Mind Body Program for Fear of Recurrence

Cancer Survivors Clinical Trial

Official title:

Mind Body Program for Fear of Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695406
• Other study ID #: 2017P000168
• Status: Completed
• Phase: N/A
• Start date: August 9, 2017
• Est. completion date: January 7, 2022

Study information

• Verified date: January 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 7, 2022
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivors
• Recurrence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medial Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Fear of Cancer Recurrence	Fear of Cancer Recurrence Inventory. Validated self-report measure of fear of cancer recurrence. 42 items across 7 subscales (triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance). Higher scores indicate more fear of recurrence. Severity subscale score =16 indicates elevated FCR.	Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up