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

NCT02382315 | Completed

• 1 other identifier: 20150013-01H
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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

Cancer

Keywords

fear of cancer recurrence; psychosocial intervention; randomized controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• Fear of Cancer Recurrence Inventory

  The Fear of Cancer Recurrence Inventory (FCRI; Simard \& Savard, 2009) is a 42-item multidimensional instrument that has been used to examine FCR

  Up to 7 Months

Secondary Outcomes (8)

• The Impact of Events Scale

  Up to 7 Months

• Perceived Risk of Cancer Recurrence

  Up to 6 Months

• The SF-8 Health Survey

  Up to 7 Months

• The Intolerance of Uncertainty Scale

  Up to 7 Months

• The Mishel Uncertainty in Illness Scale - Community form

  Up to 7 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Fear of Cancer Recurrence Intervention.

Behavioral: Fear of Cancer Recurrence Intervention

Wait-list Control Group

NO INTERVENTION

Patients assigned to this arm will be asked to wait 6 weeks before being offered the fear of cancer recurrence intervention.

Interventions

Fear of Cancer Recurrence Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Men and women diagnosed with cancer (stages I-III),
• English-speaking,
• years of age or older,
• clinical level of FCR as indicated by a score of 13 or greater on the severity subscale of the FCRI (range 0-36),
• clinical distress score as indicated by a score of at least 24 on the IES (range 0-75),
• completion of cancer treatment,
• current or previous patients of the Ottawa Hospital Cancer Centre.

You may not qualify if:

• the refusal to provide informed consent,
• non-understanding of the English language,
• Stage IV cancer,
• previous cancer recurrence,
• currently enrolled in psychotherapy for cancer issues (whether individual or group) during the treatment,
• self-disclosure of unmanaged mental health disorder,
• have not been a patient of the Ottawa Hospital Cancer Centre.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

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MeSH Terms

Conditions

Neoplasms

Study Officials

• Monique Lefebvre, Ph.D.

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: March 6, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04