Clinical trial NCT03270995: Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study
Official title: Efficacy of a Cognitive-existential Intervention to Address Fear of Recurrence in Women With Cancer: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Keywords: breast cancer
gynecological cancer
fear of cancer recurrence
clinical trial
randomized controlled trial
group therapy
intervention
cognitive-existential
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: Princess Margaret Hospital, Canada
name: University of Ottawa
name: Sir Mortimer B. Davis - Jewish General Hospital
First posted: 2017-09-01
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Fear of cancer recurrence inventory
timeFrame: up to 12 months post-intervention follow-up
Secondary outcomes:
measure: Cancer-specific distress
timeFrame: 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
measure: Perceived risk of cancer recurrence
timeFrame: 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
measure: Intolerance of uncertainty
timeFrame: 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
measure: Uncertainty in Illness
timeFrame: 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
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University and University Health Network
name: Christine Maheu, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.