NCT03270995

Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study

Efficacy of a Cognitive-existential Intervention to Address Fear of Recurrence in Women With Cancer: a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Studies show that cancer survivors have unmet needs, the most frequently cited being fear of recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of cancer patients and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased health care utilization. Little evidence exists that these problems are being addressed by current medical management.

Detailed description

The present study aims to further test this cognitive-existential group intervention for FCR in a randomized control clinical trial with women with breast or gynecological cancer. Participants will be recruited from Princess Margaret Hospital, Mount Sinai Hospital, the Jewish General Hospital, and the Ottawa Hospital. 144 cancer patients will be randomized to either receive the 6 week cognitive-existential group intervention or to a control group. The control group will also consist of six weekly sessions during which participants will discuss the challenges of living with a cancer diagnosis, but without a clear focus on FCR. Women randomized to participate in the study will a) be 18 years or older; b) have a first diagnosis of breast or gynecological cancer with stages between IIII; c) be disease free at the start of the group; d) gave clinical levels of fear of cancer recurrence; e) have clinical levels of distress; and f) have completed their cancer treatment.

Conditions

• Breast Neoplasms
• Ovarian Neoplasms
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Existential Therapy Group 1	Six group sessions of two hour each using a cognitive-existential group approach
BEHAVIORAL	Supportive Therapy Group 2	Six group session of two hour each using a supportive group approach.

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2017-09-01
• Last updated: 2020-02-20

Locations

3 sites across 1 country: Canada