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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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 . 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).
- 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.
- 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.
- 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) . 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.
- 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) . The MUIS-C consists of 23 items rated on a five-point Likert scale.
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
|Contact: Lorena Baku, HBSc, CCRP||416-581-8631||Lorena.firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Christine Maheu, RN, PhD|
|Jewish General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3A 2A7|
|Contact: Christine Maheu 5146165954 firstname.lastname@example.org|
|Principal Investigator:||Christine Maheu, RN, PhD||McGill University and University Health Network|