Mind Body Program for Fear of Recurrence

NCT03695406 | Completed

• 1 other identifier: 2017P000168
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Survivors

Outcome Measures

Primary Outcomes (2)

• Feasibility (i.e., retention at initial follow-up assessment)

  The primary metric for assessing Feasibility will be retention at the initial follow-up assessment. Reasons for ineligibility, refusal, or dropping out will be measured.

  Through study completion (approximately 5 months)

• Acceptability

  The primary metric for assessing Acceptability will be a five-item, investigator developed self-report questionnaire. Following each study session, participants will be asked to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the session.

  During intervention group sessions (approximately 2 months)

Secondary Outcomes (1)

• Fear of Cancer Recurrence

  Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up

Study Arms (1)

Mind-Body Group Intervention

EXPERIMENTAL

Behavioral: Mind-Body Program for Fear of Recurrence

Interventions

Mind-Body Program for Fear of Recurrence 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.

Mind-Body Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Self-reported inability to speak and write in English
• Concurrent participation in weekly, group-based psychosocial or mind-body programs
• 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.
• Inability to travel to necessary study visits
• No e-mail address to access online assessments

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medial Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 32818720 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: August 9, 2017
• Primary Completion: June 30, 2019
• Study Completion: January 7, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)