Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270995
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Canadian Cancer Society Research Institute (CCSRI)
Princess Margaret Hospital, Canada
University of Ottawa
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by (Responsible Party):
Christine Maheu, 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Ovarian Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Behavioral: Cognitive Existential Therapy Group 1 Behavioral: Supportive Therapy Group 2 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Efficacy of a Cognitive-existential Intervention to Address Fear of Recurrence in Women With Cancer: a Randomized Controlled Clinical Trial
Study Start Date : October 2014
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Behavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions
Behavioral: Cognitive Existential Therapy Group 1
Six group sessions of two hour each using a cognitive-existential group approach

Active Comparator: Group 2
Behavioral: Supportive Therapy Group 2- Weekly two-hour group sessions
Behavioral: Supportive Therapy Group 2
Six group session of two hour each using a supportive group approach.




Primary Outcome Measures :
  1. Fear of cancer recurrence inventory [ Time Frame: 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 :
  1. Cancer-specific distress [ Time Frame: 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.

  2. Perceived risk of cancer recurrence [ Time Frame: 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.

  3. Intolerance of uncertainty [ Time Frame: 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.

  4. Uncertainty in Illness [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270995


Contacts
Layout table for location contacts
Contact: Lorena Baku, HBSc, CCRP 416-581-8631 Lorena.baku@uhn.ca

Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Christina Tomei    613-562-5800 ext 4903      
Principal Investigator: Sophie Lebel, C. Psych         
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G2C4
Contact: Lorena Baku, HBSc, CCRP    416-581-8631    lorena.baku@uhnresearch.ca   
Principal Investigator: Christine Maheu, RN, PhD         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3A 2A7
Contact: Christine Maheu    5146165954    christine.maheu@mcgill.ca   
Sponsors and Collaborators
McGill University
Canadian Cancer Society Research Institute (CCSRI)
Princess Margaret Hospital, Canada
University of Ottawa
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Christine Maheu, RN, PhD McGill University and University Health Network

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Christine Maheu, Principal Investigator, McGill University
ClinicalTrials.gov Identifier: NCT03270995     History of Changes
Other Study ID Numbers: RCT FCR
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christine Maheu, McGill University:
breast cancer
gynecological cancer
fear of cancer recurrence
clinical trial
randomized controlled trial
group therapy
intervention
cognitive-existential
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Recurrence
Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases