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A Therapy Intervention to Address Fear of Recurrence in Men and Women With Cancer

NCT02382315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-04-06

No results posted yet for this study

Summary

Fear of cancer recurrence (FCR) is one of the most frequently cited unmet needs among survivors, and affects 22 to 87% of cancer patients. The objective of this study is to test the effectiveness of a six weekly, 1-hour manual-based individual therapy to reduce FCR among cancer survivors. A total of n=20 cancer survivors will be recruited from the Ottawa Hospital Cancer Centre (TOHCC) in Ottawa, Ontario. Participants will be randomly selected to receive either the psychotherapy intervention or standard care at TOHCC. All participants will be asked to complete a series of questionnaire packages at 3 time points. Ultimately, decreasing FCR can improve quality of life and reduce distress.The objective of this RCT study is to test the effectiveness of a six weekly, 1 hour manual-based cognitive-existential (CE) individual intervention to reduce FCR among cancer survivors. It is hypothesized that:

1. Participants in the intervention group will have lower scores on the primary outcome measure of FCR after treatment, as compared to a standard care control group
2. Participants in the intervention group will have lower scores on the secondary outcome measures of uncertainty, cancer-specific distress, intolerance of uncertainty, and faulty beliefs about worrying, will demonstrate enhanced coping skills, and report better quality of life after treatment, as compared to a standard care control group, and these changes will be maintained at a 3-month follow-up.

Conditions

Interventions

BEHAVIORAL

Fear of Cancer Recurrence Intervention

A 6-week individual therapy intervention to address fear of cancer recurrence in male and female cancer survivors. Patients will learn tools and techniques to help manage their fears, and learn to tolerate the uncertainty associated with the possibility of their cancer recurring.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Monique Lefebvre, Ph.D. · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02382315 on ClinicalTrials.gov