Mind Body Program for Fear of Recurrence

NCT ID: NCT03695406

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-09

Study Completion Date

2022-01-07

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Survivors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mind-Body Group Intervention

Group Type EXPERIMENTAL

Mind-Body Program for Fear of Recurrence

Intervention Type BEHAVIORAL

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.

Interventions

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Mind-Body Program for Fear of Recurrence

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
2. Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
3. Ages 18 and older (by medical record and/or self-report)

Exclusion Criteria

1. Self-reported inability to speak and write in English
2. Concurrent participation in weekly, group-based psychosocial or mind-body programs
3. 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.
4. Inability to travel to necessary study visits
5. No e-mail address to access online assessments
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Gloria Y. Yeh

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medial Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32818720 (View on PubMed)

Other Identifiers

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2017P000168

Identifier Type: -

Identifier Source: org_study_id

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