Evidence map›Paper›PMID 39549022›Full record

Trial reportPsycho-oncology2024

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

Daniel L Hall, Gloria Y Yeh, Conall O'Cleirigh, Lynne I Wagner, Jeffrey Peppercorn, John Denninger, April M Hirschberg, Hang Lee, Michaela Markwart, Emma Siefring and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psycho-oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04876599 (IN FOCUS), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04876599 nacompletednot on this map

IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors

TypeinterventionalSponsorMassachusetts General HospitalRan2021 to 2023Enrolled64ConditionsCancer, Coping Skills, Coping BehaviorArmsIN FOCUS, Usual Care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Daniel L HallMassachusetts General Hospital, Boston, Massachusetts, USA.
Gloria Y YehHarvard Medical School, Boston, Massachusetts, USA.
Conall O'CleirighMassachusetts General Hospital, Boston, Massachusetts, USA.
Lynne I WagnerLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
Jeffrey PeppercornMassachusetts General Hospital, Boston, Massachusetts, USA.
John DenningerMassachusetts General Hospital, Boston, Massachusetts, USA.
April M HirschbergMassachusetts General Hospital, Boston, Massachusetts, USA.
Hang LeeMassachusetts General Hospital, Boston, Massachusetts, USA.
Michaela MarkwartMassachusetts General Hospital, Boston, Massachusetts, USA.
Emma SiefringMassachusetts General Hospital, Boston, Massachusetts, USA.
Helen R MizrachMassachusetts General Hospital, Boston, Massachusetts, USA.
Raissa LiMassachusetts General Hospital, Boston, Massachusetts, USA.
Zainab MianMassachusetts General Hospital, Boston, Massachusetts, USA.
Erika TsuchiyoseMassachusetts General Hospital, Boston, Massachusetts, USA.
Angela WenMassachusetts General Hospital, Boston, Massachusetts, USA.
Andrea J BullockHarvard Medical School, Boston, Massachusetts, USA.
Elyse R ParkMassachusetts General Hospital, Boston, Massachusetts, USA.

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
Research Training in Complementary and Integrative MedicineT32AT000051 · NCCIH · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI GLORIA Y YEH · 1999 to 2026
$10.2M
Mentoring and Patient-Oriented Research in Mind-Body ExerciseK24AT009465 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI GLORIA Y YEH · 2017 to 2026
$1.3M
Examining Delivery of Integrated Tobacco Treatment in Cancer CareK24CA197382 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI PARK, ELYSE R. · 2015 to 2019
$841k
A Multimodal Mind-Body Intervention for Fear of Recurrence among Cancer SurvivorsK23AT010157 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI HALL, DANIEL LEE · 2019 to 2023
$785k
Center for Biomedical Informatics and Information Technology K24CA197382NCATS NIH HHS UL1 TR002541NCCIH NIH HHS K23 AT010157NCCIH NIH HHS K23AT010157NCCIH NIH HHS K24 AT009465NCCIH NIH HHS K24AT009465NCCIH NIH HHS T32 AT000051NCCIH NIH HHS T32AT000051NCI NIH HHS K24 CA197382The Harvard Clinical and Translational Science Center, National Center for Advancing Translational Sciences UL1TR002541
6 · The paper itself

Abstract

introductionFear 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.

objectiveThis pilot randomized controlled trial (NCT04876599) tested a synchronous, virtual mind-body group resiliency intervention for FCR (IN FOCUS).

methodAdults 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.

resultsFrom 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).

conclusionsFor 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.

Indexed as

Cancer SurvivorsFearNeoplasm Recurrence, LocalResilience, PsychologicalAdultAgedFeasibility StudiesFemaleHumansMaleMiddle AgedMind-Body TherapiesNeoplasmsPilot Projectscancerfear of recurrenceinterventionsPsycho‐Oncologyresiliencysurvivorship

Identifiers

PMID39549022
PMCPMC11780542

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.