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

Not Applicable

Completed

• Conditions: Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms
• Interventions: Behavioral: Supportive Therapy Group 2; Behavioral: Cognitive Existential Therapy Group 1

• Registration Number: NCT03270995
• Lead Sponsor: McGill University

Brief 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Status Verified: 2020-02
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Supportive Therapy Group 2	Behavioral: Supportive Therapy Group 2- Weekly two-hour group sessions
Group 1	Cognitive Existential Therapy Group 1	Behavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions

Primary Outcome Measures

Name	Time	Method
Fear of cancer recurrence inventory	up to 12 months post-intervention follow-up	Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI). The FCRI is a 42-item questionnaire that includes a global score as well as seven sub-scales including triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. A score of 13 or greater on the nine-item severity subscale (range 0-36) indicates clinical level of FCR \[55\]. The instrument has been shown to have adequate reliability and validity (construct validity; r=0.68 to 0.77; and reliability scores; α=0.95).

Secondary Outcome Measures

Name	Time	Method
Perceived risk of cancer recurrence	Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention	Perceived risk of cancer recurrence will be assessed using a one-item question where respondents indicate their level of perceived personal risk for a cancer recurrence over the last two days.
Uncertainty in Illness	Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention	Uncertainty in Illness will be measured by the Mishel Uncertainty in Illness Scale (MUIS-C) \[59\]. The MUIS-C consists of 23 items rated on a five-point Likert scale.
Cancer-specific distress	Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention	Cancer-specific distress with the Impact of Event Scale (IES)\]; The IES is a 15 items questionnaires that assesses cancer distress. It has two sub-scales, intrusive thoughts and avoidance, which provide a total score.
Intolerance of uncertainty	Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention	Intolerance of uncertainty with be measured with the Intolerance of Uncertainty Scale (IUS) \[58\]. The IUS is a 27-item four-factor questionnaire that represents uncertainty as stressful and upsetting, uncertainty as leading to the inability to act, uncertain events as being negative and to be avoided, and being uncertain as unfair.

Trial Locations

Locations (3)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada