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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-02-01

Brief Summary

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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.

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Detailed Description

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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

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Breast Neoplasms Ovarian Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

Behavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions

Group Type EXPERIMENTAL

Cognitive Existential Therapy Group 1

Intervention Type BEHAVIORAL

Six group sessions of two hour each using a cognitive-existential group approach

Group 2

Behavioral: Supportive Therapy Group 2- Weekly two-hour group sessions

Group Type ACTIVE_COMPARATOR

Supportive Therapy Group 2

Intervention Type BEHAVIORAL

Six group session of two hour each using a supportive group approach.

Interventions

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Cognitive Existential Therapy Group 1

Six group sessions of two hour each using a cognitive-existential group approach

Intervention Type BEHAVIORAL

Supportive Therapy Group 2

Six group session of two hour each using a supportive group approach.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. first diagnosis of BC or GC with stages between I-III;
2. disease-free at the start of the group;
3. women aged 18 years or older;
4. completion of treatment, with the exception of adjuvant chemotherapy or hormonal replacement therapy

Exclusion Criteria

1. non-English speakers
2. previous cancer recurrence
3. enrolled in another group psychotherapy at the time of the start of the study or during the course of the 6 sessions
4. unresolved mental health disorder judged to be clinically contra-indicated and/or likely to affect the group work, based on disclosure by the potential participant or clinically identified by the group leader.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No