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

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McGill University

Status

Completed

Conditions

Uterine Cervical Neoplasms
Ovarian Neoplasms
Breast Neoplasms
Endometrial Neoplasms

Treatments

Behavioral: Supportive Therapy Group 2
Behavioral: Cognitive Existential Therapy Group 1

Study type

Interventional

Funder types

Other

Identifiers

NCT03270995
RCT FCR

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

144 participants in 2 patient groups

Group 1
Experimental group
Description:
Behavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions
Treatment:
Behavioral: Cognitive Existential Therapy Group 1
Group 2
Active Comparator group
Description:
Behavioral: Supportive Therapy Group 2- Weekly two-hour group sessions
Treatment:
Behavioral: Supportive Therapy Group 2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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