (AUTHOR), Yeh, Gloria Y. (AUTHOR), O'Cleirigh, Conall (AUTHOR), Wagner, Lynne I. (AUTHOR), Peppercorn, Jeffrey (AUTHOR), Denninger, John (AUTHOR), Hirschberg, April M. (AUTHOR), Lee, Hang (AUTHOR), Markwart, Michaela (AUTHOR), Siefring, Emma (AUTHOR), Mizrach, Helen R. (AUTHOR), Li, Raissa (AUTHOR), Mian, Zainab (AUTHOR), Tsuchiyose, Erika (AUTHOR), Wen, Angela (AUTHOR), Bullock, Andrea J. (AUTHOR), Park, Elyse R. (AUTHOR)
Source: Psycho-Oncology. Nov2024, Vol. 33 Issue 11, p1-11. 11p.
Subjects: Cancer relapse, Virtual communities, Groupoids, Exit interviewing, Likert scale
Abstract: Introduction: Fear of cancer recurrence (FCR) is prevalent and distressing among survivors of cancer. Evidence‐based mind‐body and cognitive‐behavioral skills lack integration and testing in scalable formats. Objective: This pilot randomized controlled trial (NCT04876599) tested a synchronous, virtual mind‐body group resiliency intervention for FCR (IN FOCUS). Method: Adults with elevated FCR (FCR Inventory severity ≥ 16; 16–21 = elevated, 22–36 = clinically elevated) after completing primary treatment for non‐metastatic cancer were randomly assigned (1:1) to eight weekly sessions of IN FOCUS or usual care (UC; synchronous, virtual community group support referral). Feasibility metrics included ≥ 70% retention per arm (primary outcome), ≥ 75% attendance in ≥ 6 sessions, ≥ 75% adherence to relaxation skills practice ≥ 3 days per week and by delivery fidelity (% content covered in video‐recorded sessions). Acceptability was assessed quantitatively via ratings of enjoyableness, convenience, helpfulness, odds of future use, and satisfaction (benchmark ≥ 80% of ratings ≥ 4 on 1–5 Likert scale) and qualitatively via individual exit interviews. Linear mixed models explicated slopes in FCR (secondary) and resiliency (exploratory; Current Experiences Scale) from baseline to 2 months (primary endpoint) and 5 months using intention‐to‐treat. Results: From July 2021 to March 2022, 64 survivors enrolled (25–73 years old, M = 7 years since diagnosis). IN FOCUS was feasible and acceptable (91% retention; attendance median = 7 sessions, 97% relaxation practice adherence, 95% content fully covered; 82% of acceptability ratings ≥ 4). Interviews (n = 59) revealed benefits in both arms. By 2 months, compared to UC, IN FOCUS reduced FCR to a medium‐to‐large effect (Mdiff = −2.4; 95% CI = −4.2, −0.7; d = 0.66). By 5 months, FCR effects had attenuated (Mdiff = −0.16, 95% CI −1.97, 1.65; d = −0.04), although levels of resiliency had increased with a medium‐to‐large effect (Mdiff = 10.0; 95% CI = 4.9, 15.1; d = 0.78). Conclusions: For survivors of non‐metastatic cancer, a synchronous, virtual mind‐body resiliency program for FCR is feasible, acceptable, and seemingly beneficial compared to a community group referral. [ABSTRACT FROM AUTHOR]
Copyright of Psycho-Oncology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Pilot Randomized Controlled Trial of IN FOCUS: A Mind‐Body Resiliency Intervention for Fear of Cancer Recurrence.
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  Data: <searchLink fieldCode="AR" term="%22Hall%2C+Daniel+L%2E%22">Hall, Daniel L.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yeh%2C+Gloria+Y%2E%22">Yeh, Gloria Y.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22O'Cleirigh%2C+Conall%22">O'Cleirigh, Conall</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wagner%2C+Lynne+I%2E%22">Wagner, Lynne I.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Peppercorn%2C+Jeffrey%22">Peppercorn, Jeffrey</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Denninger%2C+John%22">Denninger, John</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hirschberg%2C+April+M%2E%22">Hirschberg, April M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lee%2C+Hang%22">Lee, Hang</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Markwart%2C+Michaela%22">Markwart, Michaela</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Siefring%2C+Emma%22">Siefring, Emma</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mizrach%2C+Helen+R%2E%22">Mizrach, Helen R.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Li%2C+Raissa%22">Li, Raissa</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mian%2C+Zainab%22">Mian, Zainab</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tsuchiyose%2C+Erika%22">Tsuchiyose, Erika</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wen%2C+Angela%22">Wen, Angela</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bullock%2C+Andrea+J%2E%22">Bullock, Andrea J.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Park%2C+Elyse+R%2E%22">Park, Elyse R.</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Psycho-Oncology%22">Psycho-Oncology</searchLink>. Nov2024, Vol. 33 Issue 11, p1-11. 11p.
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  Data: <searchLink fieldCode="DE" term="%22Cancer+relapse%22">Cancer relapse</searchLink><br /><searchLink fieldCode="DE" term="%22Virtual+communities%22">Virtual communities</searchLink><br /><searchLink fieldCode="DE" term="%22Groupoids%22">Groupoids</searchLink><br /><searchLink fieldCode="DE" term="%22Exit+interviewing%22">Exit interviewing</searchLink><br /><searchLink fieldCode="DE" term="%22Likert+scale%22">Likert scale</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Introduction: Fear of cancer recurrence (FCR) is prevalent and distressing among survivors of cancer. Evidence‐based mind‐body and cognitive‐behavioral skills lack integration and testing in scalable formats. Objective: This pilot randomized controlled trial (NCT04876599) tested a synchronous, virtual mind‐body group resiliency intervention for FCR (IN FOCUS). Method: Adults with elevated FCR (FCR Inventory severity ≥ 16; 16–21 = elevated, 22–36 = clinically elevated) after completing primary treatment for non‐metastatic cancer were randomly assigned (1:1) to eight weekly sessions of IN FOCUS or usual care (UC; synchronous, virtual community group support referral). Feasibility metrics included ≥ 70% retention per arm (primary outcome), ≥ 75% attendance in ≥ 6 sessions, ≥ 75% adherence to relaxation skills practice ≥ 3 days per week and by delivery fidelity (% content covered in video‐recorded sessions). Acceptability was assessed quantitatively via ratings of enjoyableness, convenience, helpfulness, odds of future use, and satisfaction (benchmark ≥ 80% of ratings ≥ 4 on 1–5 Likert scale) and qualitatively via individual exit interviews. Linear mixed models explicated slopes in FCR (secondary) and resiliency (exploratory; Current Experiences Scale) from baseline to 2 months (primary endpoint) and 5 months using intention‐to‐treat. Results: From July 2021 to March 2022, 64 survivors enrolled (25–73 years old, M = 7 years since diagnosis). IN FOCUS was feasible and acceptable (91% retention; attendance median = 7 sessions, 97% relaxation practice adherence, 95% content fully covered; 82% of acceptability ratings ≥ 4). Interviews (n = 59) revealed benefits in both arms. By 2 months, compared to UC, IN FOCUS reduced FCR to a medium‐to‐large effect (Mdiff = −2.4; 95% CI = −4.2, −0.7; d = 0.66). By 5 months, FCR effects had attenuated (Mdiff = −0.16, 95% CI −1.97, 1.65; d = −0.04), although levels of resiliency had increased with a medium‐to‐large effect (Mdiff = 10.0; 95% CI = 4.9, 15.1; d = 0.78). Conclusions: For survivors of non‐metastatic cancer, a synchronous, virtual mind‐body resiliency program for FCR is feasible, acceptable, and seemingly beneficial compared to a community group referral. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Psycho-Oncology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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