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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270995
• Other study ID #: RCT FCR
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive Existential Therapy Group 1
Six group sessions of two hour each using a cognitive-existential group approach
• Supportive Therapy Group 2
Six group session of two hour each using a supportive group approach.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
McGill University	Canadian Cancer Society Research Institute (CCSRI), Princess Margaret Hospital, Canada, Sir Mortimer B. Davis - Jewish General Hospital, University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Maheu C, Lebel S, Courbasson C, Lefebvre M, Singh M, Bernstein LJ, Muraca L, Benea A, Jolicoeur L, Harris C, Ramanakumar AV, Ferguson S, Sidani S. Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer. BMC Cancer. 2016 Apr 25;16:291. doi: 10.1186/s12885-016-2326-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; a=0.95).	up to 12 months post-intervention follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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