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

Study Overview
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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.

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.

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

Conditions
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Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms

Intervention / Treatment
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* Behavioral: Cognitive Existential Therapy Group 1
* Behavioral: Supportive Therapy Group 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first diagnosis of BC or GC with stages between I-III; disease-free at the start of the group; women aged 18 years or older; completion of treatment, with the exception of adjuvant chemotherapy or hormonal replacement therapy Exclusion Criteria: non-English speakers previous cancer recurrence enrolled in another group psychotherapy at the time of the start of the study or during the course of the 6 sessions 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Behavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions | Behavioral: Cognitive Existential Therapy Group 1<br>* Six group sessions of two hour each using a cognitive-existential group approach<br>|
| Active Comparator: Group 2<br>Behavioral: Supportive Therapy Group 2- Weekly two-hour group sessions | Behavioral: Supportive Therapy Group 2<br>* Six group session of two hour each using a supportive group approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of cancer recurrence inventory | 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). | up to 12 months post-intervention follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific distress | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, gynecological cancer, fear of cancer recurrence, clinical trial, randomized controlled trial, group therapy, intervention, cognitive-existential