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Completed

NCT Number: NCT03695406

Mind Body Program for Fear of Recurrence

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.

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Key information

Conditions

Cancer Survivors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medial Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Through study completion (approximately 5 months)

    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.

  2. Acceptability

    Time frame: During intervention group sessions (approximately 2 months)

    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.

Secondary outcomes

  1. Fear of Cancer Recurrence

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

    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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Oct 4, 2018
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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